Reynaud’s syndrome (a syndrome of “dead fingers” on his arm). Diseases of the ear, nose and throat:

Almag 2 - Pulsed Electromagnetic Field Therapy for Legs

Please Note: PEMF devices are not contraindicated in course of chemotherapy and radiotherapy, the presence of stents, after coronary artery bypass grafting, in the presence of titanium structures

• The human cells in chronic, debilitating conditions have been rendered helpless and devoid of energy. Their cell walls have been progressively motionless. In order for those cells to be stirred back into life they need to ABSORB energy. They need to be jump-started back into motion.
• The human cell’s wall is like a rock. You can’t just strike it once and lean against it hoping it will move. You need to strike it repeatedly, from different angles to create a passage way and then you need to have enough energy to cause the cell to react too.
• PULSED Electromagnetic Field Therapies work by delivering ever changing waves of energy. These waves are constantly moving and thus are able to break through the cell walls much easier than a large force.
• TRAVELING PULSED Electromagnetic Field Therapies, such as that of the ALMAG-01 even further intensify the mechanism, by being able to deliver the energy from all around. Think of countless groups of Marines storming the wall from every possible direction while only the cell wall is guarded from the main entrance.

• Most of the cells in chronic conditions that need to be spurred back into life dwell deep within our tissues. The stem cells that lie dormant on the bottom have no chance of getting the energy required from static magnets.
• Pulsed Electromagnetic Field Therapies go as deep as 10-15 cm. Traveling Pulsed Electromagnetic Fields in the Almag-01 can go as far as 30 cm!
• And the best part about it… only the cells that really need the energy will absorb it, the rest of it passes right through. Why? Because Pulsed Electromagnetic Field Therapies operate at LOW-POWER that they are harmless. Almagia’s devices operate at the frequency close to the Earth’s NATURAL strength… around 7 Hz – and that’s the magic number.

3. EVEN IF the static magnets are able to penetrate deep enough, and get the cell into action, the body adapts to static magnets, and the therapies once believed to work lose their “luster”. This is what manufacturers of static magnets will never tell you about. And why should they… they will try to sell you a BIGGER magnet next!

Almag-01 - Traveling Pulsed Electromagnetic Field Therapy

• The body gets bored too. Do you listen to radio stations? After you hear the same darn song 20 times during the day… do you change the station? What if your car had only one station… would you turn off the radio? I would.
• Your body needs to go dancing. It needs a little motion. It needs a little push.
• Traveling Pulsed Electromagnetic Field Therapy is the ultimate dance machine. It dances to swing, rock & roll, salsa, tango, or can be toned down into a waltz. The body wants action and tPEMF will be the ultimate partner. tPEMF CREATES motion. It is only natural as that is exactly what our own planet delivers. As the Earth moves it delivers tPEMF from various angles and our bodies will never get bored.

4. What is ElectroMagnetic “Noise”? – Let’s be honest… Manufacturers of static magnets don’t want to tell you anything positive about electromagnetic magnets. The Electromagnetic “Pollution” or “Harmful PEMF” is NOT going to be found in the PEMF devices your doctors use or recommend. The Dangerous EMFs are rather those found in your microwave oven or the power lines outside your home. (Be very careful if you have powerlines going through your back yard. Protect your home with protective screens if you have them)

Disclaimer: As in ALL therapies, whether medical or alternative, every person is different and will react differently. There is no ONE device for all. Therefore it’s best to get your health care professional involved in the alternative treatments early on… WHY???

BECAUSE IF SOMETHING WORKS, TELLING ANOTHER PERSON ABOUT IT WILL POSSIBLY CHANGE THAT PERSON’S LIFE FOR THE BETTER. 

BUT IF YOU TELL YOUR DOCTOR OR THERAPIST … YOU HAVE THE UNIQUE CHANCE TO CHANGE THOUSANDS, IF NOT MILLIONS OF LIVES.

So tell your doctor about PEMF. Tell him because you may be able to turn a skeptic into a believer who can use his expertise to validate your personal experience and potentially influence the way medicine is practiced among his colleagues and the way it’s taught in medical schools. Please remember… Pulsed Electromagnetic Field Therapies have been used and studied extensively in Europe for over 60 YEARS… while it’s still “taboo” in the U.S. There’s no reason why we are still in the Dark Ages.

* Please note: the treatment program with integrated Pulsed Electromagnetic Field Therapy with the Almag-01 lasted only 2 weeks with the following results -

Osteoarthritis Treatment with Traveling Pulsed Electromagnetic Field Therapy

• Over a 51% reduction in cost of overall treatment program of Knee Arthrosis where the Almag-01 was integrated as compared to placebo.
• Decrease of Pain after the treatment program where Almag was integrated has been reported in 53% of Knee Arthrosis patients.
• Function & movement of the knee was 2.44 times greater in group where Almag electromagnetic field therapy was used.
• Also, the Almag group needed only 50% of the NSAIDs (pain medication) that the placebo group needed.

By William Pawluk, MD, MSc

Board Certified Family Physician and Holistic Health Practitioner; Former Assistant Professor at Johns Hopkins University School of Medicine and University of Maryland

Dr. Pawluk is the creator of www.drpawluk.com, an authoritative informational source on PEMFs. He has also authored a book, and appeared and consulted for the media, as well as universities conducting research.

Having healthy cells is not a passive process. Active, regular tuning-up of our cells is not only feasible, but also necessary to slow aging and reduce the risk of cell dysfunction. We are, after all, only as healthy as our cells. Imperceptible cell dysfunction that is not corrected early can lead to disease. Fine-tuning can be done daily in only minutes, using pulsed electromagnetic fields (PEMFs). In addition, when there is a known imbalance (when symptoms are present) or there is a known disease or condition, PEMF treatments, used either alone or along with other therapies, can often help cells rebalance dysfunction faster.

PEMFs work to:

• Reduce pain, inflammation, the effects of stress on the body, and platelet adhesion.
• Improve energy, circulation, blood and tissue oxygenation, sleep quality, blood pressure and cholesterol levels, the uptake of nutrients, cellular detoxification and the ability to regenerate cells.
• Balance the immune system and stimulate RNA and DNA.
• Accelerate repair of bone and soft tissue.
• Relax muscles.

PEMFs have been used extensively for decades for many conditions and medical disciplines, and results can be seen in animals as well as humans. The National Institutes of Health have made PEMFs a priority for research. In fact, many PEMF devices have already been approved by the FDA, some specifically to fuse broken bones, wound healing, pain and tissue swelling, and treat depression. Most therapeutic PEMF devices are considered safe by various standards and organizations.

What are PEMFs and how do they work?

Science teaches us that everything is energy. Energy is always dynamic and, therefore, has a frequency; it changes by the second or minute, for example, at the very least.

All energy is electromagnetic in nature. All atoms, chemicals and cells produce electromagnetic fields (EMFs). Every organ in thebody produces it own signature bioelectromagnetic field. Science has proven that our bodies actually project their own magnetic fields and that all 70 trillion cells in the body communicate via electromagnetic frequencies. Nothing happens in the body without an electromagnetic exchange. When the electromagnetic activity of the body ceases, life ceases.

Physics, that is, electromagnetic energy, controls chemistry. This in turn controls tissue function. Disruption of electromagnetic energy in cells causes impaired cell metabolism, whatever the initial cause. This happens anywhere in the disease process.

PEMFs address impaired chemistry and thus the function of cells – which in turn, improves health. PEMFs deliver beneficial, health-enhancing EMFs and frequencies to the cells. Low frequency PEMFs of even the weakest strengths pass right through the body, penetrating every cell, tissue, organ and even bone without being absorbed or altered! As they pass through, they stimulate most of the electrical and chemical processes in the tissues. Therapeutic PEMFs are specifically designed to positively support cellular energy, resulting in better cellular health and function.

Devices that produce PEMFs vary by a number of important features: frequency, waveform, strength, and types of stimulators. Frequencies can be simple or complex; and high, medium or low. Intensity can also be high, medium or low.

No “one-size” treatment fits all situations. Most PEMF devices help to varying degrees depending on the problem or condition, but selecting the wrong device may produce unsatisfactory results. Since the body is complex, PEMFs are ideal devices to be able get good results without needing a myriad of different treatments.

Aren’t some EMFs bad for you?

They can be. Evidence is mounting that a new form of pollution called “electrosmog” is a very real threat because it is disruptive to cell metabolism. Manmade, unnatural EMFs come from electrical wiring and equipment, for example, power lines, communications towers, computers, TVs, cell phones – everything from the wiring in our homes to fluorescent lighting to microwave ovens, hair dryers, clock radios, electric blankets and more.

Electrosmog EMFs are not designed with the body in mind. They can be a strong inducer of stress in the body and, therefore, drain our energy. Electrosmog includes “dirty” electricity, ground currents, microwaves and radio waves. Microwaves are not only from leaky microwave ovens, but also from cell towers, cell phones and wireless equipment.

Electrosmog is all around us and can only be partially blocked. One of the best solutions is to take measures to decrease your exposure. With therapeutic PEMFs, one can purposely add beneficial balancing frequencies to the body to decrease the burden of the negative effects of electrosmog.

PEMFs and Magnets: What’s the difference?

PEMFs are frequency-based, applied to either the whole body or parts of the body.  PEMFs may only be needed for short periods of time, while the effects last for many hours, setting in motion cellular and whole-body changes to restore and maintain balance in metabolism and health. The body does not acclimate, or “get used to,” the healthy energy signals of therapeutic PEMFs, even if used for a long time, compared to magnets.

Stationary (or “static”), non-varying, magnetic fields from magnets have fixed strengths. They are used in mattresses, bracelets, knee wraps and the like. Most have very shallow penetration into the body, resulting in a very limited ability to affect deeper tissues, and they rarely treat all the cells of the body simultaneously. Only skilled practitioners may guide you to get the bestresults from these approaches.

Experience with PEMFs

There are quite a number of PEMF systems available now in the US, for daily in-home use, that can help meet your unique needs. Some are FDA-approved and many more are available over-the counter or from various experienced practitioners. Some whole-body systems have been available in the US for over a decade and have been used in Europe by tens of thousands of people for a wide variety of problems without significant negative effects for over 20 years. One PEMF system has been studied through NIH-supported research at the University of Virginia for Rheumatoid Arthritis. These whole body systems have been used worldwide, not only by health-conscious individuals for health improvement and maintenance, but also by world-class and Olympic athletes for increased endurance, enhanced performance, and faster recovery.

What kind of doctor can help me with PEMFs?

Unfortunately, very few conventional, and even alternative or holistic, doctors know about these devices or this technological area. This is not a subject of mandatory education for doctors. Doctors often learn about these new technologies long after the public does, as has been seen with acupuncture. The process of educating doctors and other non-medical practitioners is growing all the time but will take years. Be patient and look for practitioners who have expertise in the area of PEMF therapies. – Dr. William Pawluk MD

Do you have questions? - Ask a Question

Find out more about Almagia’s magnetic therapy devices

Click here: For Latest Clinical Study with the ALMAG-01 PEMF in Knee OsteoArthritis

PEMFs, of the kind I usually recommend, typically penetrate all the way through the body without being used up by the body. However, like a light, the intensity of the light is strongest close to the light source and decreases as you move away from it. The same thing happens with PEMFs – the intensity drops off as you move away from the applicator. That means that the part of the body next to the applicator will get the highest field intensity and the other side of the body away from the applicator will get a very low level of intensity. This is an important consideration in where to place applicators and will determine often what kind of results will be obtained.

Some health problems require higher field intensities. Some health problems do better with lower field intensities. Some problems require a broader range of frequencies, while others do better with a minimal number of frequencies. So, selecting the right device becomes important to achieve the best results. Every magnetic system will produce benefits to some extent. The right magnetic system for the circumstances will tend to produce results faster. Unfortunately often people have to make purchasing decisions based on affordability and so the right magnetic system may not always be possible to obtain.
If this is the case, then it will likely take more time for benefits to be achieved and patience will be required.
Many people get tremendous results quickly and are very happy with their PEMF system even in the first week or so of use. For some people the results don’t happen quickly. This is where we can fine tune the treatment program to achieve better results. I often have to remind people that the body takes time to heal once it’s given the appropriate signal or stimulus for that to happen. For example, a fracture will need 8 to 12 weeks to be strong enough for the bone to be able to be used. This does not mean the healing process is finished, it is just a more usable body part. Magnetic therapy can speed the healing rate but it will not be instantaneous. This is an unreasonable expectation.

PEMFs do not drug the body into being painless or euphoric. I call that “numbing and dumbing.” Sometimes drugs are important during the therapy process. One of the goals of PEMFs is to be able to reduce the use of drugs if one can and accomplish less pain and improved function.
PEMFs work deep in the tissues to stimulate natural healing processes that have gotten stuck. It is the healing of the tissues that creates a reduction in pain, and improvement of function and health. This is ultimately the best solution and produces the most sustainable, least likely to regress, results. Unfortunately, we didn’t get here overnight with our problem/s and it will take time for the healing to work. Despite this, at the same time, other benefits begin to happen in the body, that were unexpected. For example, sleep, mood or vitality, or gut function, etc, may improve before the original problem improves.

So, what are some of the ways to improve results?

1. Setting expectations for magnetic therapy
Having proper expectations is really important. If one is depressed or very miserable in one’s life, small improvements in a problem may seem inadequate to improve the overall quality of one’s life. I see this particularly in the elderly who have so many health issues, among others, that it is hard for them to appreciate the benefits they may be getting. Important to setting expectations is understanding the nature of the problem the depth of the damage or dysfunction, the tissue involved and its ability to regenerate, the likely time it will take to recover even in favorable circumstances, and the age of the individual. It is clear that a 20-year-old will heal much faster than an 80-year-old. The body has more vitality and the genetics tends to support faster repair and recovery. 20-year-olds typically don’t have as many chronic problems and so acute injuries tend to resolve much faster than chronic problems, which have been around for decades. While often considerable funds are being spent on PEMFs we have a risk of setting expectations that are too high for what the technology can accomplish and the ability of the tissue to regenerate. When expectations are too high we are unfortunately often very likely to seek magic bullets, including surgery, expecting dramatic benefits. Rarely, miraculous things happen quickly, but this is not the norm. Still, PEMF therapies are a better solution than exposing the body to risky procedures or potentially toxic drugs/medications. PEMF therapies or a more natural solution, most of the time. Often, individuals will seek PEMFs as a solution after they have already been subjected to numerous procedures or surgeries. This unfortunately becomes a bit like putting Humpty Dumpty back together again. I have seen PEMFs work extremely well and quickly in patients who have very little damage in their bodies for multiple procedures. This can happen even in this last situation, if the circumstances are right. Most of the time, however, it takes time for healing to happen that is likely to be permanent or dependable. Often also, PEMFs may not cure or reverse the problem but are necessary on a continuing basis to maintain control of the problem. The same thing obviously happens with the use of medications, physical therapy, massage, etc.

2. Acknowledging the level of tissue damage/dysfunction before magnetic therapy
This is a critical piece to understanding how long it is likely to take for benefits to be seen in treating specific problems. Problems in the body have degrees of involvement and different tissues are involved in any given injury. The degrees of involvement can be considered in terms of layers or levels. One way to conceive of these levels is: the energetic level, the physiologic level, the pathophysiological level, and the pathologic level. At any given time there can be overlap in the tissues of all of these levels, and they can even all be simultaneously present.

Energetic level
The analogy I use is that of a common cold. When a cold is first beginning, many people feel a vague sense of disease, or uncomfortableness, without any specific sense of where or what the problem is. This is in the energetic level.

Physiologic level
Once a cold begins to produce a sore throat, a slight temperature, a runny nose, sneezing, etc., the infection has moved to the physiologic level.

Pathophysiologic level
If the infection continues in the body and progresses, it may begin to produce bronchitis, rhinitis, a significant cough, mental fogginess, with a green or yellow sputum, etc. This is the pathophysiologic level. In this level there are elements of a physiologic response to an infection and elements of cellular destruction (pathology) with color changes to the sputum indicating infection of the nose, sinuses or bronchial passages. Once the infection descends further into the body, acute sinusitis or pneumonia is possible. Most chronic problems are in the pathophysiologic level, with varying degrees of pathology.

Pathologic level
With significant cellular or organ damage, this level is considered pathologic. A substantial amount of tissue death can occur before an organ or the body as a whole will fail. At a minimum, a number of cells have died. At the extreme, there is either complete or partial organ failure or death of the person.

Responses to treatment at each level
Treatments directed at a problem that is at the energetic level are much more dramatic and likely to produce responses very rapidly, even in minutes. For physiologic level problems, treatments are more likely to produce responses in hours to several days. Once there is some level of pathology, that is, at a pathophysiologic level, the effects of treatment usually take longer, and can take days to weeks. The pathophysiologic level in these cases can be surprisingly affected by magnetic fields, with often dramatic results. At the pathologic level, treatments have very unpredictable results and may take months to years to produce results, if ever. True and complete organ death is unlikely to be reversible with magnetic fields. Magnetic fields do not create the “Lazarus effect”.
Once one knows what the probable level of damage to the organism is, it’s easier to predict how long it may take for these therapies to produce results. Miracles, that is, much better than expected results, are always possible, however. Treatment may be directed at a particular problem of interest but improvement may first be seen for a different issue, based on which layers are involved. Since more superficial layers will be more likely to respond quickly, these problems will respond regardless of where the MFs may be directed first. This is like peeling an onion; more superficial issues will be “peeled” away first, deeper next, etc. and deepest will be last. This is why holistic treatment may take months to years to clear all the layers.

As a physician, I always attempt to determine the level of damage that’s present in the person I am asked to help. Once I have a sense of the levels involved, I have a much better idea of how long it will take to achieve significant relief or improvement or cure. The level and extent of the problem seems to be more important than the strength of the magnetic fields applied, or the frequencies used or how much time is devoted to treatment each day. Optimizing these variables should shorten the process.

Beyond this, all bodies are different and all illnesses or diseases need to be well understood, along with some sense of the mind, body and spiritual states of the individual looking for treatment. All of these will determine how long treatments will take to produce expected or desired results. Without this sense of layers, both the individual seeking treatment and the therapist can experience unnecessary frustration. The body has its own wisdom and will respond in the layers and levels that make more sense to it than to our expectations or fantasies. We need to respect these layers of healing timelines and processes and work positively with them. What gets healed initially and in what order after that is mostly up to the body, not our expectations. The order of healing will follow the body’s own wisdom of what level/tissue should be cleared first, second, etc. Patience and acceptance of this natural order will aid the healing process.
The second aspect, beyond the levels of dysfunction, is the tissues involved. The body is constantly regenerating itself and we are informed that we are new bodies about every seven years. However, various tissues within the body have faster levels of regeneration and repair cycles than the overall body. For example, the cornea of the eye repairers itself 24 hours. Intestinal cells can repair within 72 hours. Skin and muscle cells may repair in 2 to 3 weeks. Bone can take up to seven years. Some tissues do not repair well, if at all, for example, ligaments, tendons, nerves, brain, spinal disks and possibly cartilage. The tissues that do not repair well generally do not have great blood supplies or have a low regenerative capacity. Since many problems for which PEMFs are used involve musculoskeletal tissues, these problems can be very stubborn to get results. Some problems are just very deep in the body and difficult to access without procedures to be able to produce benefits. This is one of the areas where PEMFs are especially useful, since they penetrate rate through the body. We cannot push the tissue to regenerate beyond its optimal capacity for regeneration. The optimal capacity is comparable to what would be seen in childhood. So, for example a fracture may take 8 to 12 weeks to heal to a point of functionality naturally. With the use of PEMFs this fracture may take half to three quarters of the usual time. It is known for example, with fractures that have not healed for over six months, that the use of PEMFs may be needed for upwards of 8 to 12 hours per day for as long as a year, depending on the fracture gap.

For tissues that do not have the capacity for regeneration, PEMFs are used in the circumstances to reduce pain, swelling in the tissues, improve circulation, and stimulate whatever regeneration is possible. Again, usually in any given problem there are multiple layers involved and multiple tissues. Since we never clearly know what the pain generator might be, the use of PEMFs can still be very valuable.

3. Adequate amount of use of the magnetic therapy device
Most of us are under significant time pressures. The amount of time for which treatments need to be applied, will depend on the levels of dysfunction, the tissue type and the particular magnetic system used. Generally speaking, faster results will be obtained with higher intensity PEMFs. Unfortunately, these are usually significantly more expensive PEMF systems. Therefore, if a lower intensity system is all that is affordable, longer treatment times will be needed for more extended intervals to achieve desired results. As mentioned above for nonunion fractures, treatments may need to be applied for upwards of 8 to 12 hours per day for upwards of a year. This is an unusual circumstance but generally, it may be necessary to use the PEMFs from 60 min to three hours per day on average. It is generally better to break up the treatment times to give gentle nudges to the body to stimulate the healing processes. So, a common recommendation I make is to do 30 min. three times a day. If this is not possible at least an attempt should be made to do 30 min. twice a day and when possible add another 30 min. session in the middle of the day. When time is available better results may be achieved with 60 min. three times a day. No matter what, at least one treatment session should be done daily usually around 30 min. at a time. One of the most important aspects of treatment with PEMFs is consistent daily application until the problem has improved.

Occasionally frequencies become important and for some problems higher frequency systems will do a better job faster, even if less intense. The same rules for time of use applies to these systems.

4. Duration of use of magnetic therapy devices
How long should magnetic therapies be applied for? The short answer is – as long as it takes. Many people stop doing their treatments as soon as they feel comfortable enough. It should be understood that the healing process is not finished itself because symptoms are better. PEMFs work
at the cellular level and are repairing and regenerating cells and improving the function of cells at a level way below our awareness. So, healing can take a lot longer than simple symptom reduction. This is one of the reasons we get into trouble in terms of chronic conditions because we don’t appreciate that problems are developing until they become symptomatic. A good example of this is hypertension which is silent until a stroke or heart failure occur. A general rule of thumb would be to continue treatments at the same level prior to symptom improvement for least another month. Another caution is that when symptoms have improved we should not necessarily increase our activity level dramatically because it may reenter the tissues. Activity should be increased gradually and the body will instruct us what is tolerable. When symptoms recur we know that we have gone too far too fast and need to back off and continue treatment for a longer period of time.

A common example where PEMF therapy is not always achieve desired results is in bone on bone arthritis. This could be the knee or the hip. In this circumstance the damage is so extensive and so late in the history that a joint replacement is often inevitable. Even though in this situation the opportunity for PEMFs to make a huge difference is limited, I’m constantly surprised at the benefits people get. If however, there is minimal benefit or the benefit is not a sufficient level of reduction of pain, there is still the benefit of assisting the tissues to be as healthy as possible prior to having their joint replacement. After the surgery, the recovery time for the joint replacement may actually be shortened with a decreased risk of complications. In addition, some research and feedback from patients indicates that the prosthesis integrates better with the bone. In addition there may be long-term benefits in having this osteointegration decrease the likelihood for future breakdown and the need for re-doing a joint replacement. Redoing her joint replacement is much more difficult than the original procedure, and is to be avoided if possible. I have had one patient least whose recovery from hip replacement surgery was dramatically short and painless because she had been using her PEMF system for at least a year prior to the surgery. Her doctors and physical therapists were amazed at how quickly she recovered. This almost never happens with a hip replacement. Again, my point is that we never know what kind of benefits can happen with any given individual, even though not necessarily all of our objectives are met when purchasing the PEMF system.

I consider pulsed magnetic therapy to be a lifetime health care tool. Therefore, the way the system purchased can be used will obviously vary over time depending on circumstances. No matter what, we all need health maintenance, and therefore magnetic therapy should be a component of daily health management.

5. Proper placements of magnetic therapy devices
The usual placement of applicators is to the place of pain or discomfort. Often however, the pain is actually generated in another part of the body. For example, low back problems can be referred down to the knee or foot. Knee problems can be referred to the foot. Hip problems can be referred to the knee. Shoulder problems can be referred to the elbow or wrist/hand. Spasticity of the lower extremities is caused by a problem in the spinal cord. And so on. If it is known that the lesion is directly in the tissue experiencing the pain, then it is appropriate to apply the PEMF applicator to that spot. There is never any harm and placing it higher up, particularly the spinal cord because all sensory traffic from the lower extremities travels to the brain through the spinal cord. The brain will perceive the pain and send a signal back to the extremity or location of the pain. So, treating the spinal cord above the level of the problem can be very helpful. For example, if the problem is in the arm then it may be useful to also apply treatment to the neck. A problem in the lower extremities can be additionally helped by applying the applicator to the lumbar spine area, to get the lumbar spinal cord.

Not only is it important to place the applicators in the right locations, but also it may not be as useful to treat the entire body expecting specific areas to receive the same level of benefit. As mentioned above, to lie on your back will not necessarily help the front of your chest, because the field intensity may not be strong enough to treat the chest. So an application may be needed to the back as well as the front of the chest, in this case. Some magnetic systems allow two applicators to be used simultaneously on opposite sides of the body part. This often allows higher field intensity to be generated in the tissues between them, which I call a magnetic sandwich. Some applicators can actually be folded into a tube which also increases the intensity the field in the body part inside the tube. This can also be accomplished with a whole body pad turned sideways and wrapped around part of the body.

Depending on the magnetic system, a pillow applicator may be of higher intensity than a whole body pad. Even if not, a pillow applicator can be applied for much longer periods of time without the risk of over stimulating the body, as would happen with extended treatments with the whole body pad. Generally, tissues in body cavities, such as the abdomen, the chest and the skull, are more sensitive and may be easily overstimulated in some individuals. In this case, lower intensities and shorter periods of time may be necessary to reduce over-stimulation.

It is likely that different body parts need different periods of time of treatment, depending on the level of dysfunction, discussed above. Often, acute problems need less time than chronic problems. So, treatment times will need to be adjusted based on the circumstances.

6. Getting support from your therapist or health care professional
While often, a purchased PEMF system can be used out-of-the-box following the instruction manual, it may be possible that support is required from somebody who is well-informed about clinical conditions and understanding the technology being applied. Obviously, if the treatment is not going well or producing acceptable results, professional support may be necessary. Most medical personnel will have some significant degree of knowledge about clinical conditions but have very little understanding of PEMF technology and so they may not be able to provide useful advice.

So Tell your doctor about the magnetic therapy resources on Almagia.com!

7. Having adequate nutritional support
I instruct patients that you can’t build a house without bricks and mortar. It is well known in medicine that wounds won’t heal without adequate nutritional support. In fact, wounds will often stall or breakdown and become complicated because the nutritional state is inadequate. I know surgeons will not operate until patients have been on an adequate nutritional program for several months before elective surgery. We often run into trouble doing emergency surgery because the condition of the body is not up to the stress of the surgery and won’t support adequate recovery afterwards. So, for PEMF therapies to work best, individuals need to be on decent diets and using a reasonable number of supplements. At the very least most of us should be taking adequate levels of vitamin D3, omega-3 fatty acids, and a broad spectrum multidose, multivitamin. It may be desirable to get a consultation with a natural medicine clinician or nutritionist to get set up on appropriate nutritional program. Many people using PEMFs need extra magnesium. Some individuals need support with melatonin as well. A high carbohydrate, high fried foods diet, or what might be called the standard American diet (SAD) does not adequately support tissues to achieve the best results with PEMF therapies. Additionally, PEMFs will work better when the bodies adequately hydrated. It is often recommended that individuals should be drinking about half their body weight in ounces. For example, a 160 pound person may need about 80 ounces of fluid per day. Most of us should be getting minimally, about 64 ounces per day. Caffeinated drinks do not count as fluids since we tend to lose as much as we put in.

8. Effects of medications
Some medications are very challenging to the bodies energy systems. Some of them, particularly the antidepressants, neuroleptics and sedatives may change the way the body perceives pain signals. They may in fact the blunt some of the pain reduction benefit of PEMFs. I would never suggest that somebody should stop their medications without medical consultation. I raise this point only to inform you that occasionally pain reduction is not a successful. This is not to say that all the other benefits of PEMFs in healing and regeneration would not be happening. This only relates to the sensation or perception of pain. On the other hand, is not infrequent that the same medications may actually be improved in their results with reduction of pain symptoms by the simultaneous use of PEMFs and the medications. My experience indicates that medications and nutrients are absorbed better in the body with the use of PEMFs. On occasion, it is possible to reduce medications once PEMFs have been used. Again, this should be done with medical guidance.

9. Toxicity and sensitivity
Infrequently, some individuals are very sensitive to PEMFs and experience increased discomfort or other unpleasant symptoms. These individuals may have a condition called electrohypersensitivity.

When this happens, PEMF therapy would have to be used “low and slow.” We would need to use lower intensities, often the lowest possible on the system, and only extremely gradually increase the intensities and the time per treatment. Clearly, in this situation benefits may be more difficult to achieve because the appropriate and necessary intensities in time are not possible. Still, results can be dramatic given the opportunity with this treatment. Consultation with a clinician experienced in the use of PEMFs in this setting may be necessary. Most of these individuals need to be on a significant supplement and nutrition program to achieve the best results.

PEMFs can open cells and cell membranes to the point of unloading toxins stored in the tissues of the body. This type of response is in the long run a desirable action. However it may be unpleasant and will have to be managed by a clinician experienced in doing detoxification. The length of detoxification will vary from individual to individual. Rarely will PEMF therapy have to be stopped, whether temporarily or indefinitely while this is happening. Those individuals will multiple chemical sensitivity PEMF therapy may well be intolerable and may never be able to be used even in the most gentle fashion, at least until major detoxification can be achieved.

10. Psychological issues
Research at Hopkins, in their pain management program, found that some individuals with chronic pain have certain personality traits, that result in very poor treatment outcomes. These individuals often experience negative reactions to even placebo magnetic field devices. And when they are followed over time, some even complain that their problems continue to be worse due to the placebo treatment. In this situation it is not possible to ever please these individuals and PEMF therapy is not an appropriate treatment modality. Psychological counseling is necessary to help with any pain issues in this situation.

11. Wrong magnetic therapy device
In the final circumstance, if results are not being achieved as desired, it is possible that the wrong device has been selected. It is often difficult to know in the first month or two months of use whether the device is appropriate or not. Since many health problems for which PEMFs are being used are stubborn and chronic, it may take 3 to 6 months to see desirable results. Usually, people see some degree of change even in the first month. If the treatment program is too gentle with too little time applied, then results may not be seen even in the first month. It would be easier to say with certainty that the device is inadequate after at least three months of intensive and proper use. When this happens, it is usually a matter of having inadequate field intensities. In this case, a much stronger device may be needed. My experience is that this is an uncommon situation.

Understanding and managing the above scenarios would usually lead to positive results with PEMF therapies. Adjustments in the treatment program will likely be necessary over time to address various problems in the body and also to properly handle the needs of any specific body area.

Do you have questions? – Ask a Question

Find out more about Almagia’s magnetic therapy devices

Osteonecrosis of the femoral head is the end point of a disease process that results in progressive collapse of the femoral head followed by destruction of the hip joint. It has been recognized as a side effect of the longer term, high-dose steroids used to treat diseases such as Acute Respiratory Syndrome (SARS), Acquired Immunodeficiency Syndrome (AIDS) and Systemic Lupus Erythematosus (SLE), rheumatoid arthritis, inflammatory bowel disease, such as ulcerative colitis and Crohn’s disease, among others. High-dose corticosteroid administration is considered to be the most common risk factor for osteonecrosis. Dosages typically considered to be associated with the disease are > 2 g of prednisone, or its equivalent, over within a period of two to three months. Lower dosages are not typically related to osteonecrosis of the femoral head. With the progression of osteonecrosis, both the bone and cartilage femur part of the hip are deformed, which ultimately leads to collapse of the load-bearing area of the femoral head. Once osteonecrosis collapses the femoral head, most patients require surgical treatment. Several surgical treatments have been established to prevent collapse, such as core decompression, osteotomy,  vascularized or bone grafting  and hip replacement. The results of these procedures are not always successful and may create serious complications, often leaving these individuals with significant hip damage,  disability and misery. Therefore, preventing osteonecrosis would be an ideal strategy for this disease, but there is no established prophylactic measure.

It is well documented that pulsed electromagnetic fields (PEMF) are useful for enhancing bone repair in nonunion fractures and related bone-healing problems. In addition, it has already been found useful for the treatment of osteonecrosis of the femoral head, at the early stage, The optimal protocol for PEMF is unknown. Various biological factors are involved in bone remodeling, especially bone cell (osteoblast) growth factors. There is some indication that lipids may block nutrient vessels thus leading to blockages of the blood vessels supplying the hip. This study was done on rats to see if PEMFs could prevent the osteonecrosis commonly seen with the use of high-dose steroids. The PEMF devices used consisted of a signal generator and a pair of 40-cm diameter coils placed on either side of the cage of the animals. The signal was repetitive, single, square-wave pulses with pulse duration of 4.5 ms and frequency of 15 Hz. The magnetic field increased from 0 to 12 G in 4.5 ms and then decreased back to 0 in 20 ms, for 4 h/day. There were two control groups. One received IV lipids and steroids (MPSL), similar to the PEMF group, and the other was a neutral control (PS). This chart shows the progression of osteonecrosis in each of the study groups. It can be seen that the MPSL group all developed osteo necrosis by the fourth week. Some of them resolved in the subsequent four weeks after the last dose of steroids with the final percent being 75% versus only 29% in the PEMF treated group. This is a very large and clinically significant difference.

 Table 1: Incidence of osteonecrosis of the femur (%)

 *P < 0.05 versus MPSL group.

PEMF stimulation has been used successfully to treat nonunion fractures and osteonecrosis or aseptic necrosis of the head of the femur, but relatively little is known about its effects on preventing steroid-induced osteonecrosis. Furthermore, the mechanisms and the optimal protocol for PEMF stimulation for the prevention of steroid-induced osteonecrosis are unclear. There are some differences in osteonecrosis in rats as compared to humans. For example, osteonecrosis often leads to femoral head collapse in humans but not in rats, based on the differences in anatomy in adult rats versus adult humans. Also, the metabolic rates are higher in rats than in humans, so osteonecrosis can be seen in rats within one w Herries is red or really important study eek after steroid treatment. Steroid-induced osteonecrosis can be prevented by anticoagulants or lipid-lowering agents, with reductions in osteonecrosis that range from only 30% to 40%. This study found a 60% reduction and no side effects. Therefore, PEMF stimulation is a safe and effective treatment for preeither red or really important study venting osteonecrosis. They also found that the incidence of osteonecrosis in the usual high steroid group displayed progression over the course of treatment, while that in the PEMF group did not. PEMF stimulation may prevent osteonecrosis by decreasing serum lipid levels, increasing TGF-b1 and RNA. TGF-b1 is involved in many aspects of skeletal development and regulation, such as fracture repair and bone regeneration, as it can promote the proliferation and differentiation of osteoblasts, that is, bone building cells. The results of this study showed that the mRNA and protein expression of TGF-b1 was suppressed in the steroids group but increased in the PEMF group.

PEMF stimulation has been used successfully to treat nonunion fractures and osteonecrosis or aseptic necrosis of the head of the femur, but relatively little is known about its effects on preventing steroid-induced osteonecrosis. Furthermore, the mechanisms and the optimal protocol for PEMF stimulation for the prevention of steroid-induced osteonecrosis are unclear. There are some differences in osteonecrosis in rats as compared to humans. For example, osteonecrosis often leads to femoral head collapse in humans but not in rats, based on the differences in anatomy in adult rats versus adult humans. Also, the metabolic rates are higher in rats than in humans, so osteonecrosis can be seen in rats within one week after steroid treatment. Steroid-induced osteonecrosis can be prevented by anticoagulants or lipid-lowering agents, with reductions in osteonecrosis that range from only 30% to 40%. This study found a 60% reduction and no side effects. Therefore, PEMF stimulation is a safe and effective treatment for preventing osteonecrosis. They also found that the incidence of osteonecrosis in the usual high steroid group displayed progression over the course of treatment, while that in the PEMF group did not. PEMF stimulation may prevent osteonecrosis by decreasing serum lipid levels, increasing TGF-b1 and RNA. TGF-b1 is involved in many aspects of skeletal development and regulation, such as fracture repair and bone regeneration, as it can promote the proliferation and differentiation of osteoblasts. The results of this study showed that the mRNA and protein expression of TGF-b1 was suppressed in the steroids group but increased in the PEMF group.

As a preventive therapy, PEMF could be used in combination with corticosteroid for treatment of many clinical conditions, such as AIDS and SLE, which require high-dose corticosteroid treatment. Daily treatment with PEMFs of 4 or more hours appears to be necessary, and it may be preferable to do the treatment at night. Therefore, a PEMF system is necessary that can run for hours at a time and could easily be focused on the hips. While PEMF stimulation can prevent steroid-induced osteonecrosis in rats, it is not an unreasonable assumption that similar use of PEMFs could well be very helpful with humans too. This should be a very important and useful prevention strategy in any people needing higher dose steroids, likely to equal or exceed 2 g total in a given course of treatment. Someone on 60 mg per day of prednisone would exceed this limit in just about one month. At 40 mg per day the dose would be exceeded in about two months. So, anyone expected to need at least this much steroid in their course of treatment needs to have a prevention strategy in place. The risk may further be exaggerated when multiple courses of steroids are used in relatively short periods of time. A prevention strategy using PEMF stimulation could reduce a very large, and unnecessary, toll of suffering. It is simple and inexpensive with virtually no side effects or risk. Waiting to see that there are osteonecrosis-like effects already happening to the hips may not produce as effective results. The extent to which PEMFs may help once osteonecrosis has begun is unknown, and is not as likely to be as effective. Therefore a PEMF prevention strategy should be begun at the initiation of any course of high-dose steroid therapy.

From Pulsed electromagnetic fields stimulation prevents steroid-induced osteonecrosis in rats.

Ding S, Peng H, Fang HS, Zhou JL, Wang Z. BMC Musculoskelet Disord. 2011 Sep 29;12:215.

Pulsed electromagnetic fields (PEMFs) have been used to treat almost every conceivable human illness or malady, including many inflammatory diseases such as arthritis or psoriasis.

PEMF therapy has been associated with pain reduction, and accelerated healing. PEMFs exert these effects by regulating processes involving inflammation and autoimmune diseases, among other biologic actions.

What is Inflammation?
Inflammation is a cascade of physiologic processes instigated by the body to repair cellular damage in tissues with good blood supply and to restore the tissue to its normal function.

Characteristic signs and symptoms that accompany inflammation include:
- redness generated by increased blood flow,
- heat generated by the metabolism of leukocytes and macrophages recruited to the damaged site,
- swelling due to edema, and
- pain caused by the production of pro-inflammatory prostaglandins.

Inflammation is the net result of a cascade of biologic processes that is generated and supported by the interaction of a number of immune cell types, including lymphocytes, macrophages and neutrophils, with other cell types such as the fibroblasts, endothelial cells and vascular smooth muscle cells playing a regulatory role in the cascade.

Acute vs. chronic inflammation
While inflammation is a necessary and beneficial process, its intensity during the initial acute phase can be abnormally exaggerated, and often persists longer than necessary, developing into chronic inflammation.

Chronic inflammation is associated with dysfunction of one or more parts of the immune system and leads to the ongoing tissue damage found in diseases like tendinitis, arthritis or psoriasis. Chronic inflammation is also a cause of cancer and Alzheimer’s disease, among many other disease conditions.

Mechanics of inflammation
The various cell types and metabolic pathways that generate inflammation provide numerous targets for therapies aimed at controlling inflammation in the acute phase and in preventing progression to chronic inflammation. Inflammation can be initiated by many causes, and knowing and understanding the nature of the cause is important in designing therapeutic approaches.

In bacterial infections, early infiltration of the affected tissues by polymorphonuclear neutrophils (PMNs), a type of white blood cell, is followed by the arrival of T cells, an event that is required to kill bacteria. In this circumstance, eliminating T cells can delay or stop healing. In trauma-induced injury, T cells are less important for healing tissue damage, and may be harmful if present for long periods. In this case early elimination of T cells in the acute phase of inflammation could minimize the unwanted effects of inflammation, accelerate healing, and reduce the risk of chronic inflammatory disease. In chronic inflammatory diseases such as rheumatoid arthritis, psoriasis, and chronic tendinitis, persistence of the disease state depends on the presence of T cells. Here, removing T cells would be a favorable approach of therapy for these and similar chronic conditions.

T cells are a major regulator of the inflammatory cascade. Research has shown that PEMFs can induce the appropriate death of T lymphocytes, by actions on T cell membranes and key enzymes in cells. For example, PEMFs have been found to affect ion flow through specific cell membrane channels, including those for sodium, potassium and calcium, that positively affect these enzymes. These appropriate effects help with reducing chronic inflammation.

Homeostasis and cells out of balance
Normal cells are not usually impacted by magnetic fields. Compromised cells, called meta-stable cells, are more likely to be impacted. This means that PEMFs have more impact in circumstances where there is imbalance in tissues or cells, ie, where there is pathology or chronic inflammation. Where homeostasis in the body is robust, PEMFs, especially weaker PEMFs, are unlikely to have effects. For example, activation of the T cell receptor, such as happens with PPEMFs, also activates various processes in the cell that within five minutes after removing the activating signal, these activated processes return to normal levels.

Reduction of inflammation by PEMFs
Significant changes occur in other white blood cells called lymphocytes, from both low intensity, low-frequency PEMF’s and even DC/permanent magnetic fields. PEMFs interact with cellular systems in often unexpected ways. This means that increasing frequency and or intensity does not always produce a one-to-one change in reaction intensity.

PEMF’s inhibit growth and the natural death of unwanted lymphocytes that decreases inflammation. The EMF inhibition of lymphocytes and then inflammatory processes appears to be most obvious 48 and 72 hours after EMF treatment and then the EMF effect seems to disappear. This indicates that the effects of PEMFs can work well with other natural treatments.

EMF use for inflammation needs to be optimized so that exposure will lead to long-lasting, therapeutically relevant outcomes. Pulse-burst-modulated higher frequency fields seem to be much more effective than other frequency signals, and therefore produce improved therapeutic outcomes. While particular types of signals may be most effective, a positive response is often seen to various kinds of magnetic stimuli. There appear to be similar effects on lymphocytes using pulsed bone healing fields, versus sinusoidal power line frequency fields.

Pulsed PEMFs with intensities from 5-25 MilliTesla had no effects on normal T cells. This means there is no apparent damage to normal lymphocytes. Inflammatory T cells produce interleukin-2 (IL-2), which stimulates growth of T cells. When IL-2 levels are high enough, it increases desired early elimination of these chronic inflammatory cells. Cells exposed to pulsed PEMFs can make up to a threefold increase in IL-2.

There appear to be EMF intensity windows, but these have not been well defined. Frequency windows have been found to vary across different types of tissue cells in the body. The frequency ranges appear to be quite narrow for bone cells. For lymphocytes the frequency windows seem to be broader. Even 5-100 hertz, 0.15 mT signals modulate calcium flux in lymphocytes, 50 Hz PEMFs having the greatest effect. Frequency fields, combined with parallel static magnetic fields have also been found to have action.

It is important to know that PEMFs affect all lymphocytes, including B cells and T cells and other human lymphoid cell lines.

Summary
EMF therapy specifically targets cells that are meta-stable as a consequence of disease or other ongoing therapies. Thus, PEMF’s can be an important cellular therapy in many diseases, including cancer, psoriasis, wound healing, and bacterial infections because of their effects on reducing chronic inflammation. It is important that normal homeostatically stable cells are not harmed by PEMF’s, allowing other treatments to be more effective without proportional increases in side effects. In chronic inflammatory diseases, cells are characteristically maintained in meta-stable states, as a consequence of cytokine secretions and other stressors associated with the disease. In these cases, PEMF’s can work as a stand-alone anti-inflammatory therapy. Even weak, low-frequency PEMF’s induce apoptosis in activated T cells, thereby reducing chronic inflammation without negatively affecting acute inflammation. Quoted from Dr. W. Pawluk

Lyn M Sibley   BSc MHA, Researcher

BC Office of Health Technology Assessment Centre for Health Services & Policy Research

University of British Columbia

Carolyn J Green   BHSc (PT)  MSc, Research Co-ordinator

BC Office of Health Technology Assessment

University of British Columbia

Craig W Martin   MD MHSc, Senior Medical Advisor

Workers’ Compensation Board of British Columbia

Ken Bassett   MD PhD, Senior Medical Consultant

BC Office of Health Technology Assessment

Centre for Health Services & Policy Research

University of British Columbia

Arminée Kazanjian    Dr Soc, Principal Investigator

BC Office of Health Technology Assessment

Centre for Health Services & Policy Research

University of British Columbia

DECEMBER  2001

•

BC Office of Health Technology Assessment

Centre for Health Services and Policy Research University of British Columbia

429 – 2194 Health Sciences Mall

Vancouver  BC

Canada   V6T 1Z3

Tel: (604) 822-4810

Fax: (604) 822-5690 bcohta@chspr.ubc.ca www.chspr.ubc.ca

National Library of Canada Cataloguing in Publication Data

Main entry under title:

Pulsed signal therapy for musculoskeletal conditions

© 2001 by British Columbia Office of Health Technology Assessment, The University of British Columbia. Permission is granted to reproduce all or any portion of this report, providing acknowledgement is given to the authors.

ii

FOREWORD

The British Columbia Office of Health Technology Assessment (BCOHTA) was established on December 1, 1990 by a grant from the Province to the University of British Columbia, to promote and encourage the use of assessment research in policy, planning and utilization decisions by government, health care executives, and practitioners. The Office does not participate in policy development for a requesting agency; its role is confined to appraisal of the scientific evidence.

Assessments are performed in response to requests from the public sector such as hospitals, physicians, professional associations, health regions, government; private sector groups such as manufacturers; and members of the general public. One or more of the following criteria are used to determine the priority of an assessment and the level of analysis: (1) the number of users and potential change in quality of life; (2) the acquisition and operating costs to the health care system; (3) the potential to influence provider and consumer behaviour as a result of a review; and (4) the availability of accurate information and appropriate research skills.

Health Technology Assessment projects are conducted by faculty and staff (including medical consultants) who are expert in systematic review methodology. Electronic bibliographic databases and fugitive literature (that is, literature not indexed or distributed publicly) are searched using predefined inclusion and exclusion criteria based on a specific search strategy. The critical appraisal of retrieved evidence includes the formulation of logical and defensible conclusions about the technology under study.

Reports are reviewed internally, and then sent for external review to experts from a variety of academic or clinical disciplines. Comments and suggestions are considered before a final document is produced. Reports are available for public distribution from the Office, by request or inclusion on the mailing list; or from the Centre website.

The strength of BCOHTA’s method of systematic review lies in the process of explicitly detailing the methodology and criteria used to produce recommendations, which are based solely on the research evidence. This transparent and reproducible assessment process allows other investigators to review the evidence independently and objectively.

Arminée Kazanjian    Dr Soc

Principal Investigator, BCOHTA

iii

ACKNOWLEDGEMENTS

The observations and suggestions of the following reviewers have been extremely valuable in the preparation of this report, and their contributions are most gratefully acknowledged. Participation in the review process does not imply endorsement, however, and the British Columbia Office of Health Technology Assessment takes full responsibility for the views expressed herein.

Internal Review

Carol Cole RN MSc

Researcher

Centre for Health Services & Policy Research

University of British Columbia

Vancouver  British Columbia

Canada

External Review

Hugh Anton MD FRCPC

Head, Division of Physical Medicine & Rehabilitation

GF Strong Rehabilitation Centre

Vancouver Hospital & Health Sciences Centre

Vancouver  British Columbia

Canada

Dr Alicia Framarin MD MSc

Chercheure

Agence d’évaluation de technologies et des modes d’intervention en santé

Montréal  Québec

Canada

Allan Kozlowski

Physiotherapist

Workers’ Compensation Board of BC

Rehabilitation Centre, Clinical Services

Lloyd Oppel   BSc MD CCFP (EM)

Chair, Alternative Therapy Evaluation Committee

Vancouver Hospital & Health Sciences Centre

Vancouver  British Columbia

Canada

iv

v

APPENDICES

Appendix A      Prioritizing criteria applicable to Pulsed Signal Therapy……………………… 19

Appendix B      Patents…………………………………………………………………………………………. 20

Appendix C     Search strategy…………………………………………………………………………….. 22

Appendix D     BCOHTA intervention study appraisal form……………………………………… 24

Appendix E      Excluded articles……………………………………………………………………………. 26

Appendix F      Technical specifications of devices in RCTs…………………………………….. 28

Appendix G     Randomized controlled trials of non-PST PEME devices…………………… 30

BIBLIOGRAPHY…………………………………………………………………………………………………… 32

REFERENCES……………………………………………………………………………………………………… 37

FIGURES & TABLE

Figure 1            Pulsed Electromagnetic Field Devices………………………………………………. 8

Figure 2            Pulsed Signal Therapy with alternating rectangular pulses…………………… 8

Table 1             Summary of secondary outcomes – Menkes et al (1998)…………………. 15

vi

EXECUTIVE    SUMMARY

Findings

This systematic review examined whether pulsed signal therapy (PST) provides a significant effectiveness and safety therapeutic advantage over other musculoskeletal-injury treatment devices that use magnetic pulses to induce electrical current in injured tissue.

There are no published controlled, clinical trials showing that PST provides a clinical advantage versus placebo or other pulsed electromagnetic energy devices. The one small, unpublished randomized controlled trial of PST that could be located provides no valid evidence that PST is more effective than placebo at treating the symptoms of osteoarthritis of the neck or knee.

Pulsed Signal Therapy

PST is a specific form among a class of devices which use pulsed electromagnetic energy (PEME) to induce electrical current which is claimed to promote healing in injured or diseased tissues.

PEME devices share several basic features deriving from the transmission of electromagnetic energy, including intermittent electrical current, non-contact with the skin, and having no detectable thermal effect.

PEME has been used clinically in Europe, Canada, and the United States. Currently, the use of PST in North America is limited to facilities in Mexico (Tijuana), and Canada (Vancouver). In April 2000, PST was approved (without review of effectiveness evidence) by Therapeutic Products Directorate of Health Canada Health Product and Food Branch. The extent to which it has subsequently gained acceptance is unknown.

The PST Centers state that PST is distinct from pulsed electromagnetic field therapy (PEMF),

a specific type of PEME therapy. According to the Centers, PST has pulses of variable intensity and frequency, while the pulses of PEMF are of constant intensity and frequency. It is not known whether these differences produce different clinical effects. The PST Centers make claims about the difference in favourable clinical outcomes from PST versus other PEME devices, and the cost of the services they provide is based on this assumption of difference.

Pulsed Signal Therapy in musculoskeletal conditions                                                                                vii

BC Office of Health Technology Assessment

Methodology

This study systematically reviewed the literature for randomized controlled trials that met the

following criteria:

• assessment of individuals with non-fracture musculoskeletal conditions;

• application of Pulsed Signal Therapy (PST) for the purpose of effecting health benefits;

• measurement of the health outcome pertaining to the effect of pulsed or oscillating magnetic fields; and

• comparison of PST with an alternative PEME device.

An electronic search of the literature was undertaken, aimed at ensuring comprehensive coverage of both traditional and ‘grey’ literature. A fugitive literature search was undertaken to identify documents not referenced in technical reports, unpublished material, conference proceedings, theses, as well as government papers and policy documents not controlled by commercial publishers.

All articles which met the inclusion/exclusion criteria were critically analysed by two researchers. Any discrepancies between the reviewers were resolved through discussion.

Results

Thirty-nine articles were identified and retrieved. Twelve of these were randomized controlled trials of therapy with a pulsed electromagnetic energy device. Of these, eleven trials were excluded because they were not studies of PST, but of other PEME devices. Only one of the identified trials was an assessment of PST. This trial was placebo-controlled and not a comparison with any other form of PEME.

The one included trial was an unpublished report of a study conducted in France by Menkes et al in 1998. The sample used in this trial was small, and the analysis performed was without

adjustment for multiple comparisons examining significant outcomes. The reviewers agree with the study authors that no valid conclusions can be drawn from this trial. Larger, longer, and better-conducted RCTs are needed to establish effectiveness of PST versus placebo.

viii                                                                        Pulsed Signal Therapy in musculoskeletal conditions

BC Office of Health Technology Assessment

1      INTRODUCTION

The Workers’ Compensation Board (WCB)* Technology Assessment Committee^† in collaboration with the BC Office of Health Technology Assessment (BCOHTA) examined the effectiveness and safety evidence regarding pulsed signal therapy (PST) in the treatment of non-fracture musculoskeletal conditions. PST is a specific form among a class of devices which use pulsed electromagnetic energy to induce electrical current which is claimed to promote healing in injured or diseased tissues. Induction of electrical current means that the device has no electrodes in direct contact with the patient. Affected tissue is instead situated within an electrical ‘inducing’ magnetic field.

Some types of electromagnetic inducing technologies are currently used in British Columbia. Under the provincial health insurance plan, they are all paid for as part of a general therapy code. The relevant hospital department or private practitioner is reimbursed for the session, regardless of the technique or technology used. A hospital physiotherapy department may,

for example, use a form of electromagnetic inducing device with or without other technologies such as ultrasound, heat therapy, or massage, in the course of a treatment session. A series

of 10 treatment sessions with a physiotherapist currently costs the WCB approximately $305 CDN.

The WCB has received requests from the Vancouver Certified Pulsed Signal Therapy Center to pay specifically for PST treatment within the Center. The WCB Technology Assessment Committee selected this modality as appropriate for priority review, primarily because this class of devices could potentially be used in many treatment programs for work-place injuries. The Committee criteria and their application to PST are summarized in Appendix A.

*      The Workers’ Compensation Board (WCB) of British Columbia is the principal payment agency for work-related injuries in the province. The WCB funds rehabilitation and a range of other services, as well as providing compensation and other health care benefits.

†      In collaboration with BCOHTA, the WCB recently established a Technology Assessment Committee, mandated to determine the effectiveness, safety, and cost of new and improved technologies used for diagnosis and treatment of work-related injuries in the province.

A course of treatment at the PST Center costs $2,000 CDN, and includes “nine one-hour treatment sessions, … consultation and evaluation by the physician, and all associated medical examinations.” ¹ WCB administrators consequently asked whether clinical evidence of patient benefit was sufficient to justify this expenditure.

In consequence, this systematic review does not examine whether PST or similar devices provide a therapeutic advantage versus placebo or alternate forms of technology, such as ultrasound. Instead, the review focuses specifically on PST, and follows a relative effectiveness and safety framework, that is, consideration of whether scientific evidence supports PST versus other devices in the same therapeutic class. The question of benefit includes two components: i) How does PST differ from less expensive alternatives; and

ii) which patients have been shown to benefit?

Research question

Having regard to these component issues, the principal question addressed in the systematic review was formulated as follows:

Does Pulsed Signal Therapy (PST) provide a significant effectiveness and safety therapeutic advantage over other musculoskeletal-injury treatment devices that use magnetic pulses to induce electrical current in injured tissue?

3               BACKGROUND

3.1         Pulsed Electromagnetic Energy devices

A number of different devices have been used to expose injured or diseased parts of the body to pulsed electromagnetic energy. These devices have numerous names, including: ‘pulsed diathermy’, ‘pulsed electromagnetic field’, ‘pulsed short-wave’, ‘pulsed high-frequency electromagnetic energy’, ‘Diapulse’, ‘oscillating magnetic fields’, and ‘pulsed signal therapy’. In this report, all devices in this class are referred to as ‘pulsed electromagnetic energy’ (PEME) devices.

PEME devices share several basic features deriving from the transmission of electromagnetic energy, including intermittent electrical current, non-contact with the skin, and having no detectable thermal effect.

PEME devices are not considered complex electrical equipment, nor are they costly to construct. The apparatus usually employs a cylindrical coil of wire, housed so as to surround whatever body part is being targetted. For example, the technology studied in two randomized controlled trials, pulsed electromagnetic field (PEMF), is described by authors as a device that “consisted of 3 integrated components, a magnetic field generator, an electronic interface, and a segmented single toroid coil with annular windings that produced pulsed DC elliptical magnetic fields. The system used a coil current of <2 A with 120 V.” ²

An electrical engineer ³ consulted for this report estimated that it would take a suitably-qualified person a few hours to assemble a PEMF device, constructed from standard components. If a pre-assembled magnetic coil were not readily available, a suitable coil could be wound by hand.

A variable-frequency electrical-wave generator of requisite accuracy and variability range would be the most expensive component. Since the generator signal is likely to be of insufficient power rating to drive the electromagnet, an electrical amplifier would also be required. Altogether, the estimated total cost of materials is likely to be less than $400.00.³

Pulsed Signal Therapy in musculoskeletal conditions2 BC Office of Health Technology Assessment

3.2      Mechanism of action

Several theories have been advanced to explain how PEME promotes healing and relieves pain:

• “ … the electromagnetic energy ‘stirs’ ions, molecules, membranes and perhaps cells thus

speeding up phagocytic activity, enzymatic activity, transport across membranes and so forth.” ⁴ (p267)

• “Some depolarization of the cell membrane is often associated with cell dysfunction and electrical potentials develop during wound healing. The membrane potential is also involved in the control of cell division and hence in the control of growth, development and repair. It has been proposed that the electromagnetic field could influence the flow

of the ions through the membrane and therefore restore the normal cell potential in some damaged cell.” ⁴ (p267)

• “ … cells are capable of absorbing energy from oscillating electrical fields of defined

frequencies and amplitudes, and making use of this energy for chemical work.” ⁴ (p267)

• “ … pulsed ultrasound has been shown to accelerate healing at different rates with different intensities and pulse lengths. It is reasonable to suppose that both electromagnetic and mechanical pulsing have similar effects at a subcellular level, a piezoelectric link. Piezoelectric effects are known to occur in the tissue, for example mechanical stress on bone leads to a redistribution of charges. It is argued that the importance of pulsing may lie in the fact that brief pulses of high intensity will not

necessarily have the same effect as an identical quantity of energy applied continuously.”

⁴ (p267)

• “Beneficial effects are simply due to the recognized effects of very mild heating … At microscopic level, ‘heat’ is simply the kinetic energy of small particles and is likely to

vary from place to place. Thus, the addition of small amounts of energy to the tissues could well increase local particulate motion.” ⁴ (p267)

• Studies of electrical phenomena in cartilage suggests the phenomenon may stimulate chondrocyte synthesis of matrix components. ⁵

• Pulsed electromagnetic energy therapy is “a form of therapy that involves directing a

series of magnetic pulses through injured tissue. Each magnetic pulse induces a tiny electrical signal that stimulates cellular repair.” ⁶

Such theories, whatever their merit, are not immediately pertinent for present purposes, since it is the therapeutic effect of these devices which is at issue. Uncertainty concerning the mechanism of action would not undermine any outcome benefit found by properly conducted clinical trials.

3Pulsed Signal Therapy in musculoskeletal conditions

BC Office of Health Technology Assessment

3.3      Clinical conditions

Pulsed electromagnetic energy (PEME) was initially used in the early 1970s for the treatment of

soft tissue injuries,⁵  and in the 1980s to promote skin ulcer healing.⁷    PEME is most accepted as

a means of promoting bone and cartilage repair, particularly in the event of delayed healing such as non-union fractures, but the technology has also been used in the treatment of the following non-fracture musculoskeletal conditions:

• avascular necrosis of hips ^11,12

• Legg-Perthes’ disease ¹³

PST Centers’ focus is on the treatment of non-fracture musculoskeletal conditions.

PEME has been used clinically in Europe, Canada, and the United States.^2,91011 Currently, the use of PST in North America is limited to facilities in Mexico (Tijuana), and Canada (Vancouver). These are listed on the PST Centers’ website, which also offers to provide requesters with the location of facilities operating outside North America.¹⁴ PST has had regulatory approval for use in Canada since April 2000. The extent to which it has gained acceptance is unknown.

3.4      Identifying the technology

3.4.1     Licences

Health Canada, Health Protection Branch

PST has received approval from the Therapeutic Products Directorate (Medical Devices Bureau), Health Canada, as a Class II Device. The licence is listed as Pulsed Signal Therapy System with the manufacturer Bio-Magnetic Therapy Systems GMBH, licence # 19291.

Pulsed Signal Therapy in musculoskeletal conditions4 BC Office of Health Technology Assessment

In order to receive a licence for a medical device in Canada, the manufacturer must attest to have

evidence that the device “shall be effective for the medical conditions, purposes and uses for

which it is manufactured, sold or represented.” ¹⁵    The manufacturer need not actually provide

the effectiveness evidence, since it is not assessed by the regulatory body.

US Food and Drug Administration

The website of the Pulsed Signal Therapy Centers states that the “technology is available in most

important industrialized countries in the world but is not yet approved by the FDA [United

States’ Food and Drug Administration] or available in the United States.” ¹⁶

Under the FDA guidelines, PST would be rated as a Class III device.

“Pre-market approval is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Not all Class III devices require an approved pre-market approval application to be marketed. Class III devices which are equivalent to devices legally marketed before May 28, 1976 may be marketed through the pre-market notification [510(k)] process until the FDA has published a requirement for manufacturers of that generic type of device to submit pre-market approval data.” ¹⁷

It is not clear from the available information whether PST would require FDA ‘pre-market

approval’ or ‘pre-market notification’.  The FDA’s Center for Devices and Radiological Health

(CDRH) states:

“Both domestic and foreign manufacturers must list their devices with FDA if the devices are in commercial distribution in the United States … Neither registration nor listing constitutes FDA clearance or approval for marketing or commercial distribution in the U.S. Unless the device is exempt, a pre-market notification submission [510(k)] or a premarket approval application (PMA) is required before commercial distribution commences. Registration of a device establishment or submission of device listing does not in any way denote approval of the establishment or its products by FDA.” ¹⁸

A search of the CDRH database found a registration listing for a “PST System Model Mark II”

with the company Bio-magnetic Therapy Systems, Inc.  The device is not found in either the

‘pre-market approval’ or ‘pre-market notification’ databases, however, indicating that to date,

PST does not have FDA approval.

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3.4.2     Patents

Types of PST devices are patented in both Canada and the United States.   A detailed description

of the identified patents is provided in Appendix B.

There is no Canadian patent for any device specifically named “pulsed signal therapy”, but two

patents are held by Bio-magnetic Therapy Systems, Inc. for devices that appear to be PST

devices. The technology in the two patents (Appendix B) seems identical, distinguished only by mode of administration. The mode of administration in the first (#2,082,170 – Magnetic field therapy and apparatus) is a table or bed on which the patient lies while one of 3 different-sized PST devices are moved to the injured/diseased body part. The second mode of administration

(#2,330,690 – An apparatus for the treatment of disorders of issue and /or the joints) is a

portable structure which fits around neck or jaw to administer PST to that area.

There are eight US patents under Markoll, the inventor of PST devices, for use of this technology

on humans. One is the original patent (#5,131,904), to which the subsequent continuation patents refer back. It appears that the same technology is used in all cases. The patents differ in the condition treated, the body part to which treatment is applied, or the apparatus that supports the patient while treatment is administered. As mentioned previously, none of these devices is

identified as having FDA approval.

3.4.3     Definition of technology

The material provided to WCB by the Vancouver PST Center clearly states that PST is distinct

from PEMF, another PEME device:

“PEMF, which works with pulsed electromagnetic fields, utilizes a direct current oriented, constantly repeating signal. This is transmitted at a particular intensity and particular frequency. The pulse is constant for the duration of its application to the joint.

PST should be regarded as a logical extension of PEMF… In contrast to PEMF, PST operates by specific physiological changing rectangular pulses as stimuli, which are transmitted in a programmed alternating fashion that mimics the body’s natural streaming potentials for the duration of the one-hour treatment. The intensity of these rectangular pulses lies predominantly in the range of 0.5 to 1.5 militesla. The frequency ranges from 10 to 20 Hz. Thus, PST works at relatively low biological frequencies as well as in a low energy domain, with regard to field strength.” ¹⁹

Pulsed Signal Therapy in musculoskeletal conditions6 BC Office of Health Technology Assessment

Figure diagrams are included in the Centers material which illustrate the contrasting intensities of field strength and frequency. (Figures 1 & 2)

Figure 1:     Pulsed Electromagnetic Field Devices ¹⁹

Figure 2: Pulsed Signal Therapy with alternating rectangular pulses as physiological stimuli ¹⁹

In consultation with a WCB engineer, it is accepted that PST may indeed differ from PEMF and/or other PEME devices.³ The principal point of difference is that PST may deliver a variable intensity in the pulsed signal, as opposed to the fixed intensity of the PEMF pulsed signal.

While this distinction is noted, the present systematic review does not seek to evaluate whether the various devices have the electromagnetic properties claimed for them. The aim, rather, is to determine the clinical outcome of the devices as identified. In other words, accepting that PST is distinct from PEMF (or all PEME devices), the question is: what is the clinical effectiveness difference as a result of the distinction?

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4           METHODOLOGY

A systematic search and appraisal of the literature was conducted using the following criteria and parameters.

4.1      Criteria for considering studies for review

4.1.1     Participants

Individuals with non-fracture musculoskeletal conditions: ²⁰

• osteoarthritic defects of the shoulder, elbow, hand, thumb, and fingers

• ligament defects, including ‘tennis elbow’ and ‘golfer’s arm’

• shoulder defects such as torn rotator cuff and ‘pitcher’s shoulder’

• carpal-tunnel syndrome and related repetitive-stress injuries

• injured ligaments and calcium deposits

• tendonitis

• osteoarthritic defects of the knee

• anterior cruciate ligament injuries

• knee-strain and knee-cap problems

• meniscus degeneration

• foot and ankle joint problems

• Achilles’ tendon injuries

• splayfoot and heel spurs

• degenerative osteoarthritic defects

• lower-back problems (lumbago)

• slipped-disc, sciatica, muscle spasm

• neck-whiplash syndrome

• bursitis

4.1.2     Intervention

Studies were included if interventions were described as the application of pulsed signal therapy (PST) for the purpose of effecting health benefits. A technology is classified as PST if it is called PST by the authors, or if it is described as having the technological features that are unique to PST, specifically, variable pulse intensity and frequency.

Pulsed Signal Therapy in musculoskeletal conditions8 BC Office of Health Technology Assessment

4.1.3     Outcome measures

Studies were included if they reported any measure of a health outcome pertaining to the clinical effect of pulsed or oscillating magnetic fields, including:

• increased healing

• reduced swelling

• increased mobility, and

• reduced pain.

4.1.4     Types of Studies

All randomized controlled trials involving PST were retrieved. Only trials comparing PST with an alternative PEME device were critically appraised.

4.1.5     Language

English and non-English articles were included.

4.2      Exclusion criteria

Research was excluded that:

• reported physiological or laboratory parameters only;

• pertained to malignant conditions;

• was conducted on animal models or in vitro;

• dealt solely with fracture non-union conditions;

• looked at transcutaneous electrical nerve stimulation (TENS/TNS);

• was conducted on post-surgical patients;

• dealt with epiphyseal disease (eg: Legge-Perthes’ disease);

• did not use PST.

4.4         Search strategies for identification and retrieval of information

An electronic search of the literature was undertaken, aimed at ensuring comprehensive coverage of both traditional and complementary literature.

Several medical bibliographic databases were searched via DIALOG to ensure coverage of tradit-ional and complementary literature: Medline, Embase, Biosis Previews, SciSearch, Mantis, Allied & Alternative Medicine, SPORTdiscus, TGG Health & Wellness, CAB Health, HealthSTAR, Conference Papers Index, and Elsevier Biobase. Databases were searched from 1980 to 2000.

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All terminology was reviewed by Technology Assessment Committee members. Search terms were selected in an effort to reflect the diverse terms and terminology used to refer to pulsed signal therapy. Keywords such as “electromagnetics”, “magnetic”, or “electrical” were combined with “fields”, “therapy”, or “stimulation” and then further combined with “pulse”, “pulsed”, or “pulsing”. These keywords were limited to title or descriptor fields, in order to improve the relevance of the search results. In addition, the phrase “pulsed signal therapy” was searched throughout the body of the record (i.e. title, key words, abstract).

A range of synonyms was selected to cover possible soft tissue disorders. For example, keywords such as “tendin”, “tendon”, “meniscus”, or “ligament”, plus many others were searched in title and descriptor fields. This set was combined with the search results from the set of pulsed signal therapy.

To identify research methodologies used to evaluate the treatment, a range of keywords was searched throughout the body of the record. Keywords included “trial”, “cohort”, “multivariate analysis”, and “expert panel”. These results were then combined with the results from the previous sets.

A search was conducted by authors: DH Trock, C Hershler, R Markoll, S Kornhauser, A Binder, T Zizic, and J Moffett. The results of the author search were not limited by date.

A fugitive literature search was undertaken to identify documents not referenced in technical reports, unpublished material, conference proceedings, theses, as well as government papers and policy documents not controlled by commercial publishers.

Full details of the search strategy and fugitive sources used are given in Appendix C.

Search results were reviewed independently by the authors. Each applied the inclusion and exclusion criteria to the identified literature. Disagreements were resolved by discussion. All articles that appeared to meet the inclusion criteria were requested in full text, and again appraised independently by the authors. The reference lists from the articles retrieved in the search were reviewed to identify further relevant citations. All the articles obtained are listed in the Bibliography.

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4.4      Critical appraisal

All articles which met the inclusion/exclusion criteria were critically analysed by two members of the Technology Assessment Committee, using an Intervention Study Appraisal Form (Appendix D), developed by the BC Office of Health Technology Assessment following

the work of Sackett et al,²¹ and Schechter & LeBlanc.²² Any discrepancy in the findings of reviewers was resolved through discussion.

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5           RESULTS

5.1      Search findings

Thirty-nine references were identified and retrieved. The inclusion/exclusion criteria were applied, and based on the findings, 27 were excluded (Appendix E), and 12 were found to be randomized controlled trials of therapy with a pulsed electromagnetic energy device. Assessment of the descriptions and technical specifications are presented in Appendix F.

Based on our inclusion/exclusion criteria, 11 of the 12 trials were excluded because they were not studies of PST, but of other PEME devices. The 11 excluded trials were:

• four trials evaluating pulsed electromagnetic field (PEMF) therapy (previously distinguished from PST in Section 3.4.3);

• two trials of Diapulse, two of pulsed electromagnetic therapy (PEMT), and one of pulsed short wave (PSW), none of which were called or described as PST, or described as operating “by specific physiological changing rectangular pulses”¹⁹(p 2); and

• two were non-English articles that, when translated, did not describe the variable pulses unique to PST.

There were no trials comparing PST with an alternative PEME device. Only one of the identified trials was an assessment of PST, Menkes et al, described below. This trial was placebo-controlled and not a comparison with any other form of PEME. The 11 trials of

non-PST devices are described in Appendix G.

5.2      Summary of Menkes et al (1998) ²³

This unpublished report is a description of the study conducted in France by Menkes et al ²³  in 1998.

5.2.1     Purpose

This trial assessed the effectiveness and tolerance of pulsed signal therapy (PST) for painful osteoarthritis.

5.2.2     Design

This is a randomized, placebo controlled trial. The study was described as double-blinded, although the authors do not specify how blinding was achieved or who was blinded.

Pulsed Signal Therapy in musculoskeletal conditions12 BC Office of Health Technology Assessment

5.2.3     Population

Forty patients older than age 50 with painful osteoarthritis (according to the criteria of the American College of Rheumatology, for the diagnosis of osteoarthritis of the knee) were randomized into a treatment group (21 patients) and a placebo control group (19 patients). There was no sample size / power calculation given to support this number. Seven control, and eight treatment patients withdrew prior to the 3-month follow-up evaluation.

5.2.4     Treatment

Each patient had 9 one-hour sessions of PST on consecutive days.   No description of the placebo

is given.

5.2.5     Primary outcome measures

The primary outcome was patient assessment of spontaneous pain at rest and in motion using a visual analogue scale (VAS), with 0 being no pain and 100 being the highest level of pain.

5.2.6     Secondary outcome measures

• Patient assessment of spontaneous pain at rest and in motion using a verbal scale;

• assessment of pain or discomfort in everyday life (24-point algofunctional Lequesne index); and

• quality of life (SF-36).

5.2.7     Analytical method

Placebo and treatment groups were compared at each follow-up point, and analysis of variance by rank was performed to account for the effect of time. No analysis of the change from baseline within each group was conducted.

For the primary outcome variable, each analysis was performed in two ways: 1) comparing the values recorded at each patient evaluation (values recorded); and 2) recording the last values carried forward to subsequent measurement times on those who withdrew early (end-point).

5.2.8     Results

No significant differences in clinical characteristics were found at baseline. The high rate of withdrawal (37.5%), however limits the validity of the results.

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The authors reported a small difference between the active treatment group and the placebo group in the primary outcome variables at two of the three assessment points. They found a significant difference in the mean VAS measurement of pain in motion at day 9 (41.8±23.6 vs. 59.5±24.2; p=0.02), and month 3 (32.3± 23.8 vs. 59.9± 34.0; p=0.03), in the recorded value analysis. Similar results were found in the end-point analysis. There were no significant differences found in any of the analyses of pain at rest.

Secondary outcome measures were compared between the two groups for each outcome at baseline, day 9, month 1, and month 3. In all, at least 76 tests of significance were conducted. Of these, 15 showed a statistically significant difference (p < 0.05) between the treatment and placebo groups; there was no adjustment made for the number of comparisons done. Because of the small sample size (n=40), this study is unable to identify any small differences that may exist between the placebo and treatment groups.

The findings for the secondary outcome measures support the primary outcome findings with virtually no difference between the two groups. These outcomes are summarised in Table 1.

The Technology Assessment Committee reviewers agree with the study authors that no valid conclusions can be drawn from this trial. Larger, longer, and better-conducted RCTs are needed to establish effectiveness versus placebo.

Table 1:   Summary of secondary outcomes – Menkes et al (1998) ²³

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6       DISCUSSION

PST is one of a number of different pulsed electromagnetic energy (PEME) devices. Assessment of the technical specifications of PST shows that, as compared with other PEME devices, there are differences in specific parameters. PST has a different combination of pulse duration, frequency, and magnetic-field strength, compared to any other PEME device studied. The random nature of the pulses and pauses in PST is also said to be unique. It is not known, however, whether these differences produce different clinical effects. The PST Centers make claims about differences in clinical outcomes of PST as against other PEME devices, and the cost of the services they provide is based on this assumption of difference.

Particular confusion exists regarding the distinction between PST and PEMF. Studies of PEMF are often cited by PST Centers’ literature and publications in support of PST.

The Research Overview section of the Pulsed Signal Therapy Centers’ website states that “Researchers at Yale University School of Medicine began clinical trials on a Pulsed Signal Therapy device in 1990 to see how well this technology would work on humans.” ²⁴ Although not cited by name, these are evidently the studies by Trock et al.^2,10

Hershler et al,⁶ in their report of a case series of patients using PST at the Vancouver PST Center, also cite Trock et al’s studies in support of efficacy claims. They state “Randomized, placebo controlled, double blind studies showed that between 70 and 80% of osteoarthritis patients who received PST experienced a significant reduction in chronic pain”.⁶ (p168)

The Trock et al ² study is an investigation of PEMF, and therefore was excluded from critical appraisal in this report. It is, however, discussed at this point, since the study may contribute to the evidence of effectiveness of the class of PEME devices that include PEMF and PST.

Trock et al ² conducted a double-blind, randomized, placebo controlled trial of PEMF on 167 patients with osteoarthritis of either the knee or cervical spine. The outcome of interest was reduction of pain (evaluated with a VAS and physician assessment), and improvement in activities of daily living (evaluated with a patient questionnaire). At the end of treatment, the mean level of improvement from baseline was always higher for the treated patients than the placebo group.

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The difference was statistically significant, favouring PEMF for pain (27.21 vs. 14.03; p=0.005), and pain on passive motion (0.70 vs. 0.41; p=0.045), but not ADL difficulty and joint tenderness. One month following treatment, statistically significant differences favouring PEMF were found in pain (24.77 vs. 11.86; p=0.018), pain on passive motion (0.78 vs. 0.16; p<0.001), and joint tenderness (0.73 vs. 0.21; p=0.001). In all, there were 110 tests of significance favouring PEMF reported, of which 25 were significant (p < 0.001).

Many participants in Trock et al received co-interventions at the time of the trial, including pain medications and physiotherapy, which were not controlled for in the study analysis. Furthermore, while the physician assessing the patient was blinded to the random assignment of each patient, the therapy technician was not. It is not known how well the patients were blinded.

The efficacy references made by PST Centers imply that PST and PEMF are the same, and yet distinct. The PST Centers claim that the effectiveness evidence for PEMF supports PST, which may be the case. The claim that PST is distinct and preferable to PEMF and the class of PEME devices is unfounded, however.

Electromagnetic devices are numerous, their similarities and differences confusing, and research papers investigating potential clinical benefits are substantial in volume. This evidence is difficult to organize, in large part because electromagnetic devices are almost always only one component of a complex therapeutic program. It should also be noted that

the inclusive payment practice already mentioned makes utilization analysis from WCB administrative claims data virtually impossible.

PST is patented and has been approved for marketing in Canada, but the technology has not received regulatory approval from the Food and Drug Administration (FDA) in the United States. The FDA, unlike its Canadian counterpart, evaluates effectiveness evidence. The patents and licences of PST were investigated to see if they would clarify the contradiction discussed above. Other than delineating the technical distinction (outlined in 3.4.3 above), no other assertion of difference was found to describe how PST might confer a distinct therapeutic advantage.

Pulsed Signal Therapy in musculoskeletal conditions16 BC Office of Health Technology Assessment

7       CONCLUSIONS

There is no trial demonstrating that PST provides a significant effectiveness and safety therapeutic advantage over other musculoskeletal injury treatment devices that use magnetic pulses to induce electrical current, in injured tissue. There is also little evidence that PST provides a significant effectiveness and safety therapeutic advantage over placebo.

There are no published, controlled trials comparing PST with generic PEME therapies. Only one small (n=40), short (3 months), unpublished randomized controlled trial of PST could be located (Menkes et al ²³), which studied its use in osteoarthritis of the knee. This study provides no valid evidence that PST is more effective than placebo at treating the symptoms of osteoarthritis.

There are no published controlled, clinical trials showing that PST provides a clinical advantage versus placebo or other PEME devices.

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APPENDICES

APPENDIX A:   Prioritizing criteria applied to Pulsed Signal Therapy

APPENDIX B:   Patents

Canadian Patents *

1.    #2,082,170 – Magnetic field therapy and apparatus (July 1996).

“Process involves treating organs by applying a magnetic field by way of an annular coil surrounding the organ, the coil being energized by a pure DC voltage having a rectangular wave form pulsing at the rate of 1-30 CPS. The invention also includes an apparatus comprising a body support encompassed by an annular coil energized as above. The coil is mounted on a carriage running on tracks adjacent the body support.”

1. 2.      #2,330,690 – An apparatus for the treatment of disorders of issue and /or the joints (November 1999).

“An apparatus for the treatment of disorders of tissue and/or the joints in the area of the jaw or neck of the patient, particularly for the treatment of periodontosis, is depicted, wherein the

apparatus comprises a housing that surrounds at least the area of the jaw or neck to be treated A number of coils is also provided for generating at least one electromagnetic field which can be applied to the area to be treated. The coils are arranged in the interior of the housing.”

U.S. Patents ^†

1. 3.      #5,131,904 – Treatment of arthritis with magnetic field therapy and apparatus therefore (July 1992).

The abstract given in this patent description is the same as that given for Canadian patent # 2,082,170 (1. above), and US patent #5,842,966 (6. below). The major difference appears to be that this patent was issued to the inventor, independent of the company, Bio-magnetic Therapy Systems, Inc. and although this patent describes the table that is used to administer the therapy, it is not mentioned in the list of claims. A copy of the Certificate for United States Patent for this patent was given to WCB by the Vancouver PST Center.

1. 4.      #5,387,176 – Treatment of acute diseases as caused by the sports-type injuries of the musculoskeletal system (excluding fractures) with magnetic field therapy (February 1995).

“Process involves treating acute diseases of a body organ of the musculoskeletal system by applying a magnetic field by means of an annular coil surrounding the diseased organ, the coil being energized by a pure DC voltage having a rectangular wave form pulsing at the rate of 1-30 CPS.”

*      Information of patents issued in Canada can be found at The Canadian Intellectual Property Office: http://strategis.ic.gc.ca/sc_mrksv/cipo/welcome/welcom-e.html

†     Information of patents issued in the United States can be found at the United States Patent and Trademark Office: http://www.uspto.gov/patft/index.html

1. 5.      #5,453,073 – Apparatus for treatment of diseased body organs with magnetic field therapy (September 1995).

The abstract for this patent is the same as for Canadian patent #2,082,170 (1. above).

1. 6.      #5,665, 049 – Treatment of acute diseases as caused by the sports-type injuries of the musculoskeletal system (excluding fractures) with magnetic field therapy (September 1997).

Same as US patent #5,387,176 with the addition of a claim stating that “the diseased body organ is disposed eccentric of the axis of the coil.”

1. 7.      #5,669,868 – Treatment of wrinkled discolored or aging skin with magnetic field therapy (September 1997).

“Process involves treating skin by subjecting it to magnetic therapy by an annular coil energized by pulsed DC voltage having rectangular wave from pulsing at the rate of 1-30 CPS, the coil producing a field of under 20 gauss.”

1. 8.      #5,842,966 – Treatment of arthritis with magnetic field therapy (December 1998).

This is the same device as described for the Canadian patent #2,082,170 and US patent #5,131,904 (1. & 3. above).

1. 9.      #D407,819 – Treatment bed (April 1999).

This “Design Patent” describes a treatment bed similar to the one in other patents.

1. 10.  #6,048,302 – Apparatus for the treatment of disorders of tissue and/or the joints (April 2000)

This is the same device as described for the Canadian patent #2,330,690 (2. above).

APPENDIX C:   Search strategy

1. I.   TRADITIONAL SEARCH

1. DIALOG databases searched

APPENDIX D:    BCOHTA intervention study appraisal form

BC OFFICE OF HEALTH TECHNOLOGY ASSESSMENT

Centre for Health Services and Policy Research

University of British Columbia

(Appendix D – continued)

2.

APPENDIX E:   Excluded articles

* Full citations are given in the Bibliography.

APPENDIX F:   Technical specifications of devices in RCTs

APPENDIX G:   Randomized controlled trials of non-PST PEME devices

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BACKGROUND: Specific pulsed electromagnetic fields (PEMFs) have been shown to induce analgesia (antinociception) in snails, rodents and healthy human volunteers.

OBJECTIVE: The effect of specific PEMF exposure on pain and anxiety ratings was investigated in two patient populations.

DESIGN: A double-blind, randomized, placebo-controlled parallel design was used.

METHOD: The present study investigated the effects of an acute 30 min magnetic field exposure (less than or equal to 400 µT_pk; less than 3 kHz) on pain (McGill Pain Questionnaire [MPQ], visual ana-logue scale [VAS]) and anxiety (VAS) ratings in female rheumatoid arthritis (RA) (n=13; mean age 52 years) and fibromyalgia (FM) patients (n=18; mean age 51 years) who received either the PEMF or sham exposure treatment.

RESULTS: A repeated measures analysis revealed a significant pre-post-testing by condition interaction for the MPQ Pain Rating Index total for the RA patients, F(1,11)=5.09, P<0.05, estimate of effect size = 0.32, power = 0.54. A significant pre-post-effect for the same variable was present for the FM patients, F(1,15)=16.2, P<0.01, estimate of effect size = 0.52, power =0.96. Similar findings were found for MPQ subcomponents and the VAS (pain). There was no significant reduction in VAS anxiety ratings pre- to post-exposure for either the RA or FM patients.

CONCLUSION: These findings provide some initial support for the use of PEMF exposure in reducing pain in chronic pain populations and warrants continued investigation into the use of PEMF exposure for short-term pain relief.

Key Words: Analgesia; Fibromyalgia; Pain therapy; Pulsed electromagnetic fields; Rheumatoid arthritis

CONTEXTE : Certains champs électromagnétiques pulsés (CEP) pro-duisent un effet analgésique (antinociceptif) chez les escargots, les rongeurs et les sujets volontaires humains.

¹Lawson Health Research Institute, St Joseph’s Health Care; ²Department of Medical Biophysics; ³Department of Medicine, Division of Rheumatology; ⁴Department of Psychology, The University of Western Ontario, London, Ontario

Correspondence and reprints: Dr Alex W Thomas, St Joseph’s Health Care, 268 Grosvenor Street, London, Ontario N6A 4V2. Telephone 519-646-6000 ext 64191, fax 519-646-6399, e-mail athomas@lawsonimaging.ca

patients with rheumatoid arthritis (RA) and fibromyalgia (FM) (13). The recent report (14) that a similar PEMF can reduce depression in patients with bipolar depression suggests that a PEMF can also influence affective state.

Taken  together,  these  findings  suggest  that  such  weak PEMFs may alter pain perception in patients with chronic pain. We report here the effects of a 30 min exposure to a PEMF on pain levels in FM and RA patients using a double-blind, randomized, placebo-controlled parallel design.

PATIENTS AND METHODS

Participants 

This study was approved by the Research Ethics Board for the Review of Health Sciences Research Involving Human Subjects at the University of Western Ontario, London, Ontario.

Thirteen female RA patients in study 1 (mean age 52.23 years, range 29 to 79 years) and 18 female FM patients in study 2 (mean age 51.28 years, range 35 to 67 years) were recruited from day treatment programs at St Joseph’s Health Care (London, Ontario). Participation in the program required a physician referral following a positive diagnosis for RA or FM by a rheuma-tologist (15,16). There were standardized criteria for chronic pain patients to be included in the program, which included pain history, diagnostic criteria and chronic pain level. The authors did not have access to the patients’ medical history, the population was not preselected in any way and selection bias was not applied.

It was thought that this enrollment method provided the most robust and critical method for testing the treatment. Patients were narcotic free during the present study and were screened for depres-sive symptoms (concomitant depression was an exclusion criterion for the program). Subjects were numerically and randomly assigned on a computer-generated list and all blinding (data, equipment and exposure condition) was maintained by staff outside of the study.

Of  the  RA  patients,  seven  were  randomly  assigned  to  the PEMF group (mean age 54 years, SD=15.87) and six were randomly assigned to the sham exposure group (mean age 50.71 years, SD=12.0). No patients withdrew from the study before completion of the study requirements. Nine of the FM patients were randomly assigned to each of the PEMF (mean age 51.5 years, SD=9.07) and sham (mean age 51 years, SD=9.90) exposure groups. One FM patient withdrew (sham group) before the exposure period due to feelings of anxiety unrelated to the research conditions.

Materials

All subjects were seated in a comfortable chair in a quiet room.

A headset fitted with coils beneath the plastic ear coverings and connected by a wire to the portable PEMF generating unit was placed with the earpieces covering the patient’s temples. The head-set covered the area that extended from above the temple to just above and behind the ear, on both sides of the head. Consequently, the treatment area was the area of the central nervous system that went from immediately above the temple to just above and behind the ear, extending from the outer periphery of the cingulate cortex to the brain midline. The PEMF unit was designed to have two pulse sequence patterns: one pattern was set to deliver a zero-amplitude magnetic field (MF) exposure (sham), while the other pattern pro-duced a PEMF of a maximum of 200 µT (2 Gauss) to the deep brain and a maximum of 400 µT (4 Gauss) at the headset. The frequency content of the MF as determined by Fourier analysis was less than 1 kHz. The pulse design used in the current study is described in the

United States patent #6,234,953 (8).

The MF was not physically detectable by either the experimenter or the participant. No sound or vibration was emitted and there were no visual indicators on the unit other than a blinded ‘a’ or ‘b’ switch setting for conditions. The experimenter was provided with a randomized and blinded schedule of the ‘a’ or ‘b’ switch settings before each run of sessions for a day.

The McGill Pain Questionnaire (MPQ) (17) was used to assess subjective measures of clinical pain both before and after the delivery of the PEMF or sham exposure. This questionnaire consisted of four major classes of word descriptors: sensory, affective, evaluative and miscellaneous. Patients were asked to select the most fitting word in each of the 20 categories that pertained to their current pain level. A category was omitted if none of the words were relevant to the patient’s pain. Words within each category were ranked in order of appearance; a sum of the selected words according to their ranking provided the clinician with a Pain Rating Index (PRI). In addition to the PRI, an overall Present Pain Intensity (PPI) measure was provided on the questionnaire. This question asked patients to indicate their level of current pain intensity on a six-point Likert scale, ranging from no pain (0) to excruciating pain (5). The MPQ has been successfully tested for reliability and validity (17).

Visual analogue scales (VAS) (18) were used to assess levels of pain and anxiety, both before (pre) and after (post) MF or sham exposure. The pain scales ranged from no pain to worst possible pain.

The anxiety scale ranged from no anxiety to worst possible anxiety.

The Beck Depression Inventory-II (BDI-II; The Psychological Corporation, USA), the most widely used instrument for detecting depression, is consistent with diagnostic criteria listed in the Diagnostic and Statistical Manual of Mental Health Disorders-IV (19).

This questionnaire was quick and easy to complete; it contained four to six sentences from which individuals were expected to select the one that best described their experiences over the pre-vious two weeks. The BDI-II has been shown to provide reliable, internally consistent and valid scores in medical settings (20).

This questionnaire was administered at the beginning of the study to verify the patients’ depression level.

Procedure

Patients were randomly assigned to either the sham (no PEMF exposure) or the PEMF exposure conditions. The purpose of the study was explained and informed consent was obtained from the patients before the beginning of the experiment.

Once seated comfortably in the chair, patients completed the MPQ, the VAS for both pain and anxiety and the BDI-II. Patients were also asked to report their handedness and when their last menstrual cycle ended. The headset was then secured on the patients’ temples. After 15 min of recording physiological data (heart rate and respiration), the PEMF device was set to deliver the random but blind condition. Following 30 min of PEMF or sham exposure, an additional 10 min of rest (with no exposure) was recorded after which the MPQ and the pain and anxiety VAS scales were completed a second time. Patients were left alone in the experiment room but were provided with a paging device to have access to the experimenter at any time. The specific settings for the sham and PEMF exposure were kept blind to both the patient and the experimenter, and the code was broken following all data collection. Participants were queried as to which condition they thought they had received and asked if they had anything else such as adverse events to report. Analysis indicated that the participants guessed their condition at a random rate (their guess was not significantly correlated to the actual condition).

PEMF exposure and pain

TABLE 1

Summary of pain and anxiety ratings, pre- and post-magnetic field or sham exposure conditions for rheumatoid arthritis patients

RESULTS

Study 1: RA patients

Demographic information: There was no significant difference in age between patients randomly assigned to the two groups, t(11)=–0.43, P>0.1.

Pain ratings: A significant interaction was found between the pre-post pain rating and type of exposure, ie, the effect of pre-test versus post-test condition on pain ratings differed across the exposure conditions, with a large reduction of pain noted in the PEMF-exposed group and a lesser reduction in the sham exposed group. Table 1 displays the specific numbers and sig-nificance values for the overall and subcomponent parts (including the PPI) of the MPQ. Specifically, a repeated measures ANOVA revealed the significant pre-post × condition interaction for the MPQ PRI (Total), F(1,11)=5.09, P<0.05, partial eta²=0.32, power = 0.54. This was confirmed by t test due to the disparity in pre-exposure pain levels between the two groups (pre-score minus post-score tested between the sham and MF conditions [t=2.26, P<0.05]). There was also a significant main effect of pre-post testing, F(1,11)=37.51, P<0.01, partial eta²=0.77, power = 1.0.

Similar findings were found for the miscellaneous subscale of the MPQ. Results from the sensory, affective and evaluative sub-scales, as well as the PPI of the MPQ, revealed significant main effects of pre-post testing; however, prepost testing × condition interactions were nonsignificant.

VAS – Pain: The only significant change using the VAS pain rating was found within the PEMF group: these patients had reduced pain ratings after the PEMF exposure. Conversely, PEMF versus sham exposure on the VAS pain rating did not differ between the pre-test and post-test times, and the effect of test time on its own did not lead to any changes in pain rating (Table 1).

Specifically, patients randomly assigned to the PEMF groups had significantly reduced pain ratings following their exposure period, F(1,6)=7.84, P<0.05, partial eta²=0.57, power = 0.65; patients in the sham exposure group did not report sig-nificantly reduced VAS pain ratings, F(1,5)=0.05, P>0.10, par-tial eta²=0.01, power = 0.05. The pre-post-testing × condition (PEMF versus sham exposure) interaction for VAS pain ratings was nonsignificant, F(1,11)=3.95, P>0.10, partial eta²=0.26, power = 0.44. The main effect of pre-post-testing was also non-significant, F(1,11)=3.95, P>0.10, partial eta²=0.26, power = 0.44.

VAS – Anxiety: Table 1 displays the mean anxiety ratings reported by RA patients randomly assigned to the PEMF and sham exposure groups both pre- and post-exposure. Analysis of these results revealed a nonsignificant reduction in anxiety ratings, F(1,11)=1.64, P>0.10, partial eta²=0.13, power = 0.22. Furthermore, there was no significant condition by pre-post testing interaction for anxiety ratings, F(1,11)=1.45, P>0.10, partial eta²=0.12, power = 0.20.

Study 2: FM patients

Demographic information: There was no significant difference in age between patients randomly assigned to the two groups, t(15)=0.11, P>0.10.

Pain ratings: Using the MPQ, the only decreases in pain ratings were made by the subjects that were assigned to the PEMF group. Repeated measures ANOVA revealed a signifi-cant overall pre-post-effect for the MPQ PRI (Total), F(1,15)=16.16, P<0.01, partial eta²=0.52, power = 0.96. The PEMF group, F(1,8)=17.60, P<0.01, partial eta²=0.69, power = 0.96, but not the sham group, F(1,7)=3.98, P=0.09, partial eta²=0.36, power = 0.41 showed a significant decrease in the overall pain rating following the exposure period. There was no significant interaction between pre-post-testing and condi-tion (sham versus PEMF exposure) on this pain rating meas-ure, F(1,15)=0.32, P=0.58, partial eta²=0.02, power = 0.08.

TABLE 2

Summary of pain and anxiety ratings, pre- and post-magnetic field or sham exposure conditions for fibromyalgia patients

The miscellaneous subscale of the questionnaire did not yield the same results; there was no significant effect of pre-post-testing across groups (F[1,15]=2.19, P=0.16, partial eta²=0.13, power = 0.28), of pre-post-testing for the PEMF (F[1,8]=3.33, P=0.11, partial eta²=0.29, power = 0.36) or sham groups (F[1,7]=0.18, P=0.68, partial eta²=0.03, power = 0.07), or of pre-post-testing by condition interaction (F[1,15]=0.64, P=0.44, partial eta²=0.04, power = 0.12). In contrast, there was a significant pre-post effect across groups (F[1,28]= 35.05, P=0.001, partial eta²=0.56, power = 1.00) for the PPI scores. These scores were signifi-cantly decreased pre- to post-exposure for both the PEMF-exposed group of patients (F[1,9]=18.00, P=0.003, partial eta²=0.69, power = 0.96) and the sham-exposed patients (F[1,7]=24.65, P=0.002, partial eta²=0.78, power = 0.99).

VAS – Pain: Using the pain ratings from the VAS, a signifi-cant decrease in pain ratings was found after both sham and PEMF exposure (Table 2). A significant pre-post exposure effect was noted for VAS pain ratings, F(1,13)=23.70, P<0.001, partial eta²=0.65, power = 1.00, with decreased pain scores present following the exposure period. Patients randomly assigned to both the PEMF and sham groups had significantly reduced pain ratings following their exposure period, F(1,7)=26.85, P<0.01, partial eta²=0.79, power = 0.99 and F(1,6)=6.39, P<0.05, partial eta²=0.52, power = 0.56 for the PEMF and sham groups, respectively. No pre-post-testing by condition interaction existed.

VAS – Anxiety: Table 2 displays the average anxiety ratings reported by patients randomly assigned to the PEMF and sham exposure groups both pre- and post-exposure. Analysis of these results revealed a significant overall reduction in anxiety ratings across the entire patient pool, F(1,13)=5.21, P<0.05, partial eta²=0.29, power = 0.56; however, anxiety ratings did not significantly change across pre-post-testing for patients when analyzed separately by group, F(1,7)=2.83, P=0.14, partial eta²=0.29, power = 0.31 and F(1,6)=2.59, P=0.16, partial eta²=0.30, power = 0.27 for the PEMF and sham groups, respectively. Furthermore, there was no significant condition by pre-post-testing interaction for anxiety ratings, F(1,13)=0.50, P=0.49, partial eta²=0.04, power = 0.10.

DISCUSSION

The results indicate that exposure to a specific low-frequency PEMF appears to have some beneficial analgesic properties, particularly in patients with RA. The results for the FM patient sample were mixed.

Pain ratings (MPQ and VAS)

Both the RA and FM patients randomly assigned to the sham and PEMF exposure groups reported decreased pain ratings fol-lowing the 30 min trial period. Specifically, the RA patients exposed to the PEMF experienced a larger reduction in pain ratings than patients in the sham exposure group according to the pain rating on the MPQ (total) and VAS. For the FM patients, those in the PEMF group also had post-exposure pain ratings on the MPQ (total) that were more reduced by the exposure period (a priori hypothesis) compared with the control subjects; however, on the VAS, the FM patients who received both the PEMF and sham exposure showed a decrease in pain, with a greater decrease in the PEMF-exposed group. For RA patients, these findings were supported by the presence of a significant condition by time of testing interaction. Patients randomly assigned to the PEMF group had a significantly greater reduction in MPQ PRI scores than those in the sham exposure group.

All patients in the present study reported decreased pain ratings across time, an occurrence that can be attributed to the placebo effect. As defined by Kleinman et al (21), the placebo effect is the observation of a psychological or phys-iological change associated with inert treatments, sham pro-cedures or therapeutic encounters. In the present study, patients were exposed to a therapeutic encounter: adminis-tration of either PEMF or sham exposure. For some of these patients, no treatment modality administered before partic-ipation in the current study, either pharmacological or non-pharmacological, was providing pain relief. The presence of a potentially effective and beneficial therapeutic treatment was likely encouraging to these patients; the potential ben-efit may have driven these patients to voluntarily partici-pate in the study and expect a benefit.

The partial eta² values obtained for patients in the two expo-sure groups (PEMF and sham) are consistent with the view that PEMF exposure confers a benefit greater than that obtained by expectancy or the placebo effect. For RA patients, the average partial eta² value obtained for the pain ratings was 0.87 for patients in the PEMF group and 0.56 for the sham-exposed patients. Values for the FM patients were 0.69 and 0.36 for the PEMF and sham exposure groups, respectively.

Aside from the placebo effect, decreases in pain ratings for patients randomly assigned to the sham group can be attributed to relaxation. Staud et al (22) have reported that patients with FM report improvements in chronic pain following periods of rest. In the present study, the 55 min experimental period in which patients were seated in a comfortable chair could be considered a setting of relaxation; this time period of relaxation may have been the catalyst for reduced pain ratings post-exposure. Alternatively, activities in which the patients partook before enrollment and/or participation in the present study (eg, exercise training, household work), which were not con-trolled by the study administrators, may have exacerbated the patients’ pain symptoms (22), resulting in elevated pre-exposure pain ratings for patients in both the PEMF and sham exposure groups. Even if relaxation or prior activity participation were the cause of altered pain ratings, patients in the PEMF group benefited from significantly reduced pain ratings on a number of the tested scales (eg, PRI) post-exposure while patients in the sham exposure group did not.

Pain ratings assessed via the PPI and the VAS provided mixed results for both patient populations. Patients in the PEMF group for both patient populations reported significantly reduced VAS scores; however, of the sham-exposed patients, only the patients in the FM sample reported significantly reduced scores. For the PPI, significantly reduced scores were reported for RA patients in the sham exposure group and FM patients in the PEMF and sham exposure groups. PPI scores were not significantly reduced for RA patients in the PEMF group. One possible explanation for these results is that both the VAS and PPI refer to the intensity of the experienced pain in contrast to the quality of pain that is meas-ured through the PRI. By memory alone, patients can improve their pain rating on the PPI.