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| A Survey of to Determine the Effectiveness of Magnopulse LegCare Magnetic Leg Wraps on Swollen and Painful Legs. |
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Dr Nyjon.K.Eccles BSc MBBS PhD MRCP
& Derek R. Price
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Contents
Abstract
A survey was conducted of 202 randomly selected users of Magnopulse LegCare static magnet leg wraps. The majority of the patients, 67%, using the LegCare used it for knee pain. Average duration of pain was 87.2 months with a range 1 to 600 months. Forty-five percent of respondents had associated leg swelling.
The key findings were as follows:
Ninety six percent of respondents said there was a reduction in leg pain after wearing the device. There was an average of 73% reduction in leg pain after wearing the LegCare. This reduction in pain was highly statistically significant (p<0.0001).
Eighty five percent of those who responded had a reduction in pain of at least 50%. Furthermore, 31% had no pain at all after wearing the device and 49% had a reduction in pain of 70% or more. The majority, 75%, had a noticeable reduction in pain within 14 days of wearing the LegCare. More than half (54%) of LegCare users required no further treatment for their leg pain.
Of those who had swelling, 72 of the original 202, 73% reported a reduction in leg swelling after wearing the LegCare. The average reduction in leg swelling after wearing the LegCare was 71%. This reduction in leg swelling was highly statistically significant (p < 0.0001).
Sixty five percent reported an improvement in quality of life after wearing LegCare of which 10% were much better. No doubt this was due to relief of pain and swelling.
No respondent reported any worsening of health from wearing the device.
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Introduction
It has been known for some time that the behaviour of certain types of biological materials are influenced by magnetic fields (Reno & Nutini, 1963). Subtle magnetic fields can produce a physiological effect. For example, pico-tesla range electromagnetic fields have been shown to have significant effects on nerve regeneration (Turing, 1952).
Electrical activity exists in the body at all times e.g. the beating heart. The heart is the biggest electromagnetic field generator in the body (Eyster et al, 1933). Mechanical loading of bones generates electrical currents. The discovery of magnetic material (deposits of magnetite) in the human brain may suggest that we are physiologically designed to respond to magnetic fields ( Kirschvink et al, 1992).
The public acceptance of magnet therapy (and alternative/complementary therapy in general) far outweighs its acceptance by the medical community. We live in an era where evidence-based medicine is vogue. By this we mean evidence of effectiveness or benefit over and above “the placebo”. As with all treatments it is important to know that they are efficacious but also that they are safe. The Japanese have used magnets for years to treat chronic fatigue syndrome and have suggested that an increase in environmental electromagnetic pollution and/or progressive inability to be energized by the earth’s magnetic field (Rosch, 1998) is important in its aetiology. The Yellow Emperor’s Canon of Internal Medicine, some 4,000 years ago also talks about stones and heat and magnets working over acupuncture meridians. In the last 2 decades the Japanese have been using magnets to relieve pain.
There is little doubt that oscillating electromagnetic fields can relieve pain and inflammation but static magnets are motionless magnetic fields until recently there have been very few studies of the efficacy of static magnetic fields in pain.
There are many anecdotal reports of effective pain relief from static magnets from users including athletes (White,1998) and physicians (Weintraub,2000) and unpublished reports of increased healing and reduced pain by physicians (Barnothy,1964; Henren,1997; Ruibal,1997). In 1938, Dr Hanson reported pain relief on himself after application of a static magnet. Estimate worldwide profits from sales of static magnets exceed $5 billion annually. A quest for analgesia would appear to be a major part of these sales and it is hard to believe that devices that were ineffective could sustain this level of turnover. After 2,000 years of deliberation, the jury is still out. A bone growth stimulator, which works by electromagnetism, has an 80% success rate in promoting the union of non-healing fractures and has FDA approval (Bassett et al,1982). A similar device has also been approved for aiding female incontinence (Galloway et al,2000). Armed with this information one would have expected a huge interest in the potential further applications of electromagnetic fields to promote healing in other clinical situations but this field does not appear to occupy a significant proportion of Medical Research. Most early research on magnets took place in Europe but the research in North America is now expanding.
A recent unpublished Systematic review of randomised controlled trials of static magnets for pain relief (Eccles, 2002) showed that overall 9 of the 12 studies reported a significant analgesic effect due to static magnets. Of the 10 better quality studies, 7 were positive and 3 were negative. In 2 of the negative studies there are major concerns over adequacy of magnet power for the type of pain (300 gauss for chronic back pain, Collacott et al, 2000), a query raised by the authors themselves, and of duration of exposure (5 minutes in Harper & Wright, 1977). The latter authors also failed to state the power of the magnet used in their study. Excluding a further 2 studies on grounds of inadequate magnet exposure then 7 out of 8 of the better quality studies demonstrated a positive effect of static magnets in achieving analgesia across a broad range of different types of pain (neuropathic, inflammatory, musculoskeletal, fibromyalgic, rheumatic and post-surgical).
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Objectives
The purpose of this survey was to assess the extent of the effectiveness of LegCare, a static magnet product that is commercially available for the treatment of leg pain. There has been an accumulating wealth of anecdotal evidence of its effectiveness to promote resolution of leg pain. The design of the survey and independent analysis of the data was commissioned by the company Magnopulse, the manufacturers of the product. The survey is also an antecedent to a double blind placebo-controlled trial to investigate the effectiveness UlcerCare, a sister product, in promoting leg ulcer healing and relief of leg pain.
If proven to be as effective as the anecdotal evidence suggests there is an enormous potential saving to the NHS of a simple and yet effective adjunct treatment such as this to existing pain treatments, particularly in the elderly population who not only have a higher incidence of pain due to a higher prevalence of degenerative disease but also who are more susceptible to untoward side effects form pain-relieving medications.
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Location of Pain
Percentage of patients who responded to the question 75%
The majority of the patients, 67%, using the LegCare used it for knee pain.
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Was there a reduction in leg pain?
Percentage response to question 65%
When asked the question “Was there a reduction in leg pain after wearing the device?” 96% responded in the affirmative.
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Pain Reduction
There was an average of 73% reduction in leg pain after wearing the LegCare. This reduction in pain was highly statistically significant (p<0.0001). There was no sex difference in pain reduction (p= 0.679)
Percentage response to the question 64%.
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Level of Pain Reduction
The levels of pain on the above graph refer to the level of pain on a scale of 1-10 after wearing the device. Hence level 0 means no pain. 85% of those who responded had a reduction in pain of at least 50%. 31% had no pain at all after wearing the device. 49% had a reduction in pain of 70% or more.
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Average reduction of leg swelling
Percentage of those with leg swelling that responded to the question 81%
The average reduction in leg swelling after wearing the LegCare was 71%. This reduction in leg swelling was highly statistically significant (p < 0.0001). There was no sex difference in the degree of reduction of leg swelling that was achieved by the device (p = 0.349).
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Summary and Conclusions
Of the 202 patients surveyed there were equal numbers of men and women. Unfortunately, the person conducting the telephone enquiry did not record the ages of the respondents.
The majority of the patients, 67%, using the LegCare used it for knee pain. Average duration of pain was 87.2 months with a range 1 to 600 months. Forty-five percent of respondents had associated leg swelling.
Ninety five percent of patients questioned wore the device for more than 6 hours a day with 29% wearing the device at night only. Ninety six percent of respondents said there was a reduction in leg pain after wearing the device. There was an average of 73% reduction in leg pain after wearing the LegCare. This reduction in pain was highly statistically significant (p<0.0001). There was no sex difference in pain reduction (p= 0.679).
Eighty five percent of those who responded had a reduction in pain of at least 50%. Furthermore, 31% had no pain at all after wearing the device and 49% had a reduction in pain of 70% or more.
The majority, 75%, had a noticeable reduction in pain within 14 days of wearing the LegCare. More than half (54%) of LegCare users required no further treatment for their leg pain. There was a small reduction in intake of painkillers after use of the LegCare but this was not in fact statistically significant (p=0.291). Given the significant reduction of pain reported after wearing the LegCare it is almost certain that the poor response to the question (only 23% of respondents) has undermined the significance of this result.
Of those who had swelling, 72 of the original 202, 73% reported a reduction in leg swelling after wearing the LegCare. The average reduction in leg swelling after wearing the LegCare was 71%. This reduction in leg swelling was highly statistically significant (p < 0.0001). There was no sex difference in the degree of reduction of leg swelling that was achieved by the device (p = 0.349).
Fifteen percent reported an improvement in health but the majority (85%) said their health was the same. Perhaps equally important was that no respondent reported any worsening of health from wearing the device.
Sixty five percent reported an improvement in quality of life after wearing LegCare of which 10% were much better. No doubt this was due to relief of pain and swelling.
A recent systematic review has reported a significant trend towards static magnets being effective analgesics (Eccles, 2002). Overall 9 of the 12 studies reported a significant analgesic effect due to static magnets. Of the 10 better quality studies with 3 points (Table 2 & 3) or more on the quality assessment, 7 were positive and 3 were negative. Seven out of 8 of the better quality studies demonstrated a positive effect of static magnets in achieving analgesia across a broad range of different types of pain (neuropathic, inflammatory, musculoskeletal, fibromyalgic, rheumatic and post-surgical). It is uncertain whether this effect is mediated by a change in circulation and/or an effect on ionic exchange and pain signalling. Generally however, these results together with the evidence cited above clearly point towards static magnets having a significant interaction with human physiology.
Moreover, a recent double blind placebo-controlled trial of LadyCare, another Magnopulse product demonstrated a statistically significant reduction (p< 0.05) in dysmenorrhoea in women who had regular period pain when the device was worn 1-2 days prior to the onset of menses (Eccles, 2002). Seventy percent of the subjects in the LadyCare group had at least a 50% reduction in pain, 47% of whom had a > 75% reduction in pain.
These results are also consistent with the reported effects on pain from a similar telephone-based survey conducted on a sister product UlcerCare which demonstrated that 84.5% of the 160 respondents had a reduction in associated leg pain with UlcerCare. This reduction in pain was highly statistically significant, p < 0.0001. There was a statistically significant reduction in painkiller consumption after using UlcerCare (p< 0.030), with 57% of patient’s no longer taking painkillers at all.
These results taken together argue strongly for the ability of appropriately designed static magnets to effect pain relief to a significant degree.
The potential cost savings to the NHS are enormous both in terms of drug spending on analgesics as well as time saved in consultations or indeed in hospital admissions for treatment of patients with pain. This is all perhaps insignificant compared to the potential impact on patients’ lives that have chronic pain that is not well controlled by analgesics. This report demonstrates an impressively high level of impact on chronic leg pain with a significant proportion 65% reporting an improvement in quality of life after wearing LegCare.
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