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| A study to determine whether a static magnetic device can promote chronic leg ulcer healing were completed and published in the Journal of Wound Care Volume 14, Number 2 (Feb 2005). |
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"With the relatively few numbers of patients in the trial we were not expecting to observe such clear difference due to the magnetic device.... we felt that the results were of such potential importance that they merited publication at this stage. What is more significant is that these were all patients whose ulcers were failing to heal by other usual treatments".
Dr Nyjon Eccles (Lead clinician for the study).
Copies of the Journal of Wound Care are available for nurses by call our help line on 0117 9710 710 (office hours)
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A Survey to Determine the Effectiveness
of Magnopulse UlcerCare
on Leg Ulcer Healing and Leg pain |
Dr Nyjon. K. Eccles BSc MBBS PhD MRCP
& Derek. R. Price
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Contents
- Abstract
- Introduction
- Objectives
- Methods
- How many were helped by the Magnopulse device?
- How long did it take to notice improvement?
- Average Reduction in Ulcer size
- Ulcer size after treatment with UlcerCare
- Did UlcerCare reduce swelling?
- Average reduction in swelling with UlcerCare
- Was there a reduction in pain with UlcerCare?
- Further comments made by patients
- Summary and Conclusions
Abstract
A survey was conducted of 160 randomly selected users of Magnopulse UlcerCare static magnet leg wraps. Average ulcer duration was 49 months i.e. just over 4 years. The device had been worn for an average of 4 months at the time of the survey. The key findings were as follows:
A highly significant reduction (p < 0.0001) in ulcer size of 68% was achieved over the treatment period. Forty one percent (41%) of patients experienced complete ulcer healing with only 11% of patients had no effect on ulcer size. The average time to heal in those that had complete healing was 3.9 months.
Seventy two percent of those with associated swelling had a reduction in swelling after wearing UlcerCare with an average reduction in swelling of 71%. This reduction in swelling was highly statistically significant, p < 0.0001.
Eighty four and a half percent (84.5%) 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 patients no longer taking painkillers at all.
The majority, 54.5% reported an improvement in ability to perform daily tasks with 64% reported an improvement in the quality of life. This was at least in part due to less pain, less restriction and greater mobility.
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Introduction
In the field of medicine as a whole there has been a recent surge in interest by patients and physicians alike in the use of magnetic fields in the treatment of pain. Attraction of the lay healer, the over promotion and unscientific approach to study and aggressive claims have led to scepticism. New controlled studies have begun to change this stance. In a recent scientific review (Eccles, 2002) of 12 double-blind placebo-controlled studies 7 out of the 8 well-controlled studies demonstrate a positive effect of static magnets in pain relief.
Although well-controlled studies have been performed on the stimulation of bone growth by electric and magnetic fields, effects of magnetic fields on soft tissues remain unclear; they represent the next frontier in electromagnetic biology and medicine. Electrical and magnetic field have been associated with a number of demonstrable effects that are advantageous to wound healing such as increased collagen deposition, increased fibroblast migration, increased migration of macrophages and leucocytes leading to decreased bacterial counts, reduced sympathetically-mediated vasoconstriction, increased cellular oxygen delivery and increased wound epithelialization (Mann et al, 1999).
All electrical currents generate magnetic fields and all magnetic fields cause a change in electrical potential. Therefore, an interaction of magnetic fields with ion fluxes across the cell membrane is very likely.
Atoms are spinning magnets and therefore must interact with each other. It is logical to assume that magnetic fields can influence the charged state of biological systems (Adey, 1986). Living systems maintain magnetic profiles in the range of 10 ?7 Gauss to 10 ?12 Gauss. Faradays law states that a magnetic field will exert a force on a moving ionic current. Ionic currents across cell membranes are fundamental to maintenance of cellular integrity and cell communication. Ionic effects e.g. changes in ion binding have been described with magnetic fields as low as 0.1 to 1 microtesla (Muehsam & Pilla, 2000).
Healthy cells seem to have greater electrical charge than unhealthy cells (Owen, 1986). Cellular health and efficient function is to a large degree dependent on the maintenance of correct ionic gradients across the cell membrane. These ionic gradients are maintained by continuous inputs of energy. Most of the chemical energy of our body is used up to re-establish ion gradients, gradients that keep metabolic processes going, including signaling mechanisms. Important examples include Na/K transporters, which can either be antiporters, coupling the counter movement of Na and K ions across membranes, or symporters, moving Na+ and K+ synchronously and unidirectional to the same side of the membrane.
There is certainly evidence that electrical fields are a necessary component of amphibian limb regeneration (Borgens et al, 1977, 1979, 1979; Vanable et al, 1983). That electrical fluxes are important in healing in mammals is evident form studies on bone deformation. Compression of bone generates a negative electrical potential. Furthermore, the cells are responsive to alteration in externally applied DC electrical fields (Basset & Becker, 1962).
As long ago as 1792, Galvani observed that injured tissues generated small electrical currents. Becker measured these injury currents in bone and others have measured them in injured soft tissue (Wolcott et al, 1969).
Electrical stimulation has been used to facilitate wound healing for more than 30 years (Carey & Lepley, 1962). Two aspects of electric currents have potential to influence healing tissue 1). The ability of certain types of electric currents to attract oppositely charged particles and thus possibly enhancing the migration of cells like macrophages and fibroblasts. These effects are strongest when direct current is used (Wolcott et al, 1969). A current of injury is well described (Becker & Selden, 1985) that involves the flow of charged particles from uninjured to an injured site. Wounds failing to heal have been reported to display reduced levels of current of injury (Burr et al, 1938). As a wound heals the current of injury reduces as well. It is thought that externally-applied electrical currents are able to promote wound healing by augmenting the injury currents.2) Activation of cutaneous nerves may create a centrally-mediated increase in circulation (Kaada, 1982).
The greatest difficulty in evaluating efficacy of electrical current or electromagnetic stimulation for acceleration of wound healing is the variety of the parameters of the applied stimulation i.e. frequency, amplitude, signal shape, field gradients, duration of exposure etc. It is difficult to ascertain which parameters of the EM signal are responsible for the observed bio-effect. Of course with static magnetic fields there are less of these variables to consider.
The prevalence of active leg ulceration in the UK is 0.15-0.18% which represents 450 patients per health district of 250,000 population. There are estimated to be 100,000 ulcer patients in the UK. Seventy to 90% are venous in origin, 5-20% arterial, 10-15% combined and 5-10% due to other causes such as diabetes, vasculitis, neoplasm, infection, trauma etc. There is an increased prevalence with age so that the average of 1.5 to 1.8 per 1000 population rises to 3 per 1000 at age 61-70 and 20 per 1000 at age 80 and above. Nearly 1% of the population are affected by leg ulcers at some point in their lives. Over two thirds of leg ulcer sufferers have recurrence and a third have 4 or more episodes. Fifty percent of ulcers are open for 9-12 months, 20% are open for 2 years and 8% are open for more than 5 years. Sixty to 90% are managed in the community and this represents 8-22% of district nurse workload.
From an expenditure point of view it has been estimated that in the late 1980’s £100-120 million a year was being spent on ulcer care although other estimates put the figure much higher than this at £600 million per year. These estimates amount to between £1100 and £5000 being spent on each patient per year. For comparison, in the USA the annual cost of wound care has been estimated to be $3 billion annually (National Institutes of Health release, Oct 2000).
Clearly, chronic ulceration is a problem and a major financial burden on the NHS.
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Objectives
The purpose of this survey was to assess the extent of the effectiveness of UlcerCare, a static magnet product that is commercially available for the treatment of leg ulcers. There has been an accumulating wealth of anecdotal evidence of its effectiveness to promote ulcer healing. 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 in promoting leg ulcer healing.
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Methods
A questionnaire survey was conducted by telephone of 160 randomly selected UlcerCare users. Verbal consent was obtained and also consents for the data to be used as part of a scientific analysis to assess the efficacy of the products. No exclusions were made on the basis of age or sex or on the basis of location. No incentives were offered to those taking part in the survey. The product is registered as a Class 1 Medical Device.
UlcerCare and LegCare Description
The UlcerCare and LegCare wrap contains powerful neodymium magnets. Each magnet has patented and unique directional plates that allow the negative enhanced magnetic field to be absorbed deeper into the tissues; it is thought that this gives more effective and longer lasting effect. The leg wrap should be worn as much as possible (including overnight). The wraps are fitted below the knee and above the calf muscle and are held in place by Velcro fastenings. The leg wraps are double lined for comfort, and are adjustable and washable.
The product is registered as a Class 1 Medical Device.
Magnopulse quote on the product information” Leg Wraps were developed on the principle that most injuries will heal naturally if your body can supply enough oxygen and nutrients to the affected area. We believe the high success of the Leg Wrap is due to improved blood flow. In most cases this will help those with ulcers and leg problems to heal naturally without the use of drugs”.
Statistical Analyses
For all the comparisons below the parametric t-test is used, as the sample size is sufficiently large. In particular, for the comparisons of the reduction in pain, swelling or ulcer size with regard to the baseline value a one-sample t-test is used while for the comparisons between males and females the two-sample t-test is employed. Finally, in order to compare the number of painkillers taken before and after UlcerCare a paired t-test is used. For all hypothesis tests a 5% significance level (p<0.05) and two-tailed tests are taken.
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How many were helped by the Magnopulse device?
- 74% of patients were helped by the device
- Percentage response to question = 100
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How long did it take to notice improvement?
- Average time to notice improvement - 3.2 weeks
- Range of time Less than 1 week to 12 weeks
- Percentage response to question = 92
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Average Reduction in Ulcer size
- Percentage patient response to question = 96
- Average reduction in ulcer size was 68% over the treatment period
- This reduction in ulcer size as highly statistically significant, p < 0.0001 (95% confidence intervals 6.08 to 7.45)
- There was an almost significant greater reduction in ulcer size in males than in females (p= 0.053, 95% confidence intervals 0.021 to 2.74)
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Ulcer size after treatment with UlcerCare
- 41% of patients had complete ulcer healing.
- 11% of patients had no effect on ulcer size.
- This represents a positive response rate of 89%.
- Percentage patient response to question = 96
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Did UlcerCare reduce swelling?
- 58% of patients said they had associated swelling. This represented 67 patients.
- 67 patients i.e. 100% of those who had swelling responded to the question.
- 72% of those with associated swelling had a reduction in swelling after wearing UlcerCare.
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Average reduction in swelling with UlcerCare
- Percentage of response to the question from those who had swelling 76
- There was an average 71% reduction in swelling after wearing UlcerCare
- This reduction in swelling is highly statistically significant, p < 0.0001 (95% confidence intervals 6.35 to 7.93)
- There was a small but statistically greater reduction in swelling in males than in females (p< 0.029, 95% confidence intervals 0.2 to 3.4).
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Was there a reduction in pain with UlcerCare?
- Percentage of patients responding to question 71
- 84.5% had a reduction in associated leg pain with UlcerCare
- This reduction in pain is highly statistically significant, p < 0.0001
- There was no significant difference in pain reduction between male and female patients (p=0.548, 95% confidence intervals 0.91 to 1.71)
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Further comments made by patients
“Also stopped cramps in legs”
“My legs are no longer painful since using the wrap”
“I have ordered more”
“It was recommended by my nurse”
“Started working straight away”
“Seems the ulcer is getting shallower”
“Ulcers have continued”
“I am very pleased”
“I would recommend this to others”
“The wrap has increased the healing”
Not everyone made a comment but those who did are shown above.
The vast majority of comments made were positive
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Summary and Conclusions
Fifty six percent of patients surveyed were male and 44% were female. In general the response rate to questions was good, usually 75% and more.
Average ulcer duration was 49 months i.e. just over 4 years (Range <1 to 504 months).
The majority (81%) of leg ulcers were anterior in position and 76% had associated leg pain with 58% having associated leg swelling. The average duration of wear of the device at the time of survey was 4 months (Range 1 to 6 months).
Within this time the device had helped 74% of patients. The average time to notice improvement was 3.2 weeks (Range, < 1 week to 12 weeks). Average reduction in ulcer size was 68% over the treatment period.
This reduction in ulcer size was highly statistically significant, p < 0.0001 (95% confidence intervals 6.08 to 7.45). There was a greater reduction (almost significant) in ulcer size in males than in females (p= 0.053, 95% confidence intervals 0.021 to 2.74).
Forty one percent of patients experienced complete ulcer healing with only 11% of patients had no effect on ulcer size indicating a dramatic response rate of 89%. The average time to heal in those that had complete healing was 3.9 months (Range 0.5 to 18 months).
Seventy two percent of those with associated swelling had a reduction in swelling after wearing UlcerCare with an average reduction in swelling of 71%. This reduction in swelling was highly statistically significant, p < 0.0001 (95% confidence intervals 6.35 to 7.93).
There was a small but statistically greater reduction in swelling in males than in females (p< 0.029, 95% confidence intervals 0.2 to 3.4). Eighty four and a half percent (84.5%) had a reduction in associated leg pain with UlcerCare. This reduction in pain was highly statistically significant, p < 0.0001.
There was no significant difference in pain reduction between male and female patients (p=0.548, 95% confidence intervals 0.91 to 1.71). Regarding consumption of painkillers, disappointingly few patients responded adequately to this question but the reduction in painkillers taken after using UlcerCare was statistically significant (p< 0.030, 95% confidence intervals 0.088 to 1.65) and 57% of patients were no longer taking painkillers at all.
The majority, 54.5% reported an improvement in ability to perform daily tasks with 64% reported an improvement in the quality of life. This was at least in part due to less pain, less restriction and greater mobility.
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.
This survey, conducted randomly on 160 Magnopulse UlcerCare users has demonstrated marked statistically significant trends in favour of chronic leg ulcer healing and reduction of leg pain and associated leg swelling. A double blind placebo controlled trial is currently underway to examine the effect of the UlcerCare static magnets in ulcer healing; the results of which are expected before the end of 2003.
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Magnopulse Help-Line 0117 9710 710 (office hours) Office hours only.
To Purchase the the Magnopulse Ulcercare online Click Here
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