Also in respect to the Magnetic Field Generator the BEaMEr is the result of years of experience with the Health Navigator (of which I attach part of the documentation for its medical certification).

Magnetic therapy has shown great efficacy for tendon and muscle healing, Osteoarthrosis, wound and pain reduction. But as with all other therapy forms that are possible with the BEaMEr the key difference to all other existing devices and methods is the  fact that therapy is possible 24/7 and this will prove to make a big difference in effectiveness. 

With the BEaMEr it is possible to create Interference pulsed magnetic Therapy and in case of setting the 2nd channel in Inversion mode the condition is realized to at least partially create Scalar Energy – this will be part of further research.

 

Clinical Evaluation:

Use of the

Health Navigator

in Magnetic Field Therapy

Evaluation according to Annex X of Directive 93/42/EEC and in Consideration of

MEDDEV 2.7.1, Version April 2003

 

 

 

Contents

1 Introduction………………………………………………………………………………………………………..4

2 Product Description…………………………………………………………………………………………….4

3 Purpose………………………………………………………………………………………………………………4

3.1 Magnetic Field Therapy – Background Information……………………………………….4

4 Classification ……………………………………………………………………………………………………..4

5 Clinical Data ……………………………………………………………………………………………………..5

5.1 Literature Research ………………………………………………………………………………………….5

5.2 Literature Analysis……………………………………………………………………………………………6

5.3 Indications……………………………………………………………………………………………………….6

5.3.1. Bone Healing……………………………………………………………………………………..6

5.3.2. Osteoarthroses…………………………………………………………………………………….8

5.3.3. Tendinopathies……………………………………………………………………………………9

5.3.4 Inflammatory Disorders of the Musculoskeletal System………………………….10

5.3.5. Pain Therapy…………………………………………………………………………………….10

5.3.6. Wound Healing…………………………………………………………………………………10

5.3.7. Spasticity………………………………………………………………………………………….11

5.3.8. Conclusions ……………………………………………………………………………………..11

5.4 Contraindications, Restrictions of Use, Adverse Effects………………………………………12

5.5 Preclincal / Technical Testing ………………………………………………………………………….12

5.6 Market Monitoring………………………………………………………………………………………….12

6. Benefit / Risk Assessment…………………………………………………………………………………13

7. Summary…………………………………………………………………………………………………………13

8. References……………………………………………………………………………………………………….14

8.1. List of References……………………………………………………………………14

 

1          Introduction

To prove the suitability of the Health Navigator for the purpose and field of application described by the manufacturer, a clinical evaluation is required as part of the conformity assessment procedure according to Annex I of the Directive 93/42/EEC, Section 1 and 3.

The execution of clinical evaluations of medical devices is regulated in MEDDEV 2.7.1 of April 2003. Clinical performance and safety of the medical device must be verified based on clinical data and relevant literature compilation.

2          Product Description

The Health Navigator is used together with CE compliant magnetic field applicators. The magnetic filed applicators produce magnetic field strengths of maximal 4 to 36 mT.

3          Purpose

The Health Navigator is used in magnetic field therapy (MFT) as therapeutic device. Magnetic field therapy is used in the fields of bone healing, pain reduction, wound healing and for tendinopathies.

3.1       Magnetic Field Therapy – Background Information

Magnetic field therapy is an ancient physical therapy modality and the effects of permanent and low frequency pulsating electromagnetic fields (PEMF) has been a subject of medicine science for 2000 years. Magnetic field therapy is recommended for a variety of diseases. So far positive effects of magnetic field therapy could be found in several randomized studies for bone healing, wound healing and as analgesic for degenerative joint diseases. Unfortunately no precise recommendations concerning therapy duration and intensity can be provided due to lack of data. Electromagnetically induced alternate fields („pulsed electromagnetic fields“, PEMF) have been used as adjuvant method to stimulate bone healing for several decades. In numerous experimental studies several possible active mechanisms could be demonstrated. In clinical settings PEMF is used to support bone healing, in osteotomies, callus distractions, spondylodesis surgery, arthrodeses or the therapy of delayed bone fracture healing or pseudarthrosis of long bones. Advantages of PEMF therapy are a lack of adverse effects and the possibility to use this non-invasive technology as an additional method to increase the chances of healing for problem patients.

4          Classification

The Health Navigator is a medical device according to Article 1 (2) (a) MDD because it is intended to be used for diagnosis, prevention, monitoring and treatment of diseases and does not achieve its principal intended effect by pharmacological, immunological or metabolic means.

The Health Navigator is classified as class IIa medical device according to Annex IX of the MDD, Rule 9 (active therapeutic devices).

5          Clinical Data

5.1       Literature Research

Several search runs were conducted in the publicly available literature database PubMed (National Library of Medicine) from October 15 to 31, 2008 with the search term “magnetic field therapy“.

The following inclusion and exclusion criteria were used:

– literature sources in German or English

– abstract present

– only results from human studies

– literature evaluating the aspects effectiveness and safety; no economical aspects

– level of evidence greater than or equal to IIb

Classification of evidence:

 

(Source: Classification of evidence http://www.leitlinien.de/leitlinienqualitaet/manual/index/kap05recherche/view)

In addition to the search in PubMed, searches with the search term “magnetic field therapy“ were conducted in the search engines Google and Google Scholar.

5.2       Literature Analysis

After applying the inclusion and exclusion criteria, the search produced 45 literature sources (see chapter 8). The article of Quittan et al. (2000) is a review article with the highest level of evidence (Ia). Literature sources from later than the year 2000 were evaluated regarding new or contradictory indications.

5.3       Indications

5.3.1   Bone Healing

In a review study on magnetic field therapy for poor bone healing after tibia fractures Gossling identified 44 published works. He reports an overall healing rate of 81 % with pulsating electromagnetic fields (PEMF) compared to 82 % with surgical intervention (18 in Q#1). In treatment of infected pseudoarthrosis the success rate of 69 % with PEMF is favorable compared to 21 % with surgical intervention. For pseudoarthosis of the tibia PEMF therefore seems to be more successful than other conventional therapy attempts and is considered as at least equal to surgical therapy.

A total of 5 controlled studies on the effect of PEMF on the healing rate of tibia fractures can be identified. The study by Sharrard (32 in Q#1) is described very thouroghly. 45 patients were included in a double-blind placebo-controlled and randomized design. A pulsed magnetic field of 15 Hz was applied over 12 weeks for 12 hours per day. Unfortunately there are no records regarding the dosage of the field strengths. In the radiological evaluation by a radiologist and an orthopedist, as well as in the clinical evaluation of the fracture healing, a healing rate of 45 % was shown with PMEF compared to 12 % with placebo treatment. Among the four other controlled studies one study showed no advantage of magnetic field therapy compared to sham therapy (3 in Q#1). However, this study includes only a small number of cases with an uneven distribution of fracture severity.

The remaining three controlled studies show superiority of PEMF therapy compared to a surgically treated control group (6, 13, 15 in Q#1). This indication group of PEMF also includes a study by Mooney (25 in Q#1) on the healing rate after spine surgery (lumbar interbody fusion). 195 patients were enrolled in a double-blind, randomized and placebo-controlled design after a “lumbar interbody fusion” had been performed. A very weak pulsed magnetic field with a flow density of 1.8 G and a frequency of 1.5 Hz was compared to placebo treatment. An assimilation of the fusion of more than 50% was defined as endpoint. The treatment time was 8 hours per day, the observation period was 6 weeks. The success rate in the therapy group was 92 % compared to 65 % in the control group.

The healing rate after tibial osteotomy due to degenerative knee joint arthrosis and the impact of PEMF was investigated by Mammi (24 in Q#1). 40 patients were enrolled in a randomized, placebo-controlled and double-blind design. The verum group received a magnetic field of an intensity of 3.3 mV, 75 Hz, 8 hours per day. The overall treatment duration was 60 days. The radiological evaluation of the osteotomy healing showed a significant advantage of magnetic field therapy compared to placebo therapy (sham therapy).

The healing rate after intertrochanteric osteotomy due to degenerative hip joint arthrosis was investigated in a study by Borsalino (8 in Q#1). A statistically significant advantage of increased callus formation after 40 and 90 days was shown in this double-blind, placebo-controlled and randomized design with 32 patients as well. The dosage of the applied magnetic field was 18 G, 75 Hz with a treatment time of 8 hours per day over a total of 3 month. The effectiveness of PEMF as therapy of a loose cemented hip endoprothesis was investigated by Kennedy (21 in Q#1). A magnetic field of 15 Hz was applied to the relevant hip for 8 hours daily, the overall treatment duration was 6 months. No information about the intensity of the magnetic field is available. The Harris Hip Score was used as target parameter. Immediately after the end of the treatment, i.e. after 6 months, a significantly improved score could be observed in the verum group compared to the placebo group. The therapeutic effect lasted for another 6 months. After the total observation time of 36 month no more difference between the two groups could be seen.

A controlled, but not randomized, study on osteonecrosis of the femur head by Aaron (1 in Q#1) is available. 160 hips were treated either with pulsed magnetic field or by surgical decompression. The treatment duration was 12 to 18 months with a PEMF frequency of 72 Hz and a the treatment time of 8 hours per day. No information about the flow density is available. The control group received a surgical decompression of the femur head. Based on clinical and radiological data, progression decrease could be shown in both groups with advantages for the magnetic field therapy. The positive effect of the magnetic field with a success rate of 87 % compared to 62 % with surgery was especially obvious in Ficat II lesions.

The effect of pulsed magnetic field therapy on the healing rate of “host graft junctions” after bone resection due to tumors was reviewed in a double-blind, randomized and placebo-controlled study. A pulsed magnetic field of 75 Hz was applied over up to 12 month for 8 hours per day. The healing time was diminished significantly from 9.4 months in the control group to 6.7 months in the verum group (10 in Q#1).

32 patients with a metatarsus primus varus on both sides were subjected to a osteotomy of the first metatarsal bone with subsequent osteosynthesis. The left foot was postoperatively exposed to an electromagnetic field, the right foot served as control. The treatment regime consisted of daily one-hour magnetic field treatment with an intensity of 50 G, a frequency of 10 Hz and an overall treatment duration of 12 weeks. As a result significantly faster callus formation occurred in 56 % of the patients, a moderately accelerated callus formation occurred in another 15 %. Target parameter was a combined point score of clinical and radiological parameters (19 in Q#1).

Summarizing, 12 controlled studies on the effect of pulsed low frequency magnetic fields on bone healing were found. 11 of these studies confirm the clinical effectiveness with regard to faster and improved bone healing. Although various magnetic flow densities and frequencies were used, a long daily treatment duration of 8 to 12 hours is in common to all studies. This can only be realized by attaching small coils to the body in the desired position.

Degenerative Diseases of the Musculoskeletal System

5.3.2   Osteoarthroses

Well designed studies on degenerative cervical and lumbar spine syndromes, on knee and hip joint arthrosis and on tendinopathy in the shoulder and elbow joint areas.

Trock et al. investigated the effectiveness of PEMF on joints with degenerative changes (36, 37 in Q#1) in 2 studies. Inclusion criteria were patients with osteoarthrosis of the knee joint or the cervical spine. 86 patients with gonarthrosis and 81 patients with osteoarthrosis of the cervical spine were included in a multicenter double-blind placebo-controlled and randomized design. The patients received 18 treatments of a duration of 30 minutes each. Pain reduction of 26.5 % compared to the baseline was observed in the verum group for gonarthrosis, and of 11.9 % in the placebo group. For osteoarthrosis of the cervical spine the decrease was 27.8 % and 16.3 % respectively. Compared to the placebo group the combined data of both diagnosis groups also showed significant improvements in the verum group after one month, especially with regard to pain and passive joint mobility.

A high number of patients with various degenerative diseases of the musculoskeletal system (epicondylitis, coxarthrosis, gonarthrosis, ischialgia, lumbago and adhesive capsulitis) were treated with a pulsed magnetic field in a placebo-controlled study (27 in Q#1). 20 minutes of therapy per day were performed with a flow density of 25 mT and a frequency of 50 to 60 Hz, the overall treatment time was 2 hours. The target parameter pain improved, especially in the verum group, with the patients with gonarthrosis reporting especially pronounced pain reduction.

These results could not be verified in another randomized crossover study which included 92 patients with chronic cervicovertebral syndrome. A combination therapy of physiotherapy with magnetic field or sham magnetic field, respectively, did not show better results in combination with additional verum magnetic field therapy (31 in Q#1).

One study investigated the effect of different therapy combinations on a homogenous patient population with confirmed coxarthrosis (33 in Q#1). 120 patients, randomized in 4 groups, received a base therapy of either physiotherapy only or in combination with either short wave, pulsed magnetic field or sham magnetic field. The evaluation of the target parameter “rheuma-number and measuring index” showed significantly better results for the combination therapy of physiotherapy and short wave.

5.3.3. Tendinopathies

Two controlled and randomized studies are available on tendinopathy of the rotor cuff. In the study by Ammer (2 in Q#1) a significantly functionally better result (less pain when moving against resistance) was observed in the verum group, but that was made relative by additional higher analgesic use in the verum group.

In a multi phase study, partly executed in crossover design, Binder (7 in Q#1) showed a significantly better effectiveness of PEM regarding pain in therapy (steroid infiltrations) refractory rotor cuff tendinopathy.

A combination of physiotherapy and warm wraps was also used for therapy of shoulder periarthropathy. Base therapy was the same for all patients. In addition the control group received a sham magnetic field therapy, and the verum group PEMF (22 in Q#1). 47 patients were included in the study, the overall treatment duration was 12 weeks. At therapy end no significant difference for pain parameters (visual analogous scale), the range of motion or the functional status of the affected shoulder joint was found. However, it must be said that all patients received physical base therapy and there probably was a bias.

30 patients with chronic humero-radial epicondylitis were randomized in a verum and a placebo group. In the verum group a pulsed magnetic field with a field strength of 13.5 mV and a frequency of 15 Hz was applied. Treatment was given for 12 weeks at an average of 8 hours per day. Both groups had improved grip strength and a better thermographic quotient. The improvement in the verum group tended to be more definite but did not reach a relevant significance level (14 in Q#1).

Hong (20 in Q#1) subjected 101 patients with chronic cervical syndrome to magnetic field therapy with a constant flow density of 1,300 G. Therapy was performed over 3 weeks for 24 hours a day. 52 of the patients experienced pain, 49 were pain-free. The patients were randomized in 4 groups so that one of each group with and without pain received verum or placebo therapy respectively. Pain reduction was observed in the verum as well as in the placebo group with an advantage for the verum group. In addition a significant reduction of the proximal nerve conducting velocity of the nervus ulnaris through the magnetic field was observed for the patients without pain but not for the patients with pain.

Summarizing, the studies found on the effects of magnetic fields on degenerative joint and tendon diseases yielded mixed results. The results of 5 of the 8 evaluated studies regarding degenerative musculoskeletal diseases were positive, especially with regard to pain. The majority of the designs of the studies were very good but did not seem to influence the result. It seems more likely that the treatment time per day has an impact on treatment success. Especially in therapy for tendinopathy, for example, 2 of 3 negative studies used treatment times of only 15 to 30 minutes per day (2, 22 in Q#1). In part small flexible coils worn on the body are used to generate the magnetic field here as well.

5.3.4   Inflammatory Disorders of the Musculoskeletal System

24 patients with confirmed ankylosing spondylitis were treated with a sinusoidal magnetic field or a placebo therapy in a controlled crossover study design. The treatment time was set to 30 minutes per day. After 4 weeks the groups were crossed over, the overall evaluation was conducted after an additional 4 weeks. Both groups together showed a 10 to 15 % decrease of pain intensity and mobility restriction without significant advantage for the verum group (30 in Q#1).

5.3.5. Pain Therapy

In a recent study highly significant pain reduction could be achieved in patients with post-poliosyndrome by applying a constant magnetic field with a flow density of 300 to 500 g once (38 in Q#1). The study included 50 patients with musculoskeletal pain. The design was double-blind and placebo-controlled. Using the McGill Pain Questionnaires a pain reduction of 16 % in the verum group and of 19 % in the control group could be documented. The permanent magnets were worn over the painful area for 45 minutes.

The effect of additional PEMF on neuromuscular electrostimulation of the knee extensor muscles after reconstruction of the cruciate ligament was investigated in a study by Currier (11 in Q#1). The authors found decreased sensible discomfort by neuromuscular electrostimulation when a pulsed electromagnetic field of 60 Hz was applied simultaneously. By using a high field strength of 1.5 T additional nerve depolarisation occurred. In this way a stronger muscle contraction was triggered than by neuromuscular electrostimulation alone. Deficiencies of the study are the low case number of 17 patients and the lack of randomization.

5.3.6. Wound Healing

2 studies are concerned with the impact of a pulsed magnetic field on ulcer healing. Stiller et al. (34 in Q#1) conducted PMEF therapy on 31 patients with venous leg ulcers for 3 hours each day. After 8 weeks the authors could demonstrate a significant advantage compared to the control group in wound depth and size as well as pain. Furthermore improved granulation was observed at the ulcer base. The design of the study was double-blind, placebo-controlled and randomized. The study of Todd et al. (35 in Q#1) came to the opposite conclusion and did not find any size difference in leg ulcers compared to the placebo group after 5 weeks of magnetic field therapy. However, the randomization of the groups is not clearly evident and the number of 19 patients is smaller than in the study by Stillen.

Indian patients with ulcers of leprous origin were treated with a magnetic field of 2400 nT during 4 weeks with 1 Hz. The study was double blind, randomized and placebo controlled. The therapy over 4 weeks caused a significant reduction of the occurrence of ulcers (29 in Q#1).

5.3.7. Spasticity

The influnece of magnetic stimulation on the extent of spasticity in patients with multiple sclerosis was investigated by Nielsen (26 in Q#1). This study was blind, placebo controlled and randomized as well. Stimulation was externally carried out twice a day for 25 minutes above the bone marrow at a height of Th 8 with an intensity of 1.2 T and a frequency of 25 Hz. The verum group showed a reduction of spasticity according to the Ashworth scale and a significant increase of the excitability threshold of the strech reflex. Already a pulsed magnetic field of this strength evokes a depolarization of excitable structures. For example, the patients of the verum group experienced a definite contraction of the back muscles. In the control group the magnetic field was weakened to the extend that depolarisation could not be triggered anymore.

5.3.8. Conclusions

A total of 31 studies with at least controlled design could be found regarding the clinical effectiveness of magnetic fields. 20 studies had a double-blind, placebo-controlled design. 15 of the studies confirm the positive effectiveness of magnetic fields, especially in the area of bone healing and pain reduction in joint diseases on degenerative basis. However, for tendinopathies only 1 of 4 studies could describe an effect surpassing the placebo effect.

The flow densities used with pulsed magnetic fields were between 2 and 100 G (0.2 mT to 10 mT), the frequencies were between 12 and 100 Hz. A therapeutical superiority of certain flow densities or frequencies could not been derived from the available studies.

The application time ranged from 15 minutes to 24 hours per day and lasted 3 weeks to 18 month. A tendency of shorter treatment times was noted for negative studies. Generally the number of available studies is too low to make a valid statement regarding the dose-effect relationship.

Therapy with pulsed magnetic fields seems to be a clinically effective but time consuming method to influence bone healing.

5.4       Contraindications, Restrictions of Use, Adverse Effects

The scientific articles excluded from thorough evaluation were analyzed with regard to adverse effects, complications and contraindications. Furthermore the Internet was searched for evidence.

Magnetic field therapy can cause tingling and a sensation of warmth in the treated area. During or after therapy restlessness, palpitations, sweating and anxiety can occur.

During pregnancy magnetic field treatment should not be performed due to unknown risks for the development of the unborn child.

Patients with electric implants like pace makers should not be treated with magnetic field therapy.

5.5       Preclincal / Technical Testing

In order to ensure the safety of the product the following standards were adhered to during product realization:

• DIN EN 60601-1 (Medical Electrical Equipment – Part 1: General requirements for safety and essential performance)
• DIN EN 60601-1-2 (General requirements for safety and essential performance -Collateral standard: Electromagnetic compatibility)
• DIN EN 60601-1-6 (Medical Electrical Equipment – Part 1-6: General requirements for safety and essential performance -Collateral standard: Usability)
• DIN EN ISO 10993-1 (Biological evaluation of medical devices- Part 1: Evaluation and testing)

5.6       Market Monitoring

Systematic overviews regarding complications could not be found.

The American Food and Drug Administration (FDA) does not list entries for „magnetic field therapy“ in their database MAUDE „Manufacturer and User Device Experience“. The data are not intended to evaluate the frequency of side effects.

The scientific articles excluded from thorough evaluation were analyzed with regard to side effects, complications and contraindications. No evidence was found in literature sources.

6.         Benefit / Risk Assessment

Based on the evaluated literature therapeutic effectiveness of magnetic field therapy could been shown.

When used properly, risks can be considered to be low. Magnetic field therapy is suitable to treat bone fractures (bone healing), to reduce pain, for wound healing and for tendinopathies. Therefore the benefit / risk assessment is positive.

7          Summary

A clinical evaluation was conducted for the Health Navigator as part of the conformity assessment procedure to prove its suitability for the purpose and field of application described by the manufacturer according to Annex I of Directive 93/42/EEC, Section 1 and 3. The clinical evaluation was conducted according to guideline MEDDEV 2.7.1 of April 2003.

A benefit / risk assessment of magnetic field therapy was conducted. Magnetic field therapy is suitable to treat bone fractures (bone healing), to reduce pain, for wound healing and for tendinopathies. The benefit of magnetic field therapy is greater than possible risks, therefore the benefit / risk assessment is positive.

8          References

Magnetic Field Therapy

Barker, A. T.; Dixon, R. A.; Sharrard, W. J.; Sutcliffe, M. L. (1984): Pulsed magnetic field therapy for tibial non-union. Interim results of a double-blind trial. In: Lancet, Jg. 1, H. 8384, S. 994–996.

Abstract         Patients with tibial fractures which had remained un-united for at least 52 weeks were randomly allocated to either active or dummy pulsed magnetic field stimulators and treated in full leg plasters for 24 weeks with a nonweightbearing conservative regimen, as is usual with such techniques. Fractures in 5 of the 9 patients with working machines united and fractures in 5 of the 7 patients with dummy machines also united. These early results of this double-blind trial are compatible with a difference in success rate at 24 weeks on active treatment of + 33% to -61% (95% confidence limits) compared with the success rate on the dummy stimulators. The high proportion of fractures uniting in the control group suggests that conservative management of non-union is effective and this may explain much of the success attributed to pulsed magnetic field therapy.

Category        2 Ib – RCT

 

Brown, C. S.; Ling, F. W.; Wan, J. Y.; Pilla, A. A. (2002): Efficacy of static magnetic field therapy in chronic pelvic pain: a double-blind pilot study. In: American journal of obstetrics and gynecology, Jg. 187, H. 6, S. 1581–1587.

Abstract         OBJECTIVE: The aim of the study was to determine the efficacy of static magnetic field therapy for the treatment of chronic pelvic pain (CPP) by measuring changes in pain relief and disability.STUDY DESIGN: Thirty-two patients with CPP completed 2 weeks and 19 patients completed 4 weeks of randomized double-blind placebo-controlled treatment at a gynecology clinic. Active (500 G) or placebo magnets were applied to abdominal trigger points for 24 hour per day. The McGill Pain Questionnaire, Pain Disability Index, and Clinical Global Impressions Scale were outcome measures. RESULTS: Patients receiving active magnets who completed 4 weeks of double-blind treatment had significantly lower Pain Disability Index (P <. 05), Clinical Global Impressions-Severity (P <.05), and Clinical Global Impressions-Improvement (P <.01) scores than those receiving placebo magnets, but were more likely to correctly identify their treatment (P <.05). CONCLUSION: SMF therapy significantly improves disability and may reduce pain when active magnets are worn continuously for 4 weeks in patients with CPP, but blinding efficacy is compromised.

Category 2 Ib – RCT

 

Callies, R. (1991): Fortschritte der Physikalischen Therapie des Schmerzes in der Rheumatologie.; Advances in the physical therapy of pain in rheumatology. In: Schmerz, Jg. 5, H. Supplement 1, S. S72-9.

Abstract         The analgesic effectiveness of physical therapy in rheumatology is dependent on the differentiated clinical picture (joint, soft parts, spinal column, musculature) and on the differentiated therapeutic remedy (intensity, duration of single treatments, frequency, duration of therapeutic series). Physico-and kinesitherapy can be distinguished with regard to objective and subjective doses; manual therapy is between them. During the last decade, particular advances were achieved in the field of medical gymnastics (muscular stretching technique), patients’ schools (back school) and of cryotherapy (cold-air therapy). The pulsed high-frequency therapy and particularly laser therapy, magnetic-field therapy and high-voltage therapy are critically judged. The problem “rheumatism and pain” mainly exists at the level of “chronic”; diagnostics of movement function (articular and muscular functions) on one hand and dosage of therapeutic remedies (drugs and remedies of physiotherapy) on the other are the guidelines. Course (rehabilitation) as well as onset (prevention) of rheumatic clinical pictures determine the further strategy of pain therapy.

Category        6 IV – Expert Opinion

 

Canapp, D. A. (2007): Select modalities. In: Clinical techniques in small animal practice, Jg. 22, H. 4, S. 160–165.

Abstract Physical rehabilitation modalities such as therapeutic ultrasound (TU), transcutaneous electrical neuromuscular stimulation (TENS), neuromuscular electrical stimulation (NMES), cold or low-level laser therapy (LLLT), and pulsed magnetic field therapy (PMF) can all, when used properly, assist in treating orthopedic injuries, neurological conditions, and chronic conditions brought about by normal aging in our small animal companions. TU uses sound waves to produce both thermal and nonthermal effects that aid in tissue healing, repair, and function. TENS uses different frequencies of electrical current to decrease pain and inflammation. NMES also uses an electrical current to stimulate muscle contraction to assist in normal neuromuscular function in postorthopedic and neurological injuries. LLLT uses light energy to reduce pain, decrease inflammation, and stimulate healing at a cellular level. PMF uses magnetic field to stimulate normal cellular ion exchange and oxygen utilization and promote generalized healing of tissues. These modalities are discussed in detail covering mechanism of action, parameters, settings, and indications/contraindications of use in our small animals. Although these modalities are important in the physical rehabilitation of small animals, they need to be incorporated with a proper diagnosis, manual therapy, and home exercise program into a specific and individualized patient treatment protocol.

Chorazy, M.; Monka, P.; Ramos, P. (2000): Skutecznosc terapii impulsowym polem magnetycznym po drenazu zewnetrznym zmian torbielowatych jamy brzusznej diagnozowanych ultrasonograficznie i izotopowo.; Efficacy of the impulse magnetic field therapy in patients after the outer drainage of abdominal cysts diagnosed with the use of isotopic and ultrasound techniques. In: Wiadomosci lekarskie, Jg. 53, H. 1-2, S. 35–38.

Abstract         154 patients with pancreatic, renal or hepatic cysts have been treated with the outer drainage under USG monitoring. Because of cysts’ contact with tracts penetrating to an organ or its lack, the patients have been divided into two groups. Directly after the puncture all the patients have undergone the high frequency impulse magnetic field therapy. A distinct, positive treatment effect has been found in patients who have gone through not only drainage, but also magnetic field.

 

Colbert, A. P.; Markov, M. S.; Souder, J. S. (2008): Static magnetic field therapy: dosimetry considerations. In: Journal of alternative and complementary medicine, Jg. 14, H. 5, S. 577–582.

Abstract         The widespread use of static magnetic field (SMF) therapy as a self-care physical intervention has led to the conduct of numerous randomized controlled trials (RCTs). A recent systematic review of SMF trials for pain reduction concluded that the evidence does not support the use of permanent magnets for pain relief. We argue that this conclusion is unwarranted if the SMF dosage was inadequate or inappropriate for the clinical condition treated. The purpose of this communication is to (1) provide a rationale and an explanation for each of 10 essential SMF dosing parameters that should be considered when conducting trials of SMF therapy, and (2) advocate for the conduct of Phase I studies to optimize SMF dosimetry for each condition prior to implementing a large-scale RCT. A previous critical review of SMF dosimetry in 56 clinical studies found that reporting SMF dosages in a majority of those studies was of such poor quality that the magnetic field exposure at the target tissue could not be characterized. Without knowing what magnetic field actually reached the target, it is impossible to judge dosage adequacy. In order to quantify SMF exposure at the site of pathology (target tissue/s), that site must be clearly named; the distance of the permanent magnet surface from the target must be delineated; the physical parameters of the applied permanent magnet must be described; and the dosing regimen must be precisely reported. If the SMF dosimetry is inadequate, any inferences drawn from reported negative findings are questionable.

Category        1 Ia -Meta-Analysis

 

Colbert, A. P.; Wahbeh, H.; Harling, N.; Connelly, E.; Schiffke, H. C.; Forsten, C. et al. (2007): Static Magnetic Field Therapy: A Critical Review of Treatment Parameters. In: Evidence-based complementary and alternative medicine.

Abstract         Static magnetic field (SMF) therapy, applied via a permanent magnet attached to the skin, is used by people worldwide for self-care. Despite a lack of established SMF dosage and treatment regimens, multiple studies are conducted to evaluate SMF therapy effectiveness. Our objectives in conducting this review are to:(i) summarize SMF research conducted in humans; (ii) critically evaluate reporting quality of SMF dosages and treatment parameters and (iii) propose a set of criteria for reporting SMF treatment parameters in future clinical trials. We searched 27 electronic databases and reference lists. Only English language human studies were included. Excluded were studies of electromagnetic fields, transcranial magnetic stimulation, magnets placed on acupuncture points, animal studies, abstracts, posters and editorials. Data were extracted on clinical indication, study design and 10 essential SMF parameters. Three reviewers assessed quality of reporting and calculated a quality assessment score for each of the 10 treatment parameters. Fifty-six studies were reviewed, 42 conducted in patient populations and 14 in healthy volunteers. The SMF treatment parameters most often and most completely described were site of application, magnet support device and frequency and duration of application. Least often and least completely described were characteristics of the SMF: magnet dimensions, measured field strength and estimated distance of the magnet from the target tissue. Thirty-four (61%) of studies failed to provide enough detail about SMF dosage to permit protocol replication by other investigators. Our findings highlight the need to optimize SMF dosing parameters for individual clinical conditions before proceeding to a full-scale clinical trial.

Category        5 III –descriptive Study

 

Degen, I. L. (197011): Lechenie travmaticheskikh otekov magnitnym polem.; Magnetic field therapy of traumatic edema. In: Ortopediia travmatologiia i protezirovanie, Jg. 31, H. 11, S. 47–49.

 

Dortch, A. B.; Johnson, M. T. (2006): Characterization of pulsed magnetic field therapy in a rat model for rheumatoid arthritis. In: Biomedical sciences instrumentation, Jg. 42, S. 302– 307.

Abstract         Recent studies have shown that pulsed magnetic fields (PMF) provide a practical, exogenous method for inducing cell and tissue modifications, as therapy for selected pathological states. A number of clinical studies, in vivo animal experiments and in vitro cellular and membrane research reports suggest that PMF stimulation can significantly reduce pain and accelerate the healing process. However, PMFs are still not widely used in clinical medicine. This research examines the effects of PMFs using an animal model that resembles human rheumatoid arthritis. Using serum protein electrophoresis (SPE) and joint edema evaluation, we were able to monitor disease progression and PMF therapeutic effectiveness. We have used these methods to correlate changes in an acute phase serum protein, alpha-2macroglobulin, with other indicators of rheumatoid arthritis in Lewis rats treated daily with PMF therapy. The results indicate that PMFs may be a promising non-invasive treatment for chronic inflammatory diseases like rheumatoid arthritis.

 

Fernandez, M. I.; Watson, P. J.; Rowbotham, D. J. (2007): Effect of pulsed magnetic field therapy on pain reported by human volunteers in a laboratory model of acute pain. In: British journal of anaesthesia, Jg. 99, H. 2, S. 266–269.

Abstract         BACKGROUND: Pulsed magnetic field therapy (PMFT) is a non-invasive, simple technique used extensively for the treatment of muscle pain. However, evidence to support its use from well-designed, clinical, or experimental studies is sparse. METHODS: We have utilized an acute pain model to perform a randomized, double-blinded, placebo-controlled, crossover-study on 10 male (18-40 yr) volunteers. Pain was elicited by infusion of hypertonic saline 5% into the brachioradialis muscle of the non-dominant arm on two occasions, at least 1 week apart. Subjects received active or sham PMFT for 30 min in a randomized order delivered by two identical, commercially available machines (PulsePack 6000, Quantum Techniks). The active machine delivered a M-wave magnetic pulse (1.25 Hz, 3 ms width, 600 Gauss); the sham device was deactivated and delivered no magnetic energy. Pain was assessed at 15-s intervals, and area under the visual analogue score (VAS) pain curve (AUCp) was calculated using the trapezoid method. RESULTS: There were no significant differences in mean VAS pain scores between the two machines at any time. In addition, there were no significant differences with respect to mean (sem) maximum pain score ÉAsham 60 (8), active 63 (9) mm; P = 0.66, 95% CI -18 to 12 mmÉU or AUCp ÉAsham 463 (50), active 499 (90); P = 0.64, 95% CI -201 to 129ÉU. CONCLUSIONS: We conclude that, using the electromagnetic characteristics of the machine in this study, the PMFT had no effect on pain in our experimental model. More work is required to provide an evidence base in support of the use of this technique for pain.

Category        5 III –descriptive Study

 

Fischer, G.; Pelka, R. B.; Barovic, J. (2005): Adjuvante Behandlung der Gonarthrose mit schwachen pulsierenden Magnetfeldern –Ergebnisse einer prospektiven, plazebokontrollierten vergleichenden Therapiestudie.; Adjuvant treatment of knee osteoarthritis with weak pulsing magnetic fields. Results of a placebo-controlled trial prospective clinical trial. In: Zeitschrift für Orthopädie und ihre Grenzgebiete, Jg. 143, H. 5, S. 544–550.

Abstract         PURPOSE: The aim of this study was the objective control of the therapeutic effect of weak pulsing magnetic fields (series of periodically repeating square pulses increasing according to an e-function, frequencies of 10, 20, 30, and 200-300 Hz) by means of a double-blind study on osteoarthritis of the knee. Measured parameters were the Knee Society score, pain sensation, blood count and cardiocirculatory values. METHODS: 36 placebo and 35 verum test persons (all with a knee gap smaller than 3 mm) were exposed daily for 16 minutes over 6 weeks to a low frequency magnetic field (flux densities increasing gradually from 3.4 up to 13.6 microT) encompassing the whole body. The last data collection was made 4 weeks after the end of treatment. RESULTS: Principally, the statistically ensured results exclusively favour the used magnetic field therapy; by far the greatest number of at least significant differences was found at the end of the whole treatment, lasting 6 weeks. In particular, it is striking that all 4 questioned pain scales showed at least significant improvements in favour of the verum collective; also the walking distance was increased. As another confirmed fact, even after 4 weeks without therapy the persistence of several functional and analgesic effects could be documented. CONCLUSIONS: Predominantly, on the one hand, pain relief in osteoarthritis patients was confirmed by a double-blind trial, on the other hand, increases in mobility could be proven. Furthermore, we describe mainly the modes of action of low frequency magnetic energy and 3 physical concepts that are seen as the connecting link between electromagnetic fields coupled into connective tissue and biochemical repair and growth processes in bones and cartilage. Proceeding from the results of this and preceding studies, one has to consider seriously whether this kind of magnetic field application should not be employed as cost-effective and side effect-free alternative or adjuvant form of therapy in the field of orthopaedic disorders.

Category        3 IIa – controlled Study

 

Galloway, N. T.; El-Galley, R. E.; Sand, P. K.; Appell, R. A.; Russell, H. W.; Carlin, S. J. (2000): Update on extracorporeal magnetic innervation (EXMI) therapy for stress urinary incontinence. In: Urology, Jg. 56, H. 6 Suppl 1, S. 82–86.

Abstract         Pulsed magnetic technology has been developed for pelvic floor muscle strengthening for the treatment of urinary incontinence. This report includes an update of the prospective multicenter study of extracorporeal magnetic innervation (ExMI) therapy for stress incontinence and a discussion of the possible mechanisms of action. Issues of patient selection for ExMI therapy will also be discussed. One hundred and eleven women with demonstrable stress urinary incontinence were studied. The mean age was 55 +/-13 years, and the mean duration of symptoms was 11 years. Ninety-seven completed ExMI therapy and analysis. Evaluation before treatment included bladder diaries, dynamic pad weight test, urodynamics, and a quality-of-life survey. For treatment the patients were seated fully clothed in a Neocontrol chair with a magnetic field therapy head in the seat. Treatment sessions were for 20 minutes, twice a week, for 6 weeks. After ExMI therapy, all of the measures were repeated at 8 weeks, including the dynamic pad weight testing and quality-of-life survey. At 6 months, further data were added, including repeat bladder diary, pad use, and quality-of-life survey. Forty-seven women completed 6 months of follow-up; of the 47, 13 patients were completely dry (28%) and 25 used no pad or less than 1 pad per day (53%). Pad use was reduced in 33 patients (70%). The median number of pads was reduced from 2.16 to 1 per day (Wilcoxon signed rank test, P <0.005). The frequency of leak episodes was reduced from 3.0 to 1.7 at 6 months (Wilcoxon signed rank test, P = 0.004). Detrusor instability was demonstrated in 10 before and 6 after ExMI (P <0.05) . ExMI offers an alternative approach for the treatment of urinary incontinence. ExMI therapy is effective for both stress and urge incontinence. The best results are achieved in those patients who use no more than 3 pads a day and have had no prior continence surgery.

Category        5 III – descriptive Study

 

Haddad, Jack B.; Obolensky, Alexis Guy; Shinnick, Phillip (2007): The biologic effects and the therapeutic mechanism of action of electric and electromagnetic field stimulation on bone and cartilage: new findings and a review of earlier work. In: Journal of alternative and complementary medicine (New York, N.Y.), Jg. 13, H. 5, S. 485–490.

Abstract         BACKGROUND: Muscle, ligament, bone, cartilage, blood, and adult stem-cell production all respond to electric and electromagnetic fields, and these biophysical field agents can be applied in therapeutic contexts. Postulated mechanisms at the cellular, subcellular, and molecular level are discussed. Electric and electromagnetic field stimulation enhance the repair of bone through the mediation of three areas at the cellular level: (1) the complex interplay of the physical environment; (2) growth factors; and (3) the signal transduction cascade. Studies of electric and electromagnetic fields suggest that an intermediary mechanism of action may be an increase in morphogenetic bone proteins, transforming growth factor-beta, and the insulin-like growth factor II, which results in an increase of the extracellular matrix of cartilage and bone. Investigations have begun to clarify how cells respond to biophysical stimuli by means of transmembrane signaling and gene expression for structural and signaling proteins. METHODS: Review of meta-analysis trials of electrical stimulation of all types. CONCLUSIONS: Further research in the form of methodologically sound, randomized, controlled studies are needed. Inter alia, resolutions are needed for the significant disparities between clinical targets, types of electrical stimulation, and clinical outcomes.

Category        1 Ia -Meta-Analysis

 

Holcomb, R. R.; Worthington, W. B.; McCullough, B. A.; McLean, M. J. (2000): Static magnetic field therapy for pain in the abdomen and genitals. In: Pediatric neurology, Jg. 23, H. 3, S. 261–264.

Abstract         Two adolescents with debilitating, medication-resistant, chronic pain of the low back and abdomen with intermittent pain of the genitalia were diagnosed with intervertebral disk disease at spinal cord levels that correlated with their signs. Both patients had undergone multiple evaluations by physicians of different specialties and both underwent appendectomy without relief of their pain. The history of the onset of pain was important in determining the affected levels. The pain of both individuals was mimicked and localized by percussion of the vertebral spines at the level of disk protrusion. This maneuver and careful review of the history were important in making the correct diagnosis in each case. In both patients, treatment with novel magnetic devices provided rapid relief that was sustained for more than 2 years. These cases highlight the need for careful evaluation and correct diagnosis of abdominal and genital pain in young patients to avoid costly and unnecessary medical intervention and the stigma of painful debility.

Category        6 IV – Expert Opinion

 

Huntley, A. (2006): A review of the evidence for efficacy of complementary and alternative medicines in MS. In: International MS journal / MS Forum, Jg. 13, H. 1, S. 5-12, 4.

Abstract         The role of complementary and alternative medicine for the management of MS symptoms lies in palliative care: this is borne out by the popularity of such therapies among people with MS. This article describes some of the major complementary and alternative therapies used to treat MS symptoms and whether their use is supported by evidence from randomized controlled trials. For the vast majority of complementary and alternative regimens researched, there are only one or two trials per therapy. Thus, it is difficult to recommend any specific modality. Several trials have investigated linoleic acid and its derivatives, magnetic field therapy and cannabis extracts. All three approaches appear to be of use in ameliorating MS symptoms but more research is needed. Other issues that should be considered by MS patients when taking a complementary or alternative therapy are discussed.

Category        1 Ia -Meta-Analysis

 

Huntley, A.; Ernst, E. (2000): Complementary and alternative therapies for treating multiple sclerosis symptoms: a systematic review. In: Complementary therapies in medicine, Jg. 8, H. 2, S. 97–105.

Abstract         Multiple sclerosis (MS) is a chronic disease of the central nervous system without a known cure. Thus the role of complementary and alternative therapies (CATs) for the management of symptoms lies in palliative care and this is borne out by the popularity of these treatments amongst MS sufferers.This review is aimed at determining whether this use is supported by evidence of effectiveness from rigorous clinical trials. Database literature searches were performed and papers were extracted in a pre-defined manner.Twelve randomized controlled trials were located that investigated a CAT for MS: nutritional therapy (4), massage (1), Feldenkrais bodywork (1), reflexology (1), magnetic field therapy (2), neural therapy (1) and psychological counselling (2).The evidence is not compelling for any of these therapies, with many trials suffering from significant methodological flaws. There is evidence to suggest some benefit of nutritional therapy for the physical symptoms of MS. Magnetic field therapy and neural therapy appear to have a short-term beneficial effect on the physical symptoms of MS. Massage/bodywork and psychological counselling seem to improve depression, anxiety and self-esteem. The effectiveness for other CATs is unproven at this time. In all the CATs examined further investigations are needed in the form of rigorous large-scale trials.

Category        1 Ia -Meta-Analysis

 

Klimczak, J.; Franek, A.; Blaszczak, E. (2000): Wczesne wyniki usprawniania leczniczego chorych po rekonstrukcji wiezadla krzyzowego przedniego.; Early results of patient rehabilitation after anterior cruciate ligament reconstruction. In: Polski merkuriusz lekarski, Jg. 9, H. 53, S. 760–763.

Abstract         In the Orthopedic Department of the Upper-Silesian Rehabilitation Center “Repty” in Ustron 54 patients have been rehabilitated after a plasty of the anterior cruciate ligament and transplantation of 1/3 middle part of the patellar ligament with two osseous blocks at each end. The rehabilitation was conducted according to the scheme worked out in our department. The results of the rehabilitation were assessed by the objective and subjective methods (for example the goniometric pendulum test, the modified Lysholm’s scale, the WAS questionnaire). The patients had been divided randomly into two comparative study groups that were subject to exactly the same rehabilitation scheme, but one of the group was additionally provided with the impulsive magnetic field therapy. A satisfactory improvement was observed in both groups of patients. There was no significant advantage of additional treatment with the impulsive magnetic field.

Category        5 III – descriptive Study

 

Lisinski, P.; Trojanowicz, M.; Stryla, W. (2005): Laseroterapia i magnetoterapia jako metody wspomagajace leczenie zespolu bolowego kregoslupa szyjnego.; Laser therapy and magnetic field therapy as auxiliary treatment for neck pain. In: Ortopedia, traumatologia, rehabilitacja, Jg. 7, H. 3, S. 302–305.

Abstract         Background. Neck pain has become a serious epidemiological and therapeutic problem. Among the most important reasons for this are sedentary lifestyles and low levels of physical activity. The goal of our study was to compare the effectiveness of low-energy laser radiation and low frequency magnetic field in the treatment of neck pain. Material and method. We examined 40 persons with neck pain, half of whom were treated by laser-therapy, and the rest by magnetic field therapy. Results. Laser therapy and magnetic field therapy were very effective in lowering pain intensity, the frequency of episodes, and the necessity for pharmacological co-treatment. Conclusions. Both methods appeared very effective. Because laser therapy acted faster, it should be recommended more often, particularly in acute cases.

Category        5 III – descriptive Study

 

Lunt, M. J. (1985): Theoretical model for investigating the magnetic and electric fields produced during pulsed magnetic field therapy for nonunion of the tibia. In: Medical & biological engineering & computing, Jg. 23, H. 4, S. 293–300.

 

Man, D.; Man, B.; Plosker, H. (1999): The influence of permanent magnetic field therapy on wound healing in suction lipectomy patients: a double-blind study. In: Plastic and reconstructive surgery, Jg. 104, H. 7, S. 2261-6; discussion 2267-8.

Abstract         The authors present their experience with the healing influence of permanent magnets on postoperative wounds. The responses of 20 patients who underwent suction lipectomy and postoperative negative magnetic field therapy were studied in a double-blind fashion. Magnets in the form of patches (10 patients) or sham magnet patches (10 patients) were placed over the operative region in each of the patients. Pain, edema, and discoloration (ecchymosis) were evaluated at 1, 2, 3, 4, 7, and 14 days postoperatively. Our results show that the treatment group had significant reductions in pain on postoperative days 1 through 7, in edema on days 1 through 4, and in discoloration on days 1 through 3 when compared with the control group. These results demonstrated that commercially available magnets have a positive influence on the postoperative healing process in suction lipectomy patients.

Category        5 III – descriptive Study

 

Markov, M. S. (2007): Magnetic field therapy: a review. In: Electromagnetic biology and medicine, Jg. 26, H. 1, S. 1–23.

Abstract         There is increasing interest in using permanent magnets for therapeutic purposes encouraged by basic science publications and clinical reports. Magnetotherapy provides a non invasive, safe, and easy method to directly treat the site of injury, the source of pain and inflammation, and other types of disease. The physiological bases for the use of magnetic fields for tissue repair as well as physical principles of dosimetry and application of various magnetic fields are subjects of this review. Analysis of the magnetic and electromagnetic stimulation is followed by a discussion of the advantage of magnetic field stimulation compared with electric current and electric field stimulation.

Category        1 Ia -Meta-Analysis

 

Mayr, E.; Wagner, S.; Ecker, M.; Rüter, A. (1999): Die Ultraschalltherapie bei Pseudarthrosen. 3 Fallbeschreibungen.; Ultrasound therapy for nonunions. Three case reports. In: Der Unfallchirurg, Jg. 102, H. 3, S. 191–196.

Abstract         Despite of the good results of operative treatment disorders of fracture healing are still a challenge for surgeons. In some cases all endeavours are frustrating and bone does not heal. Low intensity pulsed ultrasound (frequency: 1.5 MHz, pulsed by 1 KHz, signal burst width: 200 musec, intensity: 30 mW/cm2) offers the opportunity of an alternative treatment. In contrast to magnetic field therapy, electric stimulation or use of extracorporal shock waves this therapy is judged positively all over the literature. Within an own series of 76 cases at present time we can show a 86% healing rate under defined conditions. Within this paper we present three case reports, which clearly show the efficiency of low intensity pulsed ultrasound.

Category        6 IV – Expert Opinion

 

Morris, C. E.; Skalak, T. C. (2007): Chronic static magnetic field exposure alters microvessel enlargement resulting from surgical intervention. In: Journal of applied physiology, Jg. 103, H. 2, S. 629–636.

Abstract         Magnetic field therapy has recently become a widely used complementary/alternative medicine for the treatment of vascular, as well as other musculoskeletal pathologies, including soft tissue injuries. Recent studies in our laboratory and others have suggested that acute static magnetic field (SMF) exposure can have a modulatory influence on the microvasculature, acting to normalize vascular function; however, the effect of chronic SMF exposure has not been investigated. This study aimed to measure, for the first time, the adaptive microvascular response to a chronic 7-day continuous magnetic field exposure. Murine dorsal skinfold chambers were applied on day 0, and neodymium static magnets (or size and weight-matched shams) were affixed to the chambers at day 0, where they remained until day 7. Separate analysis of arteriolar and venular diameters revealed that chronic SMF application significantly abrogated the luminal diameter expansion observed in sham-treated networks. Magnet-treated venular diameters were significantly reduced at day 4 and day 7 (34.3 and 54.4%, respectively) compared with sham-treated vessels. Arteriolar diameters were also significantly reduced by magnet treatment at day 7 (50%), but not significantly at day 4 (31.6%), although the same trend was evident. Venular functional length density was also significantly reduced (60%) by chronic field application. These results suggest that chronic SMF exposure can alter the adaptive microvascular remodeling response to mechanical injury, thus supporting the further study of chronic application of SMFs for the treatment of vascular pathologies involving the dysregulation of microvascular structure.

Category        4 IIb – experimental Study

 

Mostert, S.; Kesselring, J. (2005): Effect of pulsed magnetic field therapy on the level of fatigue in patients with multiple sclerosis–a randomized controlled trial. In: Multiple sclerosis, Jg. 11, H. 3, S. 302–305.

Abstract         Twenty-five multiple sclerosis patients, taking part in a rehabilitation program, were randomly assigned to treatment with pulsed magnetic field therapy (PMFT) or to sham therapy in order to study the additional effect of PMFT as part of a multimodal neurological rehabilitation program on fatigue. Patients demographic and disease specific characteristics were recorded. Level of fatigue was measured by fatigue severity scale (FSS) at entrance and discharge and with a visual analog scale (VAS) immediate before and after a single treatment session. The ‘Magnetic Cell Regeneration’ system by Santerra was used for PMFT. A single treatment lasted 16 minutes twice daily over 3-4 weeks and consisted of relaxed lying on a PMF mattress. Sham intervention was conducted in an identical manner with the PMF-device off. Patients and statistics were blinded. Level of fatigue measured by FSS was high at entrance in both treatment group (TG) and control group (CG) (5.6 versus 5.5). Over time of rehabilitation fatigue was reduced by 18% in TG and 7% in CG which was statistically not significant. There was a statistically significant immediate effect of the single treatment session which 18% reduction of fatigue measured by VAS in TG versus 11% in CG. Because of a high ‘placebo effect’ of simple bed rest, a only small and short lasting additional effect of PMFT and high costs of a PMF-device, we cannot recommend PMFT as an additional feature of a multimodal neurological rehabilitation program in order to reduce fatigue level of MS-patients.

Category        2 Ib -RCT

 

Nicolakis, P.; Kollmitzer, J.; Crevenna, R.; Bittner, C.; Erdogmus, C. B.; Nicolakis, J. (2002): Pulsed magnetic field therapy for osteoarthritis of the knee–a double-blind sham-controlled trial. In: Wiener klinische Wochenschrift, Jg. 114, H. 15-16, S. 678–684.

Abstract         BACKGROUND AND METHODS: Pulsed magnetic field therapy is frequently used to treat the symptoms of osteoarthritis, although its efficacy has not been proven. We conducted a randomized, double-blind comparison of pulsed magnetic field and sham therapy in patients with symptomatic osteoarthritis of the knee. Patients were assigned to receive 84 sessions, each with a duration of 30 minutes, of either pulsed magnetic field or sham treatment. Patients administered the treatment on their own at home, twice a day for six weeks. RESULTS: According to a sample size estimation, 36 consecutive patients were enrolled. 34 patients completed the study, two of whom had to be excluded from the statistical analysis, as they had not applied the PMF sufficiently. Thus, 15 verum and 17 sham-treated patients were enrolled in the statistical analysis. After six weeks of treatment the WOMAC Osteoarthritis Index was reduced in the pulsed magnetic field-group from 84.1 (+/-45.1) to 49.7 (+/-31.6), and from 73.7 (+/-43.3) to 66.9 (+/52.9) in the sham-treated group (p = 0.03). The following secondary parameters improved in the pulsed magnetic field group more than they did in the sham group: gait speed at fast walking ÉA+6.0 meters per minute (1.6 to 10.4) vs. -3.2 (-8.5 to 2.2)ÉU, stride length at fast walking ÉA+6.9 cm (0.2 to 13.7) vs. -2.9 (-8.8 to 2.9)ÉU, and acceleration time in the isokinetic dynamometry strength tests ÉA-7. 0% (-15.2 to 1.3) vs. 10.1% (-0.3 to 20.6)ÉU. CONCLUSION: In patients with symptomatic osteoarthritis of the knee, PMF treatment can reduce impairment in activities of daily life and improve knee function.

Category        2 Ib -RCT

 

Nyland, J.; Nolan, M. F. (2004): Therapeutic modality: rehabilitation of the injured athlete. In: Clinics in sports medicine, Jg. 23, H. 2, S. 299-313, vii.

Abstract         Traditional therapeutic modalities include cryotherapy, sonotherapy, pulsed electrical stimulation, transcutaneous electrical nerve stimulation, high-volt pulsed current, and iotopheresis. Alternative modalities include acupuncture, magnetic field therapy, biofeedback, and massage. All therapeutic modalities should be considered adjuncts to progressive functional exercise. Controlled studies rarely reach consensus regarding the efficacy of therapeutic modalities,so their use should be individualized to the patient.

Category        1 Ia -Meta-Analysis

 

O’Connor, B. T. (1984): Pulsed magnetic field therapy for tibial non-union. In: Lancet, Jg. 2, H. 8395, S. 171–172.

Category        6 IV –Expert opinion

 

Oepen, I. (1992): Kritische Bewertung unkonventioneller diagnostischer und therapeutischer Methoden in der Zahnheilkunde.; A critical evaluation of unconventional diagnostic and therapeutic methods in dentistry. In: Fortschritte der Kieferorthopädie, Jg. 53, H. 4, S. 239–246.

Abstract         Unconventional, i.e. disputed medical methods are offered to many patients. However, the propagated effects of such methods could not be confirmed by controlled studies. So, neither any risk taken by the use of these methods, can be justified nor are any costs for treatment vindicated. In future, and contrary to the prevailing attitude, these facts should become a matter of more serious concern, the more so, as with harmonization of EG legal regulations, adaptation to those European countries in which unconventional medical methods are evaluated more critical than in Germany, is to be expected. The following methods are discussed in detail: regulation thermography, Lüscher’s test, homeopathy, homeopathy autoblood therapy, nosoden therapy, acupuncture, magnetic field therapy, ozone therapy, Mora therapy, lymph drainage, management of symbiosis, and anthroposophical medicine.

Category        6 IV –Expert opinion

 

Orlov, L. L.; Makoeva, L. D.; Pochechueva, G. A.; Arzhanenko, O. M.; Belinskaia, T. F. (1996): “Begushchee” impul’snoe magnitnoe pole v lechenii stenokardii.; “Running” pulse magnetic field in treating stenocardia. In: Biofizika, Jg. 41, H. 4, S. 949–952.

Abstract         The influence of “running” impulse magnetic field, antianginal drugs and their combination on physical load tolerability, hemodynamics and functional state of hormonal system in patients with stable angina pectoris was studied. “Running” impulse magnetic field therapy produced marked antianginal effect in patients with I-II class angina and it was effective in combination with antianginal drugs in patients of III class angina. The reduction of attack frequency and significant physical load tolerability improvement was determined. The correcting influence of “running” impulse magnetic field on hypophysis-thyroid system hormones (TTH, T3, T4) was revealed, that correlates with physical load tolerability and myocardial contractility improvement. As monotherapy, the “running” impulse magnetic field can be administered to the patients with stable angina of I-II class and in combination with antianginal drugs-to the patients with severe angina.

Category        5 III –descriptive Study

 

Park, W. H.; Soh, K. S.; Lee, B. C.; Pyo, M. Y. (2008): 4 Hz magnetic field decreases oxidative stress in mouse brain: a chemiluminescence study. In: Electromagnetic biology and medicine, Jg. 27, H. 2, S. 165–172.

Abstract         We investigated the effects of delta and theta brain wave frequency magnetic fields (3, 4, and 5) on mouse brain by detecting photonic oxidative stress makers; spontaneous photon emission (SPE) and lucigenin and tert-butyl hydroperoxide (TBHP) induced chemiluminescences (CL). For this purpose, Balb/C mice were exposed to 3, 4, and 5 Hz magnetic fields (MF) at 0.7 mT for 3 h, respectively. After that we monitored SPE and lucigenin and TBHP-induced CL of the homogenates of mice brains. There was a significant decrease in SPE in the 4 Hz MF-exposed group. Lucigenin-induced CL was also significantly decreased only in the 4 Hz MF-exposed group. TBHP-induced CL was also distinctively decreased by all frequencies, 3, 4, and 5 Hz MF exposures. These results showed that oxidative stress in a mouse brain was decreased by 4 Hz MF. We suggest that the application of 4 Hz MF will contribute to magnetic field therapy.

 

Pelka, R. B.; Jaenicke, C.; Gruenwald, J. (2001): Impulse magnetic-field therapy for insomnia: a double-blind, placebo-controlled study. In: Advances in therapy, Jg. 18, H. 4, S. 174–180.

Abstract         This 4-week double-blind, placebo-controlled study assessed the efficacy of impulse magnetic-field therapy for insomnia. One hundred one patients were randomly assigned to either active treatment (n = 50) or placebo (n = 51) and allocated to one of three diagnostic groups: (1) sleep latency; (2) interrupted sleep; or (3) nightmares. Efficacy endpoints were intensity of sleep latency, frequency of interruptions, sleepiness after rising, daytime sleepiness, difficulty with concentration, and daytime headaches. In the active-treatment group, the values of all criteria were significantly lower at study end (P < .00001). The placebo group also showed significant symptomatic improvement (P < .05), but the differences between groups were highly significant (P < .00001). Seventy percent (n = 34) of the patients given active treatment experienced substantial or even complete relief of their complaints; 24% (n = 12) reported clear improvement; 6% (n = 3) noted a slight improvement. Only one placebo patient (2%) had very clear relief; 49% (n = 23) reported slight or clear improvement; and 49% (n = 23) saw no change in their symptoms. No adverse effects of treatment were reported.

Category        2 Ib -RCT

 

Pelka, R. B.; Jaenicke, C.; Gruenwald, J. (2001): Impulse magnetic-field therapy for migraine and other headaches: a double-blind, placebo-controlled study. In: Advances in therapy, Jg. 18, H. 3, S. 101–109.

Abstract         This double-blind, placebo-controlled study assessed the efficacy of 4 weeks of impulse magnetic-field therapy (16 Hz, 5 microTs), delivered through a small device, for different types of headache and migraine. Eighty-two patients were randomly assigned to receive either active treatment or placebo (n = 41 each) and were characterized according to one of seven diagnoses (migraine, migraine combined with tension, tension, cluster, weather-related, posttraumatic, or other). Efficacy was assessed in terms of duration, severity, and frequency of migraine and headache attacks, as well as ability to concentrate. Data for 77 patients were analyzed. In the active-treatment group, all assessed criteria were significantly improved at the end of the study (P < .0001 vs baseline and placebo). Seventy-six percent of active-treatment patients experienced clear or very clear relief of their complaints. Only 1 placebo-patient (2.5%) felt some relief; 8% noted slight and 2% reported significant worsening of symptoms. No side effects were noted.

Category        2 Ib -RCT

 

Pelka, R. B.; Jaenicke, C.; Gruenwald, J. (2002): Impulse magnetic-field therapy for erectile dysfunction: a double-blind, placebo-controlled study. In: Advances in therapy, Jg. 19, H. 1, S. 53–60.

Abstract         This double-blind, placebo-controlled study assessed the efficacy of 3 weeks of impulse magnetic-field therapy for erectile dysfunction (ED). Twenty volunteers who suffered from ED or orgasmic disturbances were randomly assigned to either active treatment or placebo (n = 10 each). Efficacy was assessed in terms of intensity and duration of erection, general well-being, sexual activity, and warm sensation in the genital area. In the active-treatment group, all efficacy endpoints were significantly improved at study end (P < or = .01), with 80% reporting increases in intensity and duration of erection, frequency of genital warmth, and general well-being. The remaining 20%, who experienced minor improvements, were found to have an influenza-like infection after the study that may have influenced their results. Only 30% of the placebo group noted some improvement in their sexual activity; 70% had no change. No side effects were reported.

Category        2 Ib -RCT

 

Pieber, K.; Schuhfried, O.; Fialka-Moser, V. (2007): Magnetfeldtherapie–Ergebnisse hinsichtlich evidence based medicine. ; Pulsed electromagnetic fields (PEMF)–results in evidence based medicine. In: Wiener medizinische Wochenschrift, Jg. 157, H. 1-2, S. 34–36.

Abstract         Therapy with electromagnetic fields has a very old tradition in medicine. The indications are widespread, whereas little is known about the effects. Controlled randomizied studies with positive results for pulsed electromagnetic fields (PEMF) are available for osteotomies, the healing of skin wounds, and osteoarthritis. Comparison of the studies is difficult because of the different doses applied and intervals of therapy. Therefore recommendations regarding an optimal dosis and interval are, depending on the disease, quite variable.

 

Q #1 :Quittan, M.; Schuhfried, O.; Wiesinger, G. F.; Fialka-Moser, V. (2000): Klinische Wirksamkeiten der Magnetfeldtherapie–eine Literaturübersicht.; Clinical effectiveness of magnetic field therapy–a review of the literature. In: Acta medica Austriaca, Jg. 27, H. 3, S. 61–68.

 

Abstract         To verify the efficacy of electromagnetic fields on various diseases we conducted a computer-assisted search of the pertinent literature. The search was performed with the aid of the Medline and Embase database (19661998) and reference lists. Clinical trials with at least one control group were selected. The selection criteria were met by 31 clinical studies. 20 trials were designed double-blind, randomised and placebo-controlled. The studies were categorised by indications. Electromagnetic fields were applied to promote bone-healing, to treat osteoarthritis and inflammatory diseases of the musculoskeletal system, to alleviate pain, to enhance healing of ulcers and to reduce spasticity. The action on bone healing and pain alleviation of electromagnetic fields was confirmed in most of the trials. In the treatment of other disorders the results are contradictory. Application times varied between 15 minutes and 24 hours per day for three weeks up to eighteen months. There seems to be a relationship between longer daily application time and positive effects particular in bone-healing. Patients were treated with electromagnetic fields of 2 to 100 G (0.2 mT to 10 mT) with a frequency between 12 and 100 Hz. Optimal dosimetry for therapy with electromagnetic fields is yet not established.

Category        1 Ia -Meta-Analysis

 

Railton, R.; Newman, P. (1983): Magnetic field therapy-does it affect soft tissue? *. In: The Journal of orthopaedic and sports physical therapy, Jg. 4, H. 4, S. 241–246.

Abstract         Claims that magnetic field therapy improves peripheral circulation and tissue oxygenation have been tested on normal volunteers. Transcutaneous oxygen tension measurements were made and skin temperatures measured in a double blind trial. Using recommended magnetic field configurations, no significant effects attributable to the magnetic field therapy could be demonstrated. J Orthop Sports Phy Ther 1983;4(4):241-246.

Category        2 Ib -RCT

 

Rooney, B.; Fiocco, G.; Hughes, P.; Halter, S. (2001): Provider attitudes and use of alternative medicine in a midwestern medical practice in 2001. In: WMJ, Jg. 100, H. 7, S. 27–31.

Abstract         OBJECTIVE: To determine the current level of use, referral and desire for service of different complementary and alternative (CAM) therapies among GundersenLutheranMedicalCenter providers. METHODS: A survey was conducted in January of 2001 of all medical and associate staff. RESULTS: The response rate was 79%; 55% reported using 1 or more of 18 therapies for themselves. Over 25% of providers used nutritional supplements, herbal medicines, or hydrotherapy with a patient. Over half of providers had referred a patient for biofeedback or chiropractic care. Over half of providers would like to offer acupuncture, biofeedback, chiropractic care, hydrotherapy, nutritional supplements, or massage to patients in the future. Associate staff, female staff, primary care providers, and those who had personally used CAM therapies were more likely to have used, referred, or wish to offer more therapies in the future. There was little support for aromatherapy, magnetic field therapy, naturopathic medicine, or ethnic healing methods. CONCLUSIONS: Use of and desire for complementary therapies at Gundersen Lutheran was higher than expected by the Integrative Medicine Oversight Committee. Health care organizations should consider having a process in place to manage the increasing demands for complementary and alternative therapies.

Category        6 IV –Expert opinion

 

Schuh, A.; Jezussek, D.; Fabijani, R.; Hönle, W. (2007): Bleiben Sie kritisch bei der Wahl Ihrer Therapie!; Conservative Therapy of Knee Osteoarthritis. In: MMW Fortschritte der Medizin, Jg. 149, H. 25-26, S. 31–32.

Abstract         Many highly effective measures as well as orthopaedic aids are available for the conservative therapy of knee osteoarthritis. When appropriately implemented for the stage of the disease,they can clearly alleviate the patient’s symptoms. However, physiotherapy, physical therapy, balneotherapy and the usual conservative treatment options are not capable of stopping the progression of knee osteoarthritis. Other conservative therapeutic options such as magnetic field therapy, pulse signal therapy, radiotherapy, radiosynoviorthesis, acupuncture and drug therapies improve symptoms to different extents. For this reason, their application should always be critically evaluated.

Category        6 IV –Expert opinion

 

Strauch, B.; Patel, M. K.; Rosen, D. J.; Mahadevia, S.; Brindzei, N.; Pilla, A. A. (2006): Pulsed magnetic field therapy increases tensile strength in a rat Achilles’ tendon repair model. In: The Journal of hand surgery, Jg. 31, H. 7, S. 1131–1135.

Abstract         PURPOSE: To examine the effect of pulsing electromagnetic fields on the biomechanic strength of rat Achilles’ tendons at 3 weeks after transection and repair. METHODS: This noninvasive modality was tested in a prospective, randomized, double-blinded, placebo-controlled study to evaluate the effect of a specific noninvasive radiofrequency pulsed electromagnetic field signal on tendon tensile strength at 21 days post transection in a rat model. RESULTS: In the animals receiving PMF exposure, an increase in tensile strength of up to 69% was noted at the repair site of the rat Achilles’ tendon at 3 weeks after transection and repair compared with nonstimulated control animals. CONCLUSIONS: The application of electromagnetic fields, configured to enhance Ca(2+) binding in the growth factor cascades involved in tissue healing, achieved a marked increase of tensile strength at the repair site in this animal model. If similar effects occur in humans, rehabilitation could begin earlier and the risk of developing adhesions or rupturing the tendon in the early postoperative period could be reduced.

 

Sun, J. L.; Fan, J. Z.; Song, G. Z.; Tan, X. M.; Peng, N. (2007): Infrared radiation and magnetic field therapy ameliorates cartilage damage in rabbits with knee osteoarthritis. In: Nan fang yi ke da xue xue bao, Jg. 27, H. 12, S. 1851–1855.

Abstract         OBJECTIVE: To evaluate the effect of infrared radiation and magnetic field therapy on cartilage damage in rabbits with knee osteoarthritis. METHODS: Knee osteoarthritis was induced in 24 adult New Zealand rabbits by prolonged fixation of the knee joint in extension for 6 weeks. The rabbits were subsequently randomized into control group (without treatment), infrared therapy group, magnetic field therapy group and the combined infrared and magnetic field therapy group. At the end of the first, second and third weeks of the therapy, respectively, 2 rabbits from each group were sacrificed to observe the general changes and histopathology of the condylar cartilage of the femur, and the findings were assessed using Mankin scores. RESULTS: Compared with other groups, the rabbits in the combined therapy group showed significantly milder cartilage damage (including injury of the cartilage surface and chondrocyte’s proliferation and disarrangement) with significantly lower Mankin scores (P<0.05). No significant differences were found in the findings between the two groups with exclusive infrared or magnetic field therapy (P>0.1). CONCLUSION: Combined infrared and magnetic field therapy can effectively alleviate cartilage destruction, shortens the disease course and enhance the therapeutic effects in rabbits with knee osteoarthritis.

 

Suntsov, V. V. (1991): Lechenie ostrogo diffuznogo naruzhnogo otita s pomoshch’iu nizkochastotnogo magnitnogo polia.; Treatment of acute diffuse otitis externa by low-frequency magnetic field. In: Vestnik otorinolaringologii, H. 6, S. 35–38.

Abstract         Patients with acute diffuse external otitis were treated using an alternating and pulsatile low-frequency magnetic field synchronized with the pulse wave propagation across the pathological focus. It was shown that the magnetic exposure should be 30-40 min longer because the beneficial effect of the magnetic field develops as a function of time and because there should be a feedback between the acting magnetic field and hydrostatic pressure in focal capillaries which varies during inflammation. This therapeutic method was applied to 27 patients. The mean time on this method was 4 days shorter when compared to that on UHF and SHF therapy or 3 days shorter when compared to that on continuous magnetic field therapy, the difference being statistically significant.

Category        5 III – descriptive Study

 

Wajswelner, H. (1996): Management of rowers with rib stress fractures. In: Aust J Physiother, Jg. 42, H. 2, S. 157–161.

Abstract         Stress fractures of the ribs in rowers occur mostly along the anterior axillary line, but also anteriorly and posteriorly. Management has previously consisted of rest, but symptoms can recur on return to training. Earlier return to rowing can be achieved with management that includes ice and TENS for pain relief, pulsed magnetic field therapy and passive mobilisation of the thoracic spine and costovertebral joints. Aerobic fitness is maintained with stationary cycling. Rowing is progressively introduced according to symptoms and strapping is used to support the ribs during training. Posture and technique is reviewed with the coach to eliminate unusual movements of the shoulder girdle.

Category        5 III – descriptive Study

 

Weiler, E. W.; Brill, K. (2005): Pulsed magnetic-field therapy: a new concept to treat tinnitus. In: The international tinnitus journal, Jg. 11, H. 1, S. 58–62.

Abstract         Both clinical and neurophysiological data suggest that chronic tinnitus is characterized by focal brain activation. In the study reported here, pulsed magnetic-field therapy induced a highly significant increase of average total power for the delta, theta, and alpha frequency bands, predominantly within the frontal regions of the brain. We conclude that pulsed magnetic-field therapy induces changes of the electroencephalography pattern that correlated with a decrease in tinnitus symptoms.

Category        6 IV –Expert opinion

 

Weintraub, M. I.; Cole, S. P. (2004): Pulsed magnetic field therapy in refractory neuropathic pain secondary to peripheral neuropathy: electrodiagnostic parameters–pilot study. In: Neurorehabilitation and neural repair, Jg. 18, H. 1, S. 42–46.

Abstract         CONTEXT: Neuropathic pain (NP) from peripheral neuropathy (PN) arises from ectopic firing of unmyelinated C-fibers with accumulation of sodium and calcium channels. Because pulsed electromagnetic fields (PEMF) safely induce extremely low frequency (ELF) quasirectangular currents that can depolarize, repolarize, and hyperpolarize neurons, it was hypothesized that directing this energy into the sole of one foot could potentially modulate neuropathic pain. OBJECTIVE: To determine if 9 consecutive 1-h treatments in physician’s office (excluding weekends) of a pulsed signal therapy can reduce NP scores in refractory feet with PN. DESIGN/SETTING/PATIENTS: 24 consecutive patients with refractory and symptomatic PN from diabetes, chronic inflammatory demyelinating polyneuropathy (CIDP), pernicious anemia, mercury poisoning, paraneoplastic syndrome, tarsal tunnel, and idiopathic sensory neuropathy were enrolled in this nonplacebo pilot study. The most symptomatic foot received therapy. Primary endpoints were comparison of VAS scores at the end of 9 days and the end of 30 days follow-up compared to baseline pain scores. Additionally, Patients’ Global Impression of Change (PGIC) questionnaire was tabulated describing response to treatment. Subgroup analysis of nerve conduction scores, quantified sensory testing (QST), and serial examination changes were also tabulated. Subgroup classification of pain (Serlin) was utilized to determine if there were disproportionate responses. INTERVENTION: Noninvasive pulsed signal therapy generates a unidirectional quasirectangular waveform with strength about 20 gauss and a frequency about 30 Hz into the soles of the feet for 9 consecutive 1-h treatments (excluding weekends). The most symptomatic foot of each patient was treated. RESULTS: All 24 feet completed 9 days of treatment. 15/24 completed follow-up (62%) with mean pain scores decreasing 21% from baseline to end of treatment (P=0.19) but with 49% reduction of pain scores from baseline to end of follow-up (P<0.01). Of this group, self-reported PGIC was improved 67% (n=10) and no change was 33% (n=5). An intent-to-treat analysis based on all 24 feet demonstrated a 19% reduction in pain scores from baseline to end of treatment (P=0.10) and a 37% decrease from baseline to end of follow-up (P<0.01). Subgroup analysis revealed 5 patients with mild pain with nonsignificant reduction at end of follow-up. Of the 19 feet with moderate to severe pain, there was a 28% reduction from baseline to end of treatment (P<0.05) and a 39% decrease from baseline to end of follow-up (P<0.01). Benefit was better in those patients with axonal changes and advanced CPT baseline scores. The clinical examination did not change. There were no adverse events or safety issues. CONCLUSIONS: These pilot data demonstrate that directing PEMF to refractory feet can provide unexpected shortterm analgesic effects in more than 50% of individuals. The role of placebo is not known and was not tested. The precise mechanism is unclear yet suggests that severe and advanced cases are more magnetically sensitive. Future studies are needed with randomized placebo-controlled design and longer treatment periods.

Category        5 III – descriptive Study

 

Weintraub, M. I.; Wolfe, G. I.; Barohn, R. A.; Cole, S. P.; Parry, G. J.; Hayat, G. et al. (2003): Static magnetic field therapy for symptomatic diabetic neuropathy: a randomized, double-blind, placebo-controlled trial. In: Archives of physical medicine and rehabilitation, Jg. 84, H. 5, S. 736–746.

Abstract         OBJECTIVE: To determine if constant wearing of multipolar, static magnetic (450G) shoe insoles can reduce neuropathic pain and quality of life (QOL) scores in symptomatic diabetic peripheral neuropathy (DPN). DESIGN: Randomized, placebo-control, parallel study. SETTING: Forty-eight centers in 27 states. PARTICIPANTS: Three hundred seventy-five subjects with DPN stage II or III were randomly assigned to wear constantly magnetized insoles for 4 months; the placebo group wore similar, unmagnetized device. INTERVENTION: Nerve conduction and/or quantified sensory testing were performed serially. MAIN OUTCOME MEASURES: Daily visual analog scale scores for numbness or tingling and burning and QOL issues were tabulated over 4 months. Secondary measures included nerve conduction changes, role of placebo, and safety issues. Analysis of variance (ANOVA), analysis of covariance (ANCOVA), and chi-square analysis were performed. RESULTS: There were statistically significant reductions during the third and fourth months in burning (mean change for magnet treatment, -12%; for sham, -3%; P<.05, ANCOVA), numbness and tingling (magnet, -10%; sham, +1%; P<.05, ANCOVA), and exercise-induced foot pain (magnet, -12%; sham, -4%; P<.05, ANCOVA). For a subset of patients with baseline severe pain, statistically significant reductions occurred from baseline through the fourth month in numbness and tingling (magnet, -32%; sham, -14%; P<.01, ANOVA) and foot pain (magnet, -41%; sham, -21%; P<.01, ANOVA). CONCLUSIONS: Static magnetic fields can penetrate up to 20mm and appear to target the ectopic firing nociceptors in the epidermis and dermis. Analgesic benefits were achieved over time.

Category        2 Ib -RCT