Aetna considers high-frequency pulsed electromagnetic stimulation experimental and investigational for all indications, including the treatment of wounds, soft tissue injuries, mechanical neck disorders, osteoarthritis, subacromial impingement syndrome, or acute postoperative pain and edema because its effectiveness has not been established.

See also CPB 680 - Electrical Stimulation for Chronic Ulcers.

Various types of electrical stimulation have been examined for soft tissue injuries and wound healing.  These include direct electrical stimulation using high voltage pulsed currents or high voltage galvanic currents in which the electrodes are placed directly on the wound site, low voltage pulsed electromagnetic fields, and high frequency pulsed electromagnetic fields, which include Diapulse (Diapulse Corporation of America, Great Neck, NY).  Diapulse has been used in the management of chronic wounds, soft tissues injuries, and other indications including migraine, tinnitus, acute head injuries, and pelvic inflammatory disease.  Although there are case studies (Duma-Drzewinska and Buczynski, 1978; Itoh, et al., 1991; Comorosan, et al., 1993; Tung, et al., 1995) as well as small randomized controlled trials (Goldin, et al., 1981; Salzberg, et al,, 1995; and Kenkre, et al., 1996) that reported beneficial effects of Diapulse in treating refractory wounds, these studies had many drawbacks.   Another electromagnetic device for the treatment of refractory wounds and soft tissue injuries is SofPulse.  However, there is a lack of published data on its effectiveness for these indications.

Goldin, et al. (1981) focused on donor site skin graft healing reported positive results, but it is unclear how the positive outcome (90% healing) was selected, and whether the results were statistically different at other degrees of healing.  The statistical analysis involved adding the scores together from three different scales.  The validity of this type of analysis is very questionable.  Furthermore, healing of donor skin graft sites is perhaps physiologically different than the more common situation of pressure ulcer healing, and it is not clear if the results can be extrapolated from one clinical situation to another.

Salzberg, et al. (1995) examined if non-thermal pulsed electromagnetic energy treatment increases the healing rate of pressure ulcers in patients with spinal cord injuries (n = 30).  Subjects consisted of 30 male spinal cord-injured (SCI) patients, 20 with Stage II and 10 with Stage III pressure ulcers.  Subjects were given non-thermal pulsed high-frequency electromagnetic energy treatment for 30 minutes twice-daily for 12 weeks or until healed.  The percentage of pressure ulcers healed was measured at one week.  Of the 20 patients with Stage II pressure ulcers, the active group had a significantly increased rate of healing with a greater percentage of the ulcer healed at one week than the control group.  After controlling for the baseline status of the pressure ulcer, active treatment was independently associated with a significantly shorter median time to complete healing of the ulcer.  Stage III pressure ulcers healed faster in the treatment group but the sample size was limited.  The authors concluded that the results of this study suggested that non-thermal pulsed electromagnetic energy treatment is safe and accelerates wound healing in SCI men with Stage II pressure ulcers.

Diapulse has also been used for the treatment of acute post-operative pain and edema.  This application is more difficult to evaluate due to the lack of objective outcome measures.  However, randomized controlled trials are still considered critical.  Both Wilson (1974) and Barclay (1983) reported positive results in randomized trials looking at ankle and hand injuries, respectively, but the statistical analysis was seriously flawed compromising any evaluation of the results.  Pennington, et al. (1993) reported the use of Diapulse to reduce swelling in association with ankle sprains in an effort to reduce lost training days in the military.  Although this randomized trial showed a 4.7% decrease in ankle volume (compared to 0.95% decrease in the control group), the clinical significance of this finding is unknown.  For example, it is not known if the use of Diapulse actually reduced the morbidity of ankle sprains in terms of lost training days.  In addition, the specific statistical test used to evaluate the results is not given.  Bentall and Eckstein (1975) studied the use of Diapulse to reduce post-operative ecchymoses and edema in patients undergoing orchidopexy.  This randomized double blind study showed a significant improvement in scrotal wound color changes at 6 and 8 days post surgery.  The clinical significance of these findings is unknown.  Finally, there have been two studies on the use of Diapulse after oral surgery (Aronofsky, 1971; Rhodes, 1981).  However, both represented case series studies, so the true contribution of Diapulse cannot be determined.

In 1995, the Health Care Financing Administration (HCFA) commissioned the Emergency Care Research Institute (ECRI), an independent, nonprofit health services research agency, to conduct an assessment of electrical stimulation, which included pulsed electromagnetic field stimulation (e.g., Diapulse and SofPulse devices) for chronic wound healing.  In November, 1996, ECRI’s Technology Advisory Committee reported its final conclusion stating that electrostimulation does not appear to be markedly superior or inferior to conventional or alternative therapies for chronic wound healing (HCFA, 1996).  Based on this assessment on published trials, HCFA (1997) issued a national coverage policy stating “there is insufficient evidence to determine any clinically significant differences in healing rates.  Therefore, electrical stimulation cannot be covered by Medicare because its effectiveness has not been adequately demonstrated”.

Flemming and Cullum (2003) evaluated the evidence supporting the use of Diapulse electromagnetic therapy for treating pressure sores and reached the following conclusions: "The results suggest no evidence of a benefit in using electromagnetic therapy to treat pressure sores. However the possibility of a beneficial or harmful effect cannot be ruled out due to the fact there were only two trials with methodological limitations and small numbers of patients."

In December 2003, the Centers for Medicare & Medicaid Services (CMS) decided to reverse its initial (July 2002) non-coverage of EMS for the treatment of chronic wounds.  Currently, CMS covers the use of ES and electromagnetic stimulation for chronic Stage III and Stage IV pressure ulcers, arterial ulcers, diabetic ulcers and venous stasis ulcers.  Chronic ulcers are defined as those that have not healed despite 30 days of treatment with standard wound therapy.  In reversing its position, CMS appeared to have classified EMS to be similar to ES and cited the AHCPR Clinical Practice Guideline for the treatment of pressure ulcers, which recommends a course of treatment with ES for Stage III and Stage IV pressure ulcers that are refractory to conventional therapy (Bergstrom, et al., 1994).  It is interesting to note that the AHCPR recommendation was based on the findings of four studies, none of which used EMS for the treatment of pressure ulcers.  CMS also discussed the ECRI report (1996) that there is evidence that pulsed electromagnetic energy (PEE) stimulation improves the normalized healing rates for Stage II decubitus ulcers.  However, the ECRI report also stated there is insufficient evidence to determine whether PEE stimulation improves the normalized healing rates of Stage III or Stage IV decubitus ulcers.  Furthermore, there is no evidence that PEE stimulation improves the healing rates of chronic venous or diabetic ulcers.

Of note, the ECRI assessment also concluded that there is evidence that pulse electromagnetic field (PEMF) stimulation improves the normalized healing rates of venous ulcers.  However, this improvement appears to be small and may not be clinically useful.  Furthermore, the report stated that there is no evidence that PEMF stimulation improves the healing rate of chronic decubitus or diabetic ulcers.

The BlueCross BlueShield Association Medical Advisory Panel concluded that electromagnetic therapy for chronic skin wounds does not meet the TEC criteria (BCBSA, 2005).  This is in agreement with the assessment on pulsed signal therapy (PST) for musculoskeletal conditions conducted by the British Columbia Office of Health Technology Assessment (Sibley, et al., 2001).  The assessment focused on PST, which is a type of PEMF.  The BCOHTA assessment also summarized the literature on PEMF generally, and concluded that "there are no published controlled, clinical trials showing that PST provides a clinical advantage versus placebo or other PEME devices".

Furthermore, in a systematic review on wound care management, Cullum, et al. (2001) concluded that there is generally insufficient reliable evidence to draw conclusions about the contribution of laser therapy, therapeutic ultrasound, electro-therapy and electromagnetic therapy to chronic wound healing.  Flemming and Cullum (2001) also concluded that there is currently no reliable evidence of benefit of electromagnetic therapy in the healing of venous leg ulcers.

In a Cochrane review, Hulme, et al. (2002) examined the effectiveness of pulsed electric stimulation in treating patients with osteoarthritis (pulsed electric stimulation has been demonstrated to stimulate cartilage growth on the cellular level).  These investigators concluded that current evidence suggests that electrical stimulation therapy may provide significant improvements for knee osteoarthritis, but further studies are needed to confirm whether the statistically significant findings shown in these studies result in important health benefits.

In a Cochrane review, Kroeling, et al. (2005) stated that no definitive statements on electrotherapy for mechanical neck disorders can be made.  The current evidence on galvanic current (direct or pulsed), iontophoresis, transcutaneous electrical nerve stimulation, electronic muscle stimulation, low- or high-frequency pulsed electromagnetic stimulation, and permanent magnets is lacking, limited, or conflicting.  Possible new trials on these interventions should have larger patient samples and include more precise standardization and description of all treatment characteristics.

Sutbeyaz et al (2006) assessed the effect of PEMF on pain, range of motion (ROM) and functional status in patients with cervical osteoarthritis (COA).  A total of 34 patients with COA were included in a randomized, double-blind study, in which PEMF was administrated to the whole body using a mat 1.8 x 0.6 m in size.  During the treatment, the patients lay on the mat for 30 minutes per session, twice a day for 3 weeks.  Pain levels in the PEMF group decreased significantly after therapy (p < 0.001), but no change was observed in the placebo group.  The active ROM, paravertebral muscle spasm and neck pain and disability scale scores improved significantly after PEMF therapy (p < 0.001) but no change was observed in the sham group.  The results of this study are promising, in that PEMF treatment may offer a potential therapeutic adjunct to current COA therapies in the future.

McCarthy and colleagues (2006) noted that the rehabilitation of knee osteoarthritis often includes electrotherapeutic modalities as well as advice and exercise.  One commonly used modality is PEMF.  Its equivocal benefit over placebo treatment has been previously suggested.  However, recently a number of randomized controlled studies have been published that have allowed a systematic review to be conducted.  The authors concluded that this systematic review provides further evidence that PEMF has little value in the management of knee osteoarthritis.  There appears to be clear evidence for the recommendation that PEMF does not significantly reduce the pain of knee osteoarthritis.

Aktas et al (2007) noted that subacromial impingement syndrome (SIS) is a frequent cause of shoulder pain.  In a double-blinded, randomized, and controlled study, these rsearchers examined if PEMF provided additional benefit when used with other conservative treatment modalities in acute phase rehabilitation program of SIS.  A total of 46 patients with unilateral shoulder pain who had been diagnosed as having SIS were included in this trial.  The cases were randomly separated into two groups.  All cases received a treatment program for 3 weeks consisting of Codman's pendulum exercises and subsequent cold pack gel application on shoulders with pain 5 times a day, restriction of daily activities that require the hands to be used over the head, and meloxicam tablet 15 mg daily.  One group was given PEMF; the other group was given sham PEMF daily, 25 minutes per session, 5 days per week for 3 weeks.  Shoulder pain during rest and activity and which causes disturbance of sleep was evaluated using a visual analogue scale, and total Constant score investigated shoulder function.  Daily living activities were evaluated by shoulder disability questionnaire.  Results were assessed before and after treatment.  When compared with the baseline values, significant improvements in all these variables were observed at the end of the treatment in both groups (p < 0.05).  No significant difference between treatments was observed for any of these variables (p > 0.05).  The authors concluded that there is no convincing evidence that PEMF therapy is of additional benefit in acute phase rehabilitation program of SIS.