The FDA has cleared an over-the-counter (OTC) drug-free pain therapy for pain related to plantar fasciitis of the heel and osteoarthritis of the knee.
FDA Clears Drug-Free Pain Therapy for Plantar Fasciitis and Osteoarthritis
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Secondary
The therapy is a wearable non-prescription medical device called ActiPatch from BioElectronics Corp.
The company develops wearable, neuromodulation devices to mitigate neurologic diseases and, according to the company, to safely improve quality of life. Its pulsed shortwave therapy technology (PSWT) uses low-power, pulsed electromagnetic fields to regulate electrical activity of the nervous system.
The company says the device provides 720 hours (90, 8-hour treatments) of on/off therapy. Most users obtain relief with only 8 hours per day of use, and the device generally last several months, depending on use. ActiPatch is described by BioElectronics as “an adjunctive or alternative therapy to pain killers, including narcotics.”
According to a February 2017 company press release, ActiPatch Provides:
- Impressive efficacy
- No harmful side effects
- A 50% reduction in medication Use, including opioids
- Exceptional consumer acceptance
- Demonstrated marketability
- An adjunctive or alternative therapy to pain killers, including narcotics.
The company’s current OTC product line includes the ActiPatch Musculoskeletal Pain Therapy, Allay Menstrual Pain Therapy, Smart Insole Heel Pain Therapy, and RecoveryRx Post-operative and Chronic Wounds Therapy.
Clinical Evidence
The company’s website cites a clinical study published on December 24, 2015 by Rheumatology. The study tested the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients.
Sixty-six patients were included, and 60 completed the study. After 1 month, according to the company, “PEMF induced a significant reduction in VAS (Visual Analog Scale) pain and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores compared with placebo. Additionally, pain tolerance, as expressed by PPT changes, and physical health improved in PEMF-treated patients. A mean treatment effect of -0.73 (95% CI – 1.24 to – 0.19) was seen in VAS score, while the effect size was -0.34 (95% CI – 0.85 to 0.17) for WOMAC score. Twenty-six per cent of patients in the PEMF group stopped NSAID/analgesic therapy. No adverse events were detected.”
The ActiPatch costs $30 retail.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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