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Extremities Feature

ActiPatch / Courtesy of BioElectronics Corp

FDA Clears Drug-Free Pain Therapy for Plantar Fasciitis and Osteoarthritis

Walter Eisner • Wed, April 12th, 2017

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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.

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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Comments

13 Responses to “FDA Clears Drug-Free Pain Therapy for Plantar Fasciitis and Osteoarthritis”

  1. R Anders says:

    I have been using the ActiPatch for 7 years to relieve shoulder and low back pain. It is a great that US pain sufferers now have access to this drug free pain relief product.

  2. Yevonne Stallings says:

    Where can you purchase

    • R Anders says:

      Yevonne, The ActiPatch will not be in drug stores until September due to shelf space allotments but it is available online. Contact the company at Bioelectronics Corp.com.

  3. There some ppl.especially older ppl who have many injuries that failed all type of treatment for chronic pain.Ive got injuries from my neck that effects my shoulders head neck & arms low back that goes to my tailbone.from testing on my neck. A mylogram, injected in my low back , injuries my back.Then in 05 I had leg saving surgery.Major fractured long bones in my rt leg & both heads of upper & lower bones heads were buster into 8-9 pieces ,major miniscus damage & muscle damage all due to 2 hospitals turned me away because I had out of state Medicaid .took 3 rides to local pa. Hospitals where my knee had blown up so lg. With blood that it stopped my pulse in my ankle..I’ve been a perfect pain patient from 1997 failed neck surgery,low back injury & 2005 leg saving surgery .Due to DEA I’m stuck in bed in chronic pain 24-7 days.Cant eat or sleep! Pain putting me insane!!! Why must I suffer 20 yrs.till I die? I’m 60 yr old chronicpain patient who always did what dr told me,never dr shopped used same pharmacy 20 yrs.never been in any legal problems & Now I’m made to suffer with no relief until I die? DEA thinks everyone can be cured with therapy, there allto scared to treat real pain patients like me(also have osteoporosis to add to my back pain.Omly help I ever got was opiates after TO many surgeries ! DEA knows nothing about medical treatment but rules over dr who invested many yrs to treat chronic patients but now aren’t allowed by law of DEA! In 20 yrs of pain relief I’ve never OVERDOSED . ITS PPL WHO DONT FOLLOW DR ORDER, why must I suffer until I die,at age 60.???

  4. Mar Dannell says:

    I’ve had a box in my back for 10 yrs, it’s supose to get my mind off the pain, no matter how much it sent shocks thru my back, IT DON’T WANT!!!!!!!!

  5. Karen Gray says:

    I would like info on this!!!!

    • R Anders says:

      Karen, Please visit the company’s website, Bioelectronics Corp.com. They have dozens of pages explaining the science behind the ActiPatch and the Clinical Trials that confirmed it as a safe and effective pain reliever

  6. Nancy Jones says:

    Sounds great but people like me can’t afford to get it,on medicad. Have had shots in my heel doesn’t feel good at all, but cost me $3.50 .Not proud but also have nerve damage in low back, which effects my hips and knees.so I use pain medication.just to enjoy my life to walk the dog and play with grandchildren.Now thanks to government want to,stop me from having a life

  7. Lilly Rivera says:

    Where can it bought at is it in stores

    • R Anders says:

      Lilly, The ActiPatch was just Cleared by the FDA in February so it will be a few months before it is in stores. You can purchase one right now online. Please contact the company, just enter “Bioelectronics Corp” in Google and it will be the first one that is listed.

  8. Dennis DiLullo says:

    Hi is there any way of me receiving one of those for free by mail? I have spinal cord problems and I’d like to see if it would help me out.
    Thanks,
    Dennis DiLullo

    • R Anders says:

      Dennis, I am not aware of any Free Sample Programs at this time but there is a 7 Day Trial ActiPatch available for $9.95. Contact the company at Bioelectronics Corp.com.

  9. Grace says:

    I had surgery in 2010 have metal in my back I do not take any drugs for pain just have to live with it also have a bad knee but do not have money to have it fix I’m on fix income and have to wait until I’m 65 years old to have anything done will this help my knee and back I know it’s not a lot of money but when you live off 700.00 a month it is thank you

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