Self-Administered Electrical Stimulation of the Knee for Relief of Osteoarthritis Pain

Greg Evans September 18th, 2015

Martin Brown*
Utah Pain Management, Farmington, Utah, USA

Demonstrate the objective efficacy of a proprietary, OTC electrotherapy device designed for relief of osteoarthritis of the knee. The Acuknee (FDA and Health Canada cleared) system delivers electrotherapy along known acupuncture points and meridians in a simple, easy to use, reproducible, thirty-minute daily treatment. The principle purpose of this
Investigation was to determine the durability and extent of treatment effects as shown by the highly validated KOOS score (knee osteoarthritis outcome score).

Patients were recruited (n= 45) from Utah Orthopedics (Ogden, Utah) and the Acuknee.com website. Patient recruitment was limited to uncomplicated mild, moderate and severe
Osteoarthritis without coexisting morbidities. Patients with unrepaired meniscal tears, unrepaired torn ligaments, osteochondral defects, implanted cardiac pacemakers or narcotic
usage were excluded. Patients were instructed with a standardized instruction sheet. KOOS data was obtained at time 0 and then at 2, 4 and 8 weeks of a daily, thirty minute,
Self administered treatment. Data was tabulated and presented as individual plot lines for the three categories. Patients were not compensated for their participation.

Results will be presented in graphic format for mild, moderate and severe osteoarthritis of the knee as defined by KOOS score at study entry. X-ray, MRI or physical findings were
not used to classify extent of osteoarthritis. KOOS scores improved from 67 to 92, 48 to 88, and 31 to 67 for mild moderate and severe osteoarthritis, respectively. Improvement
was further shown to be durable after 8 weeks with maintenance therapy. Long term durable pain relief is not generally obtainable with conventional TENS therapy which utilizes a
“Melzack and Wall Gate Theory mechanism”. We believe our mechanism of action is by way of suppression of interleukin-1 as demonstrated by many lines of Chinese and other
electrotherapy interventions. We further see dramatic enhancement of the effect of intraarticular platelet rich plasma when combined with Acuknee pretreatment, presumably by
creating a more permissive biological environment by way of suppression of interleukin-1.

The Acuknee System provided dramatic and durable improvement in uncomplicated osteoarthritis at eight weeks following a single, thirty minute, daily self-administered treatment. Durable, long term relief of knee osteoarthritis symptoms with short duration electrotherapy has heretofore not been presented in the medical literature. The device was well accepted and found to be easy to use by study participants. The Acuknee System provides a viable, low-cost, side effect free treatment for uncomplicated osteoarthritis and may slow or stop the progression of OA. Preliminary follow-on data shows treatment with PRP combined with Acuknee
provides further enhanced durable effects.

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