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Purpose of Study Study Overview This pilot trial will evaluate a non-invasive, non-significant risk, electromagnetic device therapy as an adjunctive therapy to reduce pain and improve aspects of function such as range of motion, ability to walk distances and perform everyday tasks typically restricted by osteoarthritis of the hip. The device utilizes patented technology involving extremely low level electromagnetic fields (EMF) to provide whole body immersion. EMF treatment with the Resonator™ device is a new technology and has shown promising results in pilot studies of individuals with Parkinson's Disease. In this double-blind, randomized, placebo-controlled pilot trial, the study population consists of male and female adults with pain and reduced function associated with osteoarthritis of the hip. The primary outcome measures are the change in pain level as measured by ratings of pain intensity on a 0 to 100 Visual Analog Scale (VAS); and change in functional performance, such as ability to walk distances and perform everyday tasks typically disrupted by the presence of osteoarthritis of the hip as measured by the Lequesne Index, after 2 weeks of treatment with the Resonator™ compared to baseline. Secondary outcome measures are change in range of motion of the hip joint as measured by physician assessment; changes in pain levels at other body joints as self-rated on a 0 to 10 scale by the subject; and rescue pain medication use as measured through daily pain medication use recording by the subjects. |
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