Medicare Study for Lower Extremity Pain

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What Type Of Study Will I Be Participating In?

The Physician Clinical Trial Policy (PCTP) will evaluate the efficacy treatment of lower extremity pathologies derived from neurological ischemia disorders using the combination of injections, Monochromatic Infrared Photo Energy (MIRE) and Transcutaneous Electrical Nerve Stimulation (TENS) therapies.

Patients that are accepted into the study will be treated with MIRE therapy using the Anodyne device within 72 hours of previous treatments, in accordance with the Anodyne insert indications for use 30 to 45 minutes. In addition, the patients will undergo TENS treatment for a minimum of 15 minutes at the subjective site for pain and each vertebrae nerve base, when impairment is confirmed with the objective Small Pain Fiber (SPF) Nerve Conduction Study test performed.

This study is sponsored by the American Association of Sensory Electrodiagnostic Medicine.

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Who is Eligible to Participate in the lower extremity pain Study?

All Medicare participants are eligible to be screened and those that meet the criteria will have an opportunity to be enrolled in the study. This study is sponsored by the American Association of Sensory Electrodiagnostic Medicine and, if qualified, will be covered by Medicare. Patients that exhibit lower extremity pain, numbness and tingling, weakness, loss of balance, or pain derived from neurological ischemia are eligible.

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