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Physician Clinical Trial Policy (CTP) Neurological Ischemia Lower Extremity Pain and Swelling
Sponsor: American Association of Sensory Electrodiagnostic Medicine
Summary
Physician Clinical Trial Policy (CTP) to evaluate the efficacy treatment of lower extremity pathologies derived from neurological ischemia disorders using the combination of Monochromatic Infrared Photo Energy (MIRE) and Transcutaneous Electrical Nerve Stimulation (TENS) therapies.
Official title: To Evaluate the Efficacy Treatment of Lower Extremity Pathologies Derived From Neurological Ischemia Disorders
Key Details
Gender
All
Age Range
25 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2012-03
Completion Date
2027-01
Last Updated
2025-10-08
Healthy Volunteers
No
Conditions
Interventions
Anodyne
Subjects will be treated with MIRE therapy using the Anodyne® device within 72 hours of previous treatments, and in accordance with the Anodyne® package insert indications for use 30 to 45 minutes professional units on power setting of 8,. In addition, patients will undergo TENS therapy with the use of either the Avazzia® Pro Sport or TENS 3000 (for no less than 30 mins, both on label) in accordance with the indications for use of each TENS device, 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 (NCS) test performed.