Physician Clinical Trial Policy (CTP) Neurological Ischemia Lower Extremity Pain and Swelling

Although there are a number of pain disorders, associated with back, or lower extremity pain
and swelling, the American Association of Sensory Electrodiagnostic Medicine (AASEM/ DTSC)
study programs will accumulate received data following a protocol of treatment performed for
the purpose of eliminating pain, reducing swelling, and accelerating recovery periods as well
as to record the success or failure and/or improvement of the malfunctioning body part.

- Condition: Neuropathic Pain, Tingling or Numbness derived from neurological Ischemia

- Intervention: Treatments of Monochromatic Infrared Photo Energy (MIRE) in combination
with Electronic Signal Treatment (TENS) therapy

- Study Type: Interventional

- Study Design:

1. Allocation: Non-Randomized

2. Endpoint Classification: Efficacy Study

3. Intervention Model: Single Group Assignment

4. Masking: Open Label

5. Primary Purpose: Scientific record of treatment success or failure

Inclusion Criteria:

- In the investigator's judgment, a high probability of 5 year survival and compliance
with the study visit schedule.

Ability to comprehend and sign an informed consent document prior to study enrollment.

Exclusion Criteria:

- Any other excluding factors that, according to the investigator's judgment, would
preclude enrollment in the study.