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

Not Applicable

• Conditions: Lower Extremity Swelling Acute
• Interventions: Device: Anodyne

• Registration Number: NCT01979367
• Lead Sponsor: American Association of Sensory Electrodiagnostic Medicine

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05
• Primary Completion: 2026-01
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anodyne	Anodyne	To evaluate the efficacy treatment of lower extremity pathologies from neurological ischemia disorders using the Monochromatic Infrared Photo Energy (MIRE)

Primary Outcome Measures

Name	Time	Method
Primary Outcome: Scientific record of treatment success or failure	5 years

Trial Locations

Locations (1)

Erie Medical and Rehab; 🇺🇸 Erie, Pennsylvania, United States