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

To Evaluate the Efficacy Treatment of Lower Extremity Pathologies Derived From Neurological Ischemia Disorders

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lower Extremity Swelling Acute
• Intervention / Treatment: Device: Anodyne

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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16509
      • Erie Medical and Rehab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Anodyne; To evaluate the efficacy treatment of lower extremity pathologies from neurological ischemia disorders using the Monochromatic Infrared Photo Energy (MIRE)

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary Outcome: Scientific record of treatment success or failure	5 years

Collaborators and Investigators

• Sponsor: American Association of Sensory Electrodiagnostic Medicine
• Investigators: Study Director: Michael Boyer, M.D., American Association of Sensory Electrodiagnostic Medicine; Principal Investigator: Danielle Sanders, M.D., American Association of Sensory Electrodiagnostic Medicine; Study Chair: Chad Pfefer, M.D., American Association of Sensory Electrodiagnostic Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimated): November 8, 2013

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: DTSC030113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes