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

Lower Extremity Swelling Acute Clinical Trial

— DTSC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01979367
• Other study ID #: DTSC030113
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 2012
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: American Association of Sensory Electrodiagnostic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: March 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Lower Extremity Swelling Acute

Intervention

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.

Locations

Country	Name	City	State
United States	Erie Medical and Rehab	Erie	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
American Association of Sensory Electrodiagnostic Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome: Scientific record of treatment success or failure		5 years