Active, Not Recruiting

NCT Number: NCT01979367

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Lower Extremity Swelling Acute

Age range

25 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Scientific record of treatment success or failure

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anodyne

Device

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.

Primary outcomes

Primary Outcome: Scientific record of treatment success or failure

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

American Association of Sensory Electrodiagnostic Medicine

Industry

Registry information

Official study title

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

Acronym: DTSC

Important dates

Study start: 2012
Primary completion: 2027
Study completion: 2027
First posted: Nov 8, 2013
Registry last updated: Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.