Physician Clinical Trial Policy (CTP) Neurological Ischemia Lower Extremity Pain and Swelling (DTSC)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01979367 |
Recruitment Status :
Enrolling by invitation
First Posted : November 8, 2013
Last Update Posted : February 9, 2021
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Condition or disease | Intervention/treatment | Phase |
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Lower Extremity Swelling Acute | Device: Anodyne | Not Applicable |
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
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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
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | To Evaluate the Efficacy Treatment of Lower Extremity Pathologies Derived From Neurological Ischemia Disorders |
Study Start Date : | March 2012 |
Estimated Primary Completion Date : | January 2023 |
Estimated Study Completion Date : | March 2024 |
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)
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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. |
- Primary Outcome: Scientific record of treatment success or failure [ Time Frame: 5 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979367
United States, Florida | |
Curequest Clinical LLC | |
Jacksonville, Florida, United States, 32216 | |
United States, Pennsylvania | |
Erie Medical and Rehab | |
Erie, Pennsylvania, United States, 16509 | |
United States, Texas | |
Silsbee Family Medicine PA | |
Silsbee, Texas, United States, 77656 |
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 | |
Principal Investigator: | Doyce Cartrett, M.D. | American Association of Sensory Electrodiagnostic Medicine | |
Principal Investigator: | Donald S Covington, M.D. | American Association of Sensory Electrodiagnostic Medicine |
Responsible Party: | American Association of Sensory Electrodiagnostic Medicine |
ClinicalTrials.gov Identifier: | NCT01979367 |
Other Study ID Numbers: |
DTSC030113 |
First Posted: | November 8, 2013 Key Record Dates |
Last Update Posted: | February 9, 2021 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Ischemia Pathologic Processes Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |