Anodyne Therapy for Lower Extremity Ischemic Pain

(DTSC Trial)

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: American Association of Sensory Electrodiagnostic Medicine

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is evaluating whether a combination of infrared light and electrical nerve stimulation can help treat lower extremity pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial investigator for guidance.

How does Anodyne therapy differ from other treatments for lower extremity ischemic pain?

Anodyne therapy is unique because it uses infrared light to increase circulation and reduce pain, unlike other treatments that may involve surgery or medication. This non-invasive approach can be particularly beneficial for patients who cannot undergo surgical procedures. ^{1 2 3 4 5}

Research Team

Michael Boyer, M.D.

Principal Investigator

American Association of Sensory Electrodiagnostic Medicine

Chad Pfefer, M.D.

Principal Investigator

American Association of Sensory Electrodiagnostic Medicine

Eligibility Criteria

This trial is for individuals with lower extremity pain and swelling due to ischemia, who are likely to live at least 5 more years and can follow the study schedule. They must understand and sign a consent form. People may be excluded based on other factors that could affect their participation as judged by the investigator.

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

The doctor thinks there are other reasons why you shouldn't participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Monochromatic Infrared Photo Energy (MIRE) and Transcutaneous Electrical Nerve Stimulation (TENS) therapies to treat lower extremity pathologies derived from neurological ischemia disorders

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Anodyne

Trial Overview The trial is testing how well Monochromatic Infrared Photo Energy (MIRE) combined with Transcutaneous Electrical Nerve Stimulation (TENS) therapies work in treating leg pain and swelling caused by neurological ischemia.

Participant Groups

Group I: Anodyne Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

American Association of Sensory Electrodiagnostic Medicine

Lead Sponsor

Trials

2

Recruited

2,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic limb ischemia. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

[Acute limb ischemia from the general surgeon's point of view. How much knowledge of vascular surgery is necessary?]. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

[The role of spinal cord electric stimulation in critical ischemia of the extremity]. [2006]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Epidural spinal cord stimulation in the treatment of severe peripheral arterial occlusive disease. [2022]

5. France pubmed.ncbi.nlm.nih.gov

[Electric stimulation of the spinal cord in arterial diseases of the legs. A multicenter study of 244 patients]. [2022]