Anodyne Therapy for Lower Extremity Ischemic Pain

(DTSC Trial)

Not currently recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: American Association of Sensory Electrodiagnostic Medicine

Disqualifiers: Neurological ischemia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for leg pain caused by poor blood flow, focusing on two therapies: Anodyne Therapy (a type of Monochromatic Infrared Photo Energy, MIRE) and Transcutaneous Electrical Nerve Stimulation (TENS). The goal is to evaluate how well these therapies work together in reducing pain from neurological ischemia disorders, which affect blood and nerve function. It suits individuals with persistent leg pain due to circulation issues who can commit to regular study visits. Participants must understand and sign a consent form before joining. As an unphased trial, this study offers a unique opportunity to explore innovative therapies for leg pain relief.

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.

What prior data suggests that this therapy is safe for treating lower extremity ischemic pain?

Research shows that Anodyne Therapy, which uses a special type of infrared light, is generally safe. Studies have found that this therapy can increase blood flow and reduce pain without surgery. The FDA approved the Anodyne Therapy System for use in 1994, highlighting its safety. Researchers have studied these infrared devices for various conditions, such as diabetic nerve pain and skin ulcers, indicating their broad safety. Although detailed information on side effects isn't provided, the FDA approval and use for different conditions suggest that any side effects are likely minor or manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Anodyne therapy is unique because it uses Monochromatic Infrared Photo Energy (MIRE) to target lower extremity ischemic pain, which is pain caused by reduced blood flow to the legs. Unlike standard treatments that primarily focus on medication or surgery to improve blood circulation, Anodyne therapy directly uses infrared light to boost blood flow and reduce pain at the neurological level. Researchers are excited about this approach because it represents a non-invasive option that could offer faster relief with fewer side effects, potentially making it a game-changer for patients who cannot undergo surgery or tolerate traditional medications.

What evidence suggests that Anodyne therapy might be an effective treatment for lower extremity ischemic pain?

Research has shown that Anodyne therapy, which uses infrared light, can improve blood flow and reduce pain. Studies have found that it enhances sensation in the legs and feet, eases pain, and even aids balance, potentially lowering the risk of falls. In nearly 5,000 patients, this therapy was linked to pain relief. It also reduced pain levels and improved sleep quality in individuals with severe pain. These findings suggest that Anodyne therapy, which participants in this trial will receive, could effectively treat pain in the legs and feet caused by poor blood flow and nerve issues. ^{1 2 3 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-ischemia-2-2012-35eb8

Anodyne Therapy for Lower Extremity Ischemic Pain · Info ... Anodyne therapy is unique because it uses infrared light to increase circulation and reduce pain, unlike other treatments that may involve surgery or ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01979367

Physician Clinical Trial Policy (CTP) Neurological Ischemia ... To evaluate the efficacy treatment of lower extremity pathologies from neurological ischemia disorders using the Monochromatic Infrared Photo Energy (MIRE).

3. anodynetherapy.com anodynetherapy.com/clinical-evidence/

Anodyne Therapy | Clinical Evidence Training 25 studies published since 1999 in noted medical journals show the pain relieving benefits of the Anodyne Therapy Systems in nearly 5,000 patients. Anodyne ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK76072/

Effectiveness of the anodyne therapy system in treating ... - NCBI Anodyne therapy system treatment may be effective for improving lower extremity sensation, reducing pain, improving standard balance and decreasing fall risk.

5. painmanagementnursing.org painmanagementnursing.org/article/S1524-9042(24)00251-0/fulltext

Effects of Monochromatic Infrared Light on Painful Diabetic ... Pain intensity was lower and sleep quality improved (p < .001) for the experiment group, especially in people with severe pain. Conclusions. 890 ...

6. activehealth.com activehealth.com/content/2022/07/Anodyne-Therapy-AHM-1.pdf

Anodyne Therapy AHM The Anodyne Therapy System is a type of low-level infrared therapy, developed by Integrated Systems Physiology Inc. of Aurora, CO, that has been promoted for ...

7. bcbsm.com bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/82722.pdf

MONOCHROMATIC INFRARED ENERGY (MIRE) DEVICE ... MIRE devices have been investigated as a treatment of multiple conditions including cutaneous ulcers, diabetic neuropathy, musculoskeletal ...