Battlefield Acupuncture for Hidradenitis Suppurativa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wayne State University

Disqualifiers: Ear disfigurement, Other chronic pain

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

32 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial requires that you stay on your current treatment plan for hidradenitis suppurativa during the study.

What data supports the effectiveness of the treatment Battlefield Acupuncture for Hidradenitis Suppurativa?

Battlefield Acupuncture has been shown to provide immediate pain relief in veterans and is used effectively for managing pain in military settings, including conditions like muscle and back pain. While specific data for Hidradenitis Suppurativa is not available, its success in pain management for other conditions suggests potential benefits. ^{1 2 3 4 5}

Is Battlefield Acupuncture safe for humans?

Battlefield Acupuncture is generally considered safe for humans, with very low risk and only mild, temporary side effects reported in studies. ^{1 3 5 6 7}

How is Battlefield Acupuncture different from other treatments for Hidradenitis Suppurativa?

Battlefield Acupuncture is unique because it is a non-drug treatment that involves placing small needles in specific points on the ear to manage pain. It is quick to administer, can be performed by non-specialists, and has minimal risk of side effects, making it a novel option compared to traditional pain management methods. ^{1 2 3 4 6}

What is the purpose of this trial?

The investigators will investigate battlefield acupuncture as a treatment for the pain of hidradenitis suppurativa.

Eligibility Criteria

This trial is for adults over 18 with a dermatologist-confirmed diagnosis of hidradenitis suppurativa, experiencing significant pain from the condition at least twice weekly. Participants must be on a stable treatment regimen for hidradenitis during the study and have no other chronic pain or ear issues that would interfere with acupuncture.

Inclusion Criteria

I experience significant pain from hidradenitis at least twice a week.

My treatment for hidradenitis will not change during the study.

I have been diagnosed with hidradenitis suppurativa by a dermatologist.

Exclusion Criteria

I cannot have acupuncture on my ears due to a condition or disfigurement.

I do not have chronic pain that would affect my ability to assess my hidradenitis pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive battlefield acupuncture to the bilateral ears, with treatments spaced one week apart

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in pain levels after treatment

2 weeks

Treatment Details

Interventions

• Battlefield Acupuncture
• Sham Acupuncture

Trial Overview The trial is testing battlefield acupuncture against sham (fake) acupuncture to see if it can reduce pain in patients with hidradenitis suppurativa. Battlefield acupuncture involves placing tiny needles in specific points on the ear.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

2 treatments of battlefield acupuncture to the bilateral ears spaced one week apart

Group II: Control Placebo Group 1 Intervention

2 treatments with sham acupuncture to the bilateral ears at acupuncture points not associated with pain relief (2 liver and 1 stomach)

Battlefield Acupuncture is already approved in United States for the following indications:

Approved in United States as Battlefield Acupuncture for:

• Chronic pain
• Anxiety
• Insomnia
• Low back pain
• Headaches
• Arthritis
• Fibromyalgia
• Joint pain
• Hidradenitis suppurativa

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

Findings from Research

Over 75% of the 11,406 Veterans treated with Battlefield Acupuncture (BFA) reported immediate pain relief, with an average decrease in pain intensity of -2.5 points after the first treatment.

BFA was effective for a diverse group of Veterans, including those with chronic pain and other comorbid conditions, although those with recent opioid use showed less improvement in pain scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Feedback on the Effectiveness of Auricular Acupuncture on Pain in Routine Clinical Care: The Experience of 11,406 Veterans. Zeliadt, SB., Thomas, ER., Olson, J., et al.[2022]

Battlefield acupuncture is being utilized in military medical facilities to provide nonpharmacologic pain management for warriors suffering from conditions like polytrauma, PTSD, and muscle pain, highlighting its potential effectiveness in treating pain without opioids.

The implementation of battlefield acupuncture involves training funded by the DoD and VA, emphasizing a collaborative approach to pain management and the integration of this technique into medical education for future healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Battlefield acupuncture: Opening the door for acupuncture in Department of Defense/Veteran's Administration health care. Walker, PH., Pock, A., Ling, CG., et al.[2017]

Battlefield acupuncture is a quick and effective pain management technique that can be performed by nonacupuncturists, making it accessible in both military and civilian healthcare settings.

This method has a very low risk of adverse reactions, suggesting it can be safely used as an alternative or complement to traditional pain management therapies, although more large randomized controlled trials are needed to confirm its efficacy compared to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating pain using acupuncture for nonacupuncturists. Toney, B.[2023]

Battlefield Acupuncture (BFA) is a rapid and safe technique that uses five needles placed in specific points on the ear to effectively treat both acute and chronic pain, making it suitable for military deployment.

The implementation of BFA, supported by a $5.4 million Joint Incentive Fund, led to the training of thousands of healthcare providers and initiated numerous clinical trials to validate its efficacy, highlighting its potential as a valuable pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Battlefield Acupuncture Through a Large Medical System: Overcoming Barriers. Niemtzow, RC.[2021]

Among Veterans who received Battlefield Acupuncture (BFA), 9.5% went on to use traditional acupuncture, compared to only 0.9% of those who did not receive BFA, indicating a significant increase in subsequent acupuncture use.

Veterans who used BFA had 10.9 times greater odds of trying traditional acupuncture afterward, suggesting that BFA not only provides immediate pain relief but also encourages patients to explore further nonpharmacologic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Offering Battlefield Acupuncture Lead to Subsequent Use of Traditional Acupuncture? Thomas, ER., Zeliadt, SB., Coggeshall, S., et al.[2023]

In a pilot study involving 30 patients with acute low back pain, battlefield acupuncture (BFA) combined with standard care significantly reduced pain levels compared to standard care alone, with a pain rating of 5.2 versus 6.9 on a 10-point scale.

No adverse events were reported from the acupuncture treatment, indicating that BFA is a safe and feasible option for managing acute low back pain in the emergency department setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Battlefield acupuncture to treat low back pain in the emergency department. Fox, LM., Murakami, M., Danesh, H., et al.[2019]

Battlefield Acupuncture (BFA) is a safe and easy-to-learn technique used for pain management, with few mild and temporary adverse effects reported.

However, a review of nine randomized controlled trials involving 344 participants found that BFA did not significantly improve pain intensity compared to control groups, indicating a need for higher-quality studies to better assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Battlefield Acupuncture for Adult Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Yang, J., Ganesh, R., Wu, Q., et al.[2021]

References

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

Patient Feedback on the Effectiveness of Auricular Acupuncture on Pain in Routine Clinical Care: The Experience of 11,406 Veterans. [2022]

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

Battlefield acupuncture: Opening the door for acupuncture in Department of Defense/Veteran's Administration health care. [2017]

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

Treating pain using acupuncture for nonacupuncturists. [2023]

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

Implementing Battlefield Acupuncture Through a Large Medical System: Overcoming Barriers. [2021]

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

Does Offering Battlefield Acupuncture Lead to Subsequent Use of Traditional Acupuncture? [2023]

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

Battlefield acupuncture to treat low back pain in the emergency department. [2019]

7. Singapore pubmed.ncbi.nlm.nih.gov

Battlefield Acupuncture for Adult Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2021]