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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores battlefield acupuncture, a form of ear acupuncture, as a new method to ease pain from hidradenitis suppurativa, a skin condition that causes painful lumps. Participants will receive acupuncture treatments to determine their effectiveness in reducing pain, with some receiving real acupuncture and others a sham (fake) version. It is ideal for individuals with dermatologist-confirmed hidradenitis who experience significant pain at least twice a week and are on a stable treatment plan.

As an unphased trial, this study provides a unique opportunity to explore innovative pain relief methods for those seeking new treatment options.

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 prior data suggests that battlefield acupuncture is safe for treating pain in hidradenitis suppurativa?

Research has shown that battlefield acupuncture is generally safe. Studies have found a very low risk of side effects, which are usually mild and temporary. This treatment helps manage pain, including pain from hidradenitis suppurativa, a painful skin condition. In a large study involving over 11,000 Veterans, more than 75% reported immediate pain relief from battlefield acupuncture. This finding suggests the treatment is not only safe but also effective for reducing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Battlefield Acupuncture is unique because it offers a non-invasive alternative to traditional treatments for Hidradenitis Suppurativa (HS), which often include antibiotics, anti-inflammatory drugs, or even surgery. Unlike these options, which can have significant side effects or require lengthy recovery times, Battlefield Acupuncture uses strategically placed ear acupuncture to potentially relieve pain and inflammation. Researchers are excited about this treatment because it could provide rapid symptom relief without the need for medication, making it an appealing option for those seeking a more natural and holistic approach to managing HS.

What evidence suggests that battlefield acupuncture is effective for the pain of hidradenitis suppurativa?

Research has shown that battlefield acupuncture, one of the treatments under study in this trial, can help reduce pain. In one study, 82% of patients experienced less pain after this treatment. Additionally, more than three-quarters of patients reported immediate relief, and nearly 60% noted significant improvement. This type of acupuncture, often used in the military, shows promise for quick pain management. While more research is needed specifically for hidradenitis suppurativa, these results offer encouragement for those seeking pain relief. Participants in this trial may receive either battlefield acupuncture or sham acupuncture as a control. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1.

withpower.com

withpower.com/trial/phase-hidradenitis-2020-3b2f0

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 ...

2.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT04218422/battlefield-acupuncture-for-pain-in-hidradenitis-suppurativa

Battlefield Acupuncture for Pain in Hidradenitis Suppurativa

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

3.

jintegrativederm.org

jintegrativederm.org/doi/10.64550/joid.46083j25

A Systematic Review: Hidradenitis suppurativa is a chronic ...

Heshi-fire needling and battlefield acupuncture are forms of TCM that have been used in HS and need further studies to determine true efficacy.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7497594/

Patient Feedback on the Effectiveness of Auricular ...

More than 3 quarters experienced immediate decreases in pain following administration of BFA, with nearly 60% reported experiencing a minimal clinically ...

5.

research.va.gov

research.va.gov/currents/0821-Battlefield-acupuncture.cfm

Battlefield acupuncture

The investigators found a decrease in pain in 82% of patients, on average, including patients seen in group settings and those seen in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12094825/

Practical Applications and Safety of Battlefield Acupuncture for ...

Evidence supports the efficacy and safety of BFA for acute pain. The utilisation of BFA in the context of alleviating mild to moderate pain is recommended.

7.

withpower.com

withpower.com/trial/phase-chronic-pain-10-2023-429c5

Battlefield Acupuncture for Chronic Pain

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 ...