Battlefield Acupuncture for Chronic Pain

Overseen By Cathy M St Pierre, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edith Nourse Rogers Memorial Veterans Hospital

Must not be taking: Older blood thinners

Disqualifiers: Pregnancy, Bleeding disorders, others

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: 1

Duration: 8 weeks

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Battlefield Acupuncture (BFA) to determine its effectiveness for veterans with chronic pain and a history of substance use disorder. Researchers aim to assess whether BFA can reduce pain and improve mood, sleep, and stress levels over eight weeks. Participants may either start treatment immediately or after a waiting period. Veterans experiencing chronic pain and substance use may qualify if they can commit to 16 weeks of the study. As an unphased trial, this study provides veterans with a unique opportunity to explore innovative pain management techniques.

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

The trial information does not specify whether you need to stop taking your current medications. However, if you are on older blood thinning medications that cause excessive bleeding, you may be excluded from participating.

What prior data suggests that Battlefield Acupuncture is safe for treating chronic pain in veterans?

Research has shown that Battlefield Acupuncture (BFA) is generally safe for managing pain. For instance, one study found that BFA effectively reduces pain without causing serious side effects. Another study confirmed its safety for managing sudden pain and recommended it for mild to moderate pain relief.

These studies have not reported any major negative effects from BFA. Notably, BFA has been successfully used in various situations, such as helping veterans with chronic pain, suggesting it is well-tolerated by users. For those considering joining a trial for BFA, this evidence supports its overall safety for managing chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Battlefield Acupuncture for chronic pain because it offers a non-drug approach that may provide pain relief without the side effects associated with medications like opioids or NSAIDs. Unlike traditional acupuncture, which can involve numerous needles across the body, Battlefield Acupuncture uses only a few needles in specific points on the ear, making it less invasive and potentially more accessible. This technique, originally developed for quick pain relief in military settings, could provide a rapid, alternative method for managing chronic pain in civilian populations as well.

What evidence suggests that Battlefield Acupuncture is effective for treating chronic pain in veterans with a history of substance use disorder?

Research has shown that Battlefield Acupuncture (BFA) can quickly reduce pain. Studies indicate that over 75% of patients experience immediate pain relief after receiving BFA. In one study, about 66% of participants reported a decrease in pain levels right after treatment. Another study found that BFA not only reduced pain but also improved overall quality of life. In this trial, participants will either receive immediate BFA treatment or be placed on a waitlist control before receiving BFA. This suggests BFA could be a promising option for managing chronic pain, especially for veterans. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for veterans aged 18 or older with a history of substance use disorder and chronic pain, who can participate for 16 weeks. It's not suitable for pregnant women, those with ear infections, PICC lines or IV antibiotics, undiagnosed pain, bleeding disorders, or a fear of needles.

Inclusion Criteria

You have a history of addiction to drugs or alcohol.

I have a long-term history of pain.

Availability to participate in the study for 16 weeks

Exclusion Criteria

I am a pregnant female veteran.

I am currently being treated for an ear infection.

I currently have a PICC line or am receiving IV antibiotics.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Battlefield Acupuncture (BFA) treatment for chronic pain over 8 weeks

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluations of stress, mood, and sleep patterns

8 weeks

Monthly evaluations

Waitlist Control

Participants assigned to the waitlist control group receive no active treatment for the first 8 weeks

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Battlefield Acupuncture

Trial Overview

The study tests Battlefield Acupuncture (BFA) on veterans to treat chronic pain and assess its effects on stress, mood, sleep patterns over 8 weeks. Participants will also be evaluated for depression, anxiety and substance use at three different times.

How Is the Trial Designed?

Group I: Waitlist control Experimental Treatment 1 Intervention

Eight weeks of waitlist control and then 8 weeks of weekly treatment

Group II: Immediate treatment Experimental Treatment 1 Intervention

Eight weeks of weekly treatment and then eight weeks of follow up

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?

Edith Nourse Rogers Memorial Veterans Hospital

Lead Sponsor

Trials

8

Recruited

362,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Published Research Related to This Trial

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]

Battlefield acupuncture (BFA) is viewed positively by providers for its ability to effectively control pain and reduce opioid use, making it a valuable nonpharmacological option in the context of the opioid crisis.

However, providers also noted several disadvantages, such as insufficient clinical guidelines and the potential discomfort of the treatment, indicating a need for further research to better understand its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider Perspectives of Battlefield Acupuncture: Advantages, Disadvantages and Its Potential Role in Reducing Opioid Use for Pain. Giannitrapani, KF., Ackland, PE., Holliday, J., et al.[2022]

Battlefield acupuncture, a form of auricular acupuncture, shows promise for treating both acute and chronic pain, with 12 studies involving a total of 12,326 participants indicating positive outcomes, especially in nonrandomized trials.

While no severe adverse events were reported, many randomized trials had a high risk of bias due to lack of blinding, suggesting that more rigorous studies are needed to confirm its efficacy and safety before widespread adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Battlefield Acupuncture as a Treatment for Pain. Salamone, FJ., Federman, DG.[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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7044765/

Battlefield Acupuncture for Chronic Pain Management in ...

Results: Significant average decreases of 1.3 points on the NRS occurred in 66.1% immediately after the procedure. No significant decreases in pain were found.

2.

pmc.ncbi.nlm.nih.gov

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

Patient Feedback on the Effectiveness of Auricular ...

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

3.

cdmrp.health.mil

cdmrp.health.mil/prmrp/research_highlights/22Mao_highlight.aspx

Comparative Effectiveness of Acupuncture for Chronic Pain ...

Both electro-acupuncture and battlefield acupuncture decreased pain severity and improved mental and physical quality of life over time and at a higher rate.

4.

hsrd.research.va.gov

hsrd.research.va.gov/research/citations/PubBriefs/articles.cfm?RecordID=1091

Research Suggests Battlefield Acupuncture is Immediate but ...

BFA produced a minimal clinically important improvement in pain for over half of Veterans receiving it, including patients who recently filled opioid ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2213422024000209

How does pretreatment expectancy influence pain ...

Evidence shows that acupuncture delivers clinically meaningful and durable pain reductions with minimal side effects when compared with usual care or analgesics ...

6.

va.gov

va.gov/wholehealth/professional-resources/clinician-tools/library-research-articles/Battlefield-Acupuncture.asp

Battlefield Acupuncture (BFA) - Whole Health

The aim of this study was to investigate the effectiveness of battlefield acupuncture (BFA) as an adjunct therapy for postoperative pain in US veteran patients.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06874959

Evaluation of the Pain Relief Effect of Battlefield ...

Therefore, the investigators conducted this study to evaluate the effects of BFA combined with electroacupuncture and pain medication on chronic lower back pain ...

8.

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.

9.

frontiersin.org

frontiersin.org/journals/pain-research/articles/10.3389/fpain.2023.1279420/full

Battlefield acupuncture for chronic musculoskeletal pain in ...

BFA reduced pain severity by 2.9 points (95% CI 2.6 to 3.2) after the first session (P < 0.001). After adjusting for baseline pain severity, responders at week ...