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

Trial Summary

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 data supports the effectiveness of the treatment Battlefield Acupuncture for chronic pain?

Research involving over 12,000 veterans showed that Battlefield Acupuncture, a type of ear acupuncture, can provide immediate pain relief. Additionally, several studies found positive outcomes for pain management, although more high-quality research is needed to confirm these findings. ^{1 2 3 4 5}

Is Battlefield Acupuncture safe for humans?

Battlefield Acupuncture is considered to have a very low risk and a negligible adverse reaction profile, with any reported side effects being mild and temporary. ^{1 2 3 4 6}

How is Battlefield Acupuncture different from other treatments for chronic pain?

Battlefield Acupuncture is unique because it is a specific ear acupuncture technique that can be quickly administered by non-specialists, offering immediate pain relief without the use of drugs, making it a low-risk alternative or complement to traditional pain management methods. ^{1 2 3 4 7}

What is the purpose of this trial?

This research study will evaluate the effectiveness of utilizing Battlefield Acupuncture (BFA) on veterans with with a history of substance use disorder and chronic pain for 8 weeks. Primary Aim: The primary aim of this study is to evaluate the effectiveness of using BFA to treat chronic pain in veterans with a history of substance use disorder. Secondary Aim: This study will also evaluate the impact that BFA treatment for pain may have on subjects' stress, mood and sleep patterns over 8 weeks. In addition, each subject will be complete behavioral research tools to measure: depression, anxiety, and substance use at 3 different points in this study. Hypothesis: The use of BFA on veterans with chronic pain will decrease their pain and substance use and improve their quality of life.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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 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 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]

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]

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]

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

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

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

Treating pain using acupuncture for nonacupuncturists. [2023]

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

Provider Perspectives of Battlefield Acupuncture: Advantages, Disadvantages and Its Potential Role in Reducing Opioid Use for Pain. [2022]

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

Battlefield Acupuncture as a Treatment for Pain. [2021]

6. Singapore pubmed.ncbi.nlm.nih.gov

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

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

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