Battlefield Acupuncture for Chronic Lower Back Pain

Overseen By Korey Kennelty, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stephanie K. Bunt

Disqualifiers: Prior BFA treatment, Dementia

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: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if Battlefield Acupuncture, an ear-based treatment, can reduce chronic lower back pain in older adults living in retirement communities. The focus includes improving pain levels, reducing pain medication use, and enhancing mobility and overall well-being. Researchers will test the effectiveness and ease of using this treatment in a group setting. This trial suits individuals over 65 with chronic lower back pain living at Oaknoll Community Center who have some mobility. As an unphased trial, it provides a unique opportunity to explore a non-invasive treatment option that could enhance quality of life.

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

The trial does not specify if you need to stop taking your current medications. It seems to be designed to complement existing treatments, so you may not need to stop them.

What prior data suggests that this Battlefield Acupuncture protocol is safe for older adults with chronic lower back pain?

Research has shown that Battlefield Acupuncture (BFA) is generally safe and well-tolerated. Studies have found it effective in reducing pain, particularly for military personnel and veterans, without major risks. Evidence suggests BFA provides a quick and affordable method for managing chronic pain, offering a safer alternative to opioids, which can cause addiction and other side effects. Although BFA is not yet common among older adults in long-term care facilities, its successful use in various settings supports its safety for pain management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Battlefield Acupuncture is unique because it offers a non-drug approach to managing chronic lower back pain. Unlike standard treatments like pain relievers, physical therapy, or surgery, this technique involves placing small needles in specific points on the ear, which can potentially reduce pain quickly and with fewer side effects. Researchers are excited about this treatment because it targets the body's natural pain-relief pathways, offering a promising alternative for those who may not respond well to traditional methods.

What evidence suggests that Battlefield Acupuncture is effective for chronic lower back pain?

Research has shown that Battlefield Acupuncture (BFA), which participants in this trial will receive, can help manage chronic pain. In one study, 82% of patients reported a decrease in pain immediately after receiving BFA. Another study found that BFA has been well-researched and could help with both short-term and long-term pain. Many patients experienced relief for up to 30 days after treatment. This suggests that BFA might be a good option for easing chronic lower back pain, especially in older adults. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 65 with chronic lower back pain who live at the Oaknoll Community Center and can move around (with or without help). They must be patients of UIHC. People with a history of battlefield acupuncture treatment or diagnosed dementia cannot participate.

Inclusion Criteria

I have long-term lower back pain from a muscle or bone condition.

I am over 65 years old and live at the Oaknoll Community Center.

UIHC patient

Exclusion Criteria

I have previously received BFA acupuncture treatment.

You have been diagnosed with dementia.

Anyone not meeting inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Participants receive weekly SMS prompts to report pain levels and other data for 12 weeks

12 weeks

Weekly SMS prompts

Treatment

Participants undergo group Battlefield Acupuncture sessions every other week

12 weeks

6 in-person sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Battlefield Acupuncture

Trial Overview The study tests group Battlefield Acupuncture, an ear-based acupuncture method, to see if it helps older adults in retirement communities manage chronic lower back pain better than current treatments. It will look at how feasible and satisfying this approach is for participants.

How Is the Trial Designed?

Group I: Acupuncture Arm Experimental Treatment 3 Interventions

No control

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?

Stephanie K. Bunt

Lead Sponsor

Trials

1

Recruited

20+

Korey Kennelty

Lead Sponsor

Trials

4

Recruited

1,300+

Published Research Related to This Trial

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 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]

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 (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]

A systematic review of 15 studies found that auricular acupuncture was effective in reducing pain intensity in chronic back pain patients, with positive results in 80% of the studies analyzed.

Despite its effectiveness, there is a lack of standardized protocols for applying auricular acupuncture, highlighting the need for more consistent methods in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for chronic back pain in adults: a systematic review and metanalysis. Moura, CC., Chaves, ECL., Cardoso, ACLR., et al.[2022]

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 ... The researchers reported an immediate decrease in self-reported pain in 82% of patients, with no change in 9.7% of the patients, and an increase in pain in 8.3% ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06874959

Evaluation of the Pain Relief Effect of Battlefield ... Currently, this method has been extensively researched and has shown its potential in both acute and chronic pain, such as chronic musculoskeletal pain in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S073567571830175X

Battlefield acupuncture to treat low back pain in the ... The study hypothesis is that ear acupuncture will improve pain and mobility of patients that present with low back pain to the ED, and that the modality would ...

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

Battlefield Acupuncture (BFA) - Whole Health The large proportion of patients reporting decreased pain even 30 days after treatment suggests that the long-term effect of BFA merits further investigation.

5. journals.lww.com journals.lww.com/lww-medicalcare/fulltext/2020/09001/patient_feedback_on_the_effectiveness_of_auricular.8.aspx

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 ...

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

Battlefield acupuncture In reducing Veterans' pain while also lessening risk, VA offers battlefield acupuncture among other non-medication alternatives. These ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02399969

Battlefield Acupuncture for the Treatment of Low Back Pain ... The purpose of this study is to study acupuncture for the treatment of low back pain in the emergency department. Current treatments for low back pain in ...