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

20 Participants Needed

Trial Summary

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

Research shows that Battlefield Acupuncture, a type of ear acupuncture, is effective for immediate pain relief in various settings, including military and civilian environments. It has been used successfully for pain management in veterans and is considered a low-risk alternative to traditional pain treatments. ^{1 2 3 4 5}

Is Battlefield Acupuncture safe for humans?

Battlefield Acupuncture is considered very safe with a very low risk of adverse reactions, which are usually mild and temporary. ^{2 3 4 5 6}

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

Battlefield Acupuncture is unique because it involves placing small needles in specific points on the ear to quickly relieve pain, and it can be performed by non-specialists, making it accessible in various settings. Unlike many pain treatments, it does not involve medication, reducing the risk of side effects and dependency. ^{2 3 4 5 7}

What is the purpose of this trial?

Lower back pain (LBP) is one of the most common causes of disability, with 68% of adults over 60 years of age suffering from chronic Lower Back Pain (cLBP). In addition to the exacerbation of physical, social and emotional health issues, LBP has a staggeringly high US economic burden. Community-dwelling older adults experience a significant amount of chronic pain and treatments that are effective in their younger adult counterparts (e.g., pain medications, exercise) are often not safe or feasible. Our long-term goal is to decrease cLBP and improve function in older adults residing in continuing care retirement communities (CCRC). Battlefield Acupuncture (BFA), a promising treatment for cLBP, is an auricular (ear-based) treatment intended to compliment traditional allopathic medical treatments for acute and chronic pain. Auricular acupuncture has been implemented and used widely in the US military. Despite emerging evidence supporting the use of BFA in chronic pain, BFA has not been used to treat older adults with cLBP residing in CCRC. To this end, we propose an adapted group BFA protocol for CCRC residents. We will determine the feasibility and acceptability of implementing group BFA for cLBP at the University of Iowa (UI) Family Medicine-affiliated CCRCs by evaluating patient participation rates and retention, comfort with the protocol and satisfaction with the sessions, protocol delivery and ease of use. We will also determine treatment effectiveness by evaluating pain scales in cLBP, pain medication use, mobility, and falls. Data obtained from this study will inform the design of a future clinical trial testing group BFA for the management of cLBP in older adults.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for chronic back pain in adults: a systematic review and metanalysis. [2022]

2. 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]

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

Treating pain using acupuncture for nonacupuncturists. [2023]

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

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

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

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

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

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