Acupuncture for Lower Back Pain

Overseen By Jill M Clark, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: laurie wallace

Must not be taking: Opioids, Narcotics

Disqualifiers: Rheumatologic conditions, Chronic pain, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

276 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to determine if auricular acupuncture and/or the acupuncture point governor vessel 26 (GV26) with manual tonification is superior to conservative management (NSAIDs) at reducing acute low back pain (less than 4 weeks in duration).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who require narcotics or are currently taking opioids.

What data supports the effectiveness of the treatment Battlefield Acupuncture, Auricular Therapy, Ear Acupuncture, Auriculotherapy, Battlefield Acupuncture Protocol, BFA, GV26 with manual tonification, NSAIDS for lower back pain?

Research shows that auricular acupuncture, including Battlefield Acupuncture, can effectively reduce pain intensity and improve daily activities in people with chronic back pain. Studies have demonstrated that auricular acupuncture provides immediate pain relief and improves psychological well-being, activity levels, and sleep quality. ^{1 2 3 4 5}

Is acupuncture safe for treating lower back pain?

Acupuncture, including Battlefield Acupuncture and other forms of auricular therapy, is generally considered safe for treating pain. Most reported side effects are mild and temporary, such as tenderness, dizziness, or minor bleeding at the needle site. ^{3 6 7 8 9}

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

Battlefield Acupuncture is unique because it is a specific ear acupuncture technique that can be quickly administered by non-specialists, providing immediate pain relief with minimal risk and side effects, making it a practical alternative or complement to traditional pain management methods. ^{3 4 7 9 10}

Eligibility Criteria

This trial is for active duty military and DoD beneficiaries at Nellis Air Force Base, aged 18 or older, who are experiencing acute low back pain lasting less than 4 weeks. It's not suitable for those with chronic back pain, rheumatologic conditions, severe symptoms like loss of sensation in the groin area or incontinence, pregnant women, individuals needing narcotics for pain relief, or people who can't take NSAIDs due to medical reasons.

Inclusion Criteria

I have been experiencing back pain for 4 weeks or less.

Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study

I am over 18 and either active duty or a DoD beneficiary.

Exclusion Criteria

I am currently taking opioid medications.

I experience severe lower back pain with symptoms like loss of bladder control or numbness in the groin area.

I need narcotics to manage my symptoms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either NSAIDs only, acupuncture with GV26, Battlefield Acupuncture, or a combination of acupuncture treatments plus NSAIDs

4 weeks

Weekly visits for treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

2 visits (in-person)

Treatment Details

Interventions

• Battlefield Acupuncture
• GV26 with manual tonification
• NSAIDS

Trial Overview The study aims to see if auricular acupuncture (Battlefield Acupuncture) and GV26 acupuncture with manual tonification are more effective than standard treatment with NSAIDs at reducing short-term lower back pain.

Participant Groups

Group I: Group 4 (Battlefield Acupuncture+GV26+NSAIDS) Experimental Treatment 3 Interventions

GV26 with manual tonification + Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men) plus NSAIDs (naproxen 500mg by mouth twice a day as needed).

Group II: Group 3 (Battlefield Acupuncture+NSAIDS) Experimental Treatment 2 Interventions

Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men) plus NSAIDs (naproxen 500mg by mouth twice a day as needed)

Group III: Group 2 (Acupuncture+GV26) Experimental Treatment 2 Interventions

Acupuncture to include use of GV 26 with manual tonification (twisting or rotating the needle) plus NSAIDs (naproxen 500mg by mouth twice a day as needed)

Group IV: Group 1 (NSAIDS only) Experimental Treatment 1 Intervention

NSAIDs only (naproxen 500mg by mouth twice a day as needed)

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?

laurie wallace

Lead Sponsor

Trials

1

Recruited

280+

David Moss

Lead Sponsor

Trials

6

Recruited

830+

Findings from Research

Auricular acupuncture significantly reduced pain intensity and its impact on daily activities in individuals with back musculoskeletal disorders, as shown in a randomized clinical trial with 110 participants.

Both the treatment and placebo groups experienced decreased pain intensity, but the treatment group showed a greater reduction in the impact of pain on daily activities, indicating that auricular acupuncture can be an effective intervention for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of auricular acupuncture on chronic pain in people with back musculoskeletal disorders: a randomized clinical trial. Moura, CC., Chaves, ECL., Chianca, TCM., et al.[2019]

Auricular electroacupuncture (EA) significantly relieves chronic low back pain more effectively than conventional manual acupuncture, as shown in a study with 61 patients over 6 weeks, leading to better pain relief and improved psychological well-being.

Patients receiving EA also reported less need for analgesic medication and had better activity levels and sleep quality, with no adverse side effects noted, indicating it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The short- and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricular acupuncture. Sator-Katzenschlager, SM., Scharbert, G., Kozek-Langenecker, SA., et al.[2019]

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]

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]

Auricular acupuncture treatments led to an impressive average pain score reduction of nearly 60% among patients, indicating significant efficacy in pain management.

The positive effects of the treatment lasted between 1 to 3 months for 47% of patients, and 83.6% reported the treatment as helpful, suggesting a strong perceived benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case series of auricular acupuncture in a veteran's population using a revised auricular mapping-diagnostic paradigm (RAMP-uP). Huang, W., Halpin, SN., Perkins, MM.[2017]

A systematic review of various studies found that adverse events from auricular therapy (AT) are generally mild and transient, with common issues including tenderness, dizziness, and local discomfort, but no serious adverse events were reported.

The study highlights the need for improved reporting of adverse events in future AT research, suggesting that while AT appears to be a safe treatment option, more comprehensive data collection is necessary to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of auricular therapy: a systematic review. Tan, JY., Molassiotis, A., Wang, T., 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]

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]

Auricular acupuncture and extended auricular therapy can effectively help with pain and anxiety, but using embedded needles poses significant safety risks, including infections and chondritis, as highlighted by 19 adverse event case reports and multiple safety reviews.

Extended auricular therapy using non-invasive methods, like applying natural seeds, offers similar clinical benefits without the risks associated with embedded needles, suggesting a need for further research to determine the necessity of needle use in auricular treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. Nielsen, A., Gereau, S., Tick, H.[2021]

References

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

Effects of auricular acupuncture on chronic pain in people with back musculoskeletal disorders: a randomized clinical trial. [2019]

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

The short- and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricular acupuncture. [2019]

3. 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]

4. Brazil pubmed.ncbi.nlm.nih.gov

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

5. Scotland pubmed.ncbi.nlm.nih.gov

A case series of auricular acupuncture in a veteran's population using a revised auricular mapping-diagnostic paradigm (RAMP-uP). [2017]

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

Adverse events of auricular therapy: a systematic review. [2022]

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

Treating pain using acupuncture for nonacupuncturists. [2023]

8. Singapore pubmed.ncbi.nlm.nih.gov

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

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

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

10. England pubmed.ncbi.nlm.nih.gov

Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. [2021]