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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acupuncture, specifically auricular (ear) acupuncture and GV26 (a point on the upper lip), can better relieve recent lower back pain compared to using only NSAIDs like naproxen. Participants will divide into groups to receive different combinations of acupuncture and NSAIDs to determine which combination provides the most relief. Ideal participants are active duty military or Department of Defense beneficiaries who have experienced acute back pain for less than four weeks and can receive care at Nellis Air Force Base.

As an unphased trial, this study offers participants the opportunity to explore alternative pain relief methods beyond standard medication.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Battlefield Acupuncture effectively and safely manages sudden pain. One study found that 82% of patients experienced less pain after treatment. This method has also been used successfully for various types of pain, such as lower back pain.

Studies indicate that GV26 with manual tonification is often used for sudden conditions like lower back pain and is considered safe, with few side effects. A review of several studies found significant improvements when GV26 was combined with other acupuncture points.

Both treatments have a good safety record, with rare side effects. For instance, fainting or dizziness occurs in only 0.02% to 7% of acupuncture treatments. Overall, both Battlefield Acupuncture and GV26 are well-tolerated options for pain relief. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for lower back pain because they incorporate acupuncture techniques that offer a unique approach compared to standard care options like NSAIDs alone. Battlefield Acupuncture uses specific ear points believed to influence pain perception and reduce discomfort rapidly, which differs from traditional pain medications that focus on reducing inflammation. The inclusion of GV26 with manual tonification introduces a distinct method of enhancing acupuncture's effects by physically stimulating the needle, potentially providing a more immediate and targeted relief. These innovative methods aim to provide faster, more comprehensive pain management, potentially minimizing reliance on long-term medication use.

What evidence suggests that this trial's treatments could be effective for lower back pain?

Research shows that acupuncture, including a technique where the needle is twisted or rotated at a specific point called GV26, can help relieve pain. In this trial, some participants will receive GV26 acupuncture along with NSAIDs. Studies have found that using GV26 with other acupuncture points leads to significant improvements. Acupuncture is a popular choice for managing lower back pain because it usually has fewer side effects than medications.

In Battlefield Acupuncture, another treatment arm in this trial, research indicates that more than three-quarters of people experience immediate pain relief after treatment, and over half report significant relief. This method effectively reduces pain quickly, especially for veterans with lower back pain. Overall, both GV26 acupuncture and Battlefield Acupuncture show promise in managing sudden lower back pain. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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 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]

Citations

1. 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 ...

2. 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 ...

3. 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 ...

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29550099/

Battlefield acupuncture to treat low back pain in the ... Furthermore, our data suggest that BFA may be efficacious to improve LBP symptoms, and thus further efficacy studies are warranted.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02399969

Battlefield Acupuncture for the Treatment of Low Back Pain ... The hypothesis of this study is that battlefield acupuncture may improve mobility and pain of patients with low back pain in the emergency department.

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

Battlefield acupuncture to treat low back pain in the ... This is a pilot feasibility study of BFA as a treatment for acute low back pain (LBP) in the emergency department (ED).

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

Battlefield acupuncture The investigators found a decrease in pain in 82% of patients, on average, including patients seen in group settings and those seen in ...

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

Battlefield acupuncture for chronic musculoskeletal pain in ... The parent trial found that a 10-week treatment course of BFA or electroacupuncture produced significantly greater and durable pain reduction over 24 weeks ...