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Behavioural Intervention

Acupuncture for Lower Back Pain

N/A

Recruiting

Research Sponsored by laurie wallace

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patients currently taking opioid medications

Red flag symptoms of low back pain (to include bowel or bladder incontinence, sudden onset sensorineural deficits, loss of sensation in the perineal region)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment (visit 2, 1 week followup)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare auricular acupuncture, GV26 acupuncture, and NSAIDs to see which is better at reducing acute low back pain.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from acupuncture may include minor bleeding or bruising at needle sites and temporary soreness. NSAID use could lead to stomach upset, heartburn, potential allergic reactions, and increased risk of ulcers or bleeding.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking opioid medications.

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

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I need narcotics to manage my symptoms.

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I have had lower back pain for more than 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment (visit 2, 1 week followup)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-treatment (visit 2, 1 week followup)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment (visit 2, 1 week followup) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Defense and Veterans Pain Rating Scale (DVPRS)

Number of days missed from work due to lower back pain.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4 (Battlefield Acupuncture+GV26+NSAIDS)Experimental Treatment3 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 Treatment2 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 Treatment2 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 Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Battlefield Acupuncture

2016

Completed Phase 2

~510

0 / 4Eligibility criteria met