Accessible Acupuncture for the Warrior With Acute Low Back Pain

Not Applicable

Recruiting

• Conditions: Acupuncture; Low Back Pain
• Interventions: Drug: NSAIDS; Device: Battlefield Acupuncture; Device: GV26 with manual tonification

• Registration Number: NCT04236908
• Lead Sponsor: David Moss

Brief Summary

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).

Detailed Description

The study will be a randomized control trial of Active Duty and DoD Beneficiaries aged 18 years or older with complaints of acute lower back pain (four weeks or less in duration). Subjects will be randomized into one of four study groups receiving either 1) NSAIDs only (naproxen 500mg by mouth twice a day as needed) or 2) 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) or 3) 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) or 4) 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). We seek to determine if acupuncture is superior to conservative management alone in treating acute low back pain (4 weeks or less in duration).

Study Timeline

• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-21
• Study First Posted: 2020-01-22
• Study Start: 2020-08-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• Male and Female Active Duty and DoD Beneficiaries aged 18 years or older.
• Complaints of acute back pain (4 weeks or less in duration).

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Exclusion Criteria

• Known history of underlying rheumatologic condition.
• Chronic low back pain (greater than 4 weeks in duration).
• Contraindications to NSAID use (including peptic ulcer disease, underlying coagulopathy, severe coronary artery disease, underlying renal disease, allergy, thrombocytopenia).
• Red flag symptoms of low back pain (to include bowel or bladder incontinence, sudden onset sensorineural deficits, loss of sensation in the perineal region).
• Requiring narcotic use to control symptoms.
• Patients currently taking opioid medications.
• pregnant, may be pregnant, or attempting to become pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 (Acupuncture+GV26)	NSAIDS	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 3 (Battlefield Acupuncture+NSAIDS)	NSAIDS	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 1 (NSAIDS only)	NSAIDS	NSAIDs only (naproxen 500mg by mouth twice a day as needed)
Group 4 (Battlefield Acupuncture+GV26+NSAIDS)	NSAIDS	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 4 (Battlefield Acupuncture+GV26+NSAIDS)	Battlefield Acupuncture	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 2 (Acupuncture+GV26)	GV26 with manual tonification	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 3 (Battlefield Acupuncture+NSAIDS)	Battlefield Acupuncture	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 4 (Battlefield Acupuncture+GV26+NSAIDS)	GV26 with manual tonification	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).

Primary Outcome Measures

Name	Time	Method
Change in Defense and Veterans Pain Rating Scale (DVPRS)	Pre-treatment: time 0 (week 1); post-treatment (week 2 followup)	The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used.
Number of days missed from work due to lower back pain.	Post-treatment (Visit 2, 1 week followup)	The number of days missed from work is self-explanatory and will be treated as a parametric interval variable.

Trial Locations

Locations (1)

Mike O'Callaghan Military Medical Center; 🇺🇸 Nellis Air Force Base, Nevada, United States