Accessible Acupuncture for the Warrior With Acute Low Back Pain

David Moss

Status: Completed

Conditions: Acupuncture; Low Back Pain

Treatments: Drug: NSAIDS; Device: GV26 with manual tonification; Device: Battlefield Acupuncture

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04236908

FWH20200025H

Details and patient eligibility

About

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).

Full 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).

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

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).

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 4 patient groups

Group 1 (NSAIDS only)

Experimental group

Description:

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

Treatment:

Drug: NSAIDS

Group 2 (Acupuncture+GV26)

Experimental group

Description:

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)

Treatment:

Device: GV26 with manual tonification

Drug: NSAIDS

Group 3 (Battlefield Acupuncture+NSAIDS)

Experimental group

Description:

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)

Treatment:

Device: Battlefield Acupuncture

Drug: NSAIDS

Group 4 (Battlefield Acupuncture+GV26+NSAIDS)

Experimental group

Description:

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).

Treatment:

Device: Battlefield Acupuncture

Device: GV26 with manual tonification

Drug: NSAIDS