Clinical trial NCT04236908: Accessible Acupuncture for the Warrior With Acute Low Back Pain
Official title: Accessible Acupuncture for the Warrior With Acute Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acupuncture
Low Back Pain
Keywords: acupuncture
low back pain
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2020-01-22
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Change in Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: Pre-treatment: time 0 (week 1); post-treatment (week 2 followup)
measure: Number of days missed from work due to lower back pain.
timeFrame: Post-treatment (Visit 2, 1 week followup)
Secondary outcomes:
Other outcomes:
Locations:
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Military Medical Center
state: Nevada
Study officials:
References:
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