Accessible Acupuncture for the Warrior With Acute Low Back Pain

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    276
  • sponsor
    laurie wallace
Updated on 30 April 2022
acupuncture
conservative management
auricular acupuncture
naproxen
back pain
NSAID
low back pain
acute back pain

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).

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).

Details
Condition Acupuncture, Low Back Pain
Treatment NSAIDs, Battlefield Acupuncture, GV26 with manual tonification
Clinical Study IdentifierNCT04236908
Sponsorlaurie wallace
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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