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Completed

NCT Number: NCT04236908

Accessible Acupuncture for the Warrior With Acute Low Back Pain

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).

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Key information

Conditions

Acupuncture Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

**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

Treatment and study plan

NSAIDs

Drug

Naproxen 500mg by mouth twice a day as needed.

Battlefield Acupuncture

Device

Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men).

Battlefield acupuncture utilizes up to 10 ASP acupuncture needles (5 in each ear). The Battlefield Acupuncture points include: cingulate gyrus, thalamus, omega-2, point zero, and shen men. The semi-permanent needles are left in place and typically stay in place for 2-7 days. Needles will usually fall out on their own, can be removed by the patient or the patient can call study staff and come in for removal if desired.

GV26 with manual tonification

Device

Acupuncture to include use of GV 26 with manual tonification (twisting or rotating the needle).

The protocol for using GV26 is as follows: With the patient in a seated position the acupuncturist places a 40mm needle in the acupuncture point GV26 (located on the philtrum, on the anterior midline, at the junction of the upper 1/3 and lower 2/3 of the distance from the nose to the margin of the upper lip). The acupuncturist then rapidly rotates the needle at the handle clockwise and counterclockwise (known as manual tonification) for 20-40 seconds at a time. The patient then stands up and assesses their pain. This will be performed up to 6 cycles. If a patient is unable to sit or stand, this may also be performed in a supine position with the patient attempting to sit or stand every 20-40 seconds.

Primary outcomes

  1. Change in Defense and Veterans Pain Rating Scale (DVPRS)

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

David Moss

Fed

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2020
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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