Accessible Acupuncture for the Warrior With Acute Low Back Pain

NCT04236908 | Completed FDA Device

• 1 other identifier: FWH20200025H
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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).

Conditions

Acupuncture; Low Back Pain

Keywords

acupuncture; low back pain

Outcome Measures

Primary Outcomes (2)

• Change in Defense and Veterans Pain Rating Scale (DVPRS)

  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.

  Pre-treatment: time 0 (week 1); post-treatment (week 2 followup)

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

  The number of days missed from work is self-explanatory and will be treated as a parametric interval variable.

  Post-treatment (Visit 2, 1 week followup)

Study Arms (4)

Group 1 (NSAIDS only)

EXPERIMENTAL

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

Drug: NSAIDS

Group 2 (Acupuncture+GV26)

EXPERIMENTAL

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)

Drug: NSAIDS; Device: GV26 with manual tonification

Group 3 (Battlefield Acupuncture+NSAIDS)

EXPERIMENTAL

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)

Drug: NSAIDS; Device: Battlefield Acupuncture

Group 4 (Battlefield Acupuncture+GV26+NSAIDS)

EXPERIMENTAL

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).

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

Interventions

NSAIDS DRUG

Naproxen 500mg by mouth twice a day as needed.

Group 1 (NSAIDS only); Group 2 (Acupuncture+GV26); Group 3 (Battlefield Acupuncture+NSAIDS); Group 4 (Battlefield Acupuncture+GV26+NSAIDS)

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.

Group 3 (Battlefield Acupuncture+NSAIDS); Group 4 (Battlefield Acupuncture+GV26+NSAIDS)

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.

Group 2 (Acupuncture+GV26); Group 4 (Battlefield Acupuncture+GV26+NSAIDS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Moss: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (14)

• Armed Forces Health Surveillance Branch. Absolute and relative morbidity burdens attributable to various illnesses and injuries, active component, U.S. Armed Forces, 2015. MSMR. 2016 Apr;23(4):2-7. No abstract available.

  PMID: 27152681 BACKGROUND

• Armed Forces Health Surveillance Branch. Absolute and relative morbidity burdens attributable to various illnesses and injuries, active component, U.S. Armed Forces, 2016. MSMR. 2017 Apr;24(4):2-8. No abstract available.

  PMID: 28488875 BACKGROUND

• Clark LL, Hu Z. Diagnoses of low back pain, active component, U.S. Armed Forces, 2010-2014. MSMR. 2015 Dec;22(12):8-11.

  PMID: 26726722 BACKGROUND

• Armed Forces Health Surveillance Center (AFHSC). Medical evacuations from Afghanistan during Operation Enduring Freedom, active and reserve components, U.S. Armed Forces, 7 October 2001-31 December 2012. MSMR. 2013 Jun;20(6):2-8.

  PMID: 23819534 BACKGROUND

• Cohen SP, Nguyen C, Kapoor SG, Anderson-Barnes VC, Foster L, Shields C, McLean B, Wichman T, Plunkett A. Back pain during war: an analysis of factors affecting outcome. Arch Intern Med. 2009 Nov 9;169(20):1916-23. doi: 10.1001/archinternmed.2009.380.

  PMID: 19901146 BACKGROUND

• Ruscio BA, Jones BH, Bullock SH, Burnham BR, Canham-Chervak M, Rennix CP, Wells TS, Smith JW. A process to identify military injury prevention priorities based on injury type and limited duty days. Am J Prev Med. 2010 Jan;38(1 Suppl):S19-33. doi: 10.1016/j.amepre.2009.10.004.

  PMID: 20117593 BACKGROUND

• Liu YT, Chiu CW, Chang CF, Lee TC, Chen CY, Chang SC, Lee CY, Lo LC. Efficacy and Safety of Acupuncture for Acute Low Back Pain in Emergency Department: A Pilot Cohort Study. Evid Based Complement Alternat Med. 2015;2015:179731. doi: 10.1155/2015/179731. Epub 2015 Aug 4.

  PMID: 26346626 BACKGROUND

• Knox JB, Orchowski JR, Scher DL, Owens BD, Burks R, Belmont PJ Jr. Occupational driving as a risk factor for low back pain in active-duty military service members. Spine J. 2014 Apr;14(4):592-7. doi: 10.1016/j.spinee.2013.06.029. Epub 2013 Aug 27.

  PMID: 23992937 BACKGROUND

• Simon-Arndt CM, Yuan H, Hourani LL. Aircraft type and diagnosed back disorders in U.S. Navy pilots and aircrew. Aviat Space Environ Med. 1997 Nov;68(11):1012-8.

  PMID: 9383501 BACKGROUND

• Niebuhr DW, Krampf RL, Mayo JA, Blandford CD, Levin LI, Cowan DN. Risk factors for disability retirement among healthy adults joining the U.S. Army. Mil Med. 2011 Feb;176(2):170-5. doi: 10.7205/milmed-d-10-00114.

  PMID: 21366079 BACKGROUND

• Sikorski C, Emerson MA, Cowan DN, Niebuhr DW. Risk factors for medical disability in U.S. enlisted Marines: fiscal years 2001 to 2009. Mil Med. 2012 Feb;177(2):128-34. doi: 10.7205/milmed-d-11-00250.

  PMID: 22360055 BACKGROUND

• Holm, S. 1979. A simple sequential rejective multiple test procedure. Scand. J. Statistics, 6: 65-70.

  BACKGROUND

• R Core Team. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 2016

  BACKGROUND

• Niemtzow RC. Battlefield Acupuncture: My Story. Med Acupunct. 2018 Apr 1;30(2):57-58. doi: 10.1089/acu.2018.29077.rcn. No abstract available.

  PMID: 29937955 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 22, 2020
• Study Start: August 25, 2020
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)