Accessible Acupuncture for the Warrior With Acute Low Back Pain

Low Back Pain Clinical Trial

Official title:

Accessible Acupuncture for the Warrior With Acute Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04236908
• Other study ID #: FWH20200025H
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Mike O'Callaghan Military Hospital
• Contact: Jill M Clark, MBA
• Phone: 7026533298
• Email: jill.m.clark15.ctr[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

**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

Related Conditions & MeSH terms

• Acupuncture
• Back Pain
• Low Back Pain

Intervention

Drug:
• NSAIDS
Naproxen 500mg by mouth twice a day as needed.

Device:
• Battlefield Acupuncture
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
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.

Locations

Country	Name	City	State
United States	Mike O'Callaghan Military Medical Center	Nellis Air Force Base	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
David Moss

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Niemtzow RC. Battlefield Acupuncture. Med Acupunct. 2007;19(4):225-228

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)