AcupunctureNCT04236908

Accessible Acupuncture for the Warrior With Acute Low Back Pain

A study testing NSAIDS, Battlefield Acupuncture and GV26 with manual tonification in people with Acupuncture and Low Back Pain, run by David Moss at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acupuncture, Low Back Pain
What is being tested?: NSAIDS, Battlefield Acupuncture and GV26 with manual tonification
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 276 participants
Where: 1 siteUnited States
Study dates: 25 Aug 2020to 9 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, 89191

Other trials in United States

About this study

Read the 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).

Conditions: Acupuncture, Low Back Pain
Being tested: NSAIDS, Battlefield Acupuncture, GV26 with manual tonification
Keywords: acupuncture, low back pain
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NSAIDSDrug
Naproxen 500mg by mouth twice a day as needed.
Battlefield AcupunctureDevice
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 tonificationDevice
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.

Study groups in NCT04236908
Study group	Role	What they receive
Group 1 (NSAIDS only)	Experimental	NSAIDs only (naproxen 500mg by mouth twice a day as needed) Receives: 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) Receives: 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) Receives: 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). Receives: Drug: NSAIDS; Device: Battlefield Acupuncture; Device: GV26 with manual tonification

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Post-treatment (Visit 2, 1 week followup)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Aug 20209 Dec 2025

First posted22 Jan 2020
Study start25 Aug 2020
Primary completion9 Dec 2025
Study completion9 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for AcupunctureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04236908
Sponsor's protocol ID: FWH20200025H
Status last verified: Dec 2025
First submitted: 17 Jan 2020
Last updated: 16 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: We do not plan on sharing data.

Publications

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.
PubMed 27152681
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.
PubMed 28488875
Clark LL, Hu Z. Diagnoses of low back pain, active component, U.S. Armed Forces, 2010-2014. MSMR. 2015 Dec;22(12):8-11.
PubMed 26726722
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.
PubMed 23819534
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.
PubMed 19901146
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.
PubMed 20117593
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.
PubMed 26346626
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.
PubMed 23992937
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.
PubMed 9383501
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.
PubMed 21366079
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.
PubMed 22360055
Holm, S. 1979. A simple sequential rejective multiple test procedure. Scand. J. Statistics, 6: 65-70.
R Core Team. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 2016
Niemtzow RC. Battlefield Acupuncture. Med Acupunct. 2007;19(4):225-228

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Acupuncture trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Accessible Acupuncture for the Warrior With Acute Low Back Pain
ClinicalTrials.gov ID: NCT04236908
Acronym / sponsor ID: FWH20200025H
Conditions: Acupuncture, Low Back Pain
Keywords: acupuncture, low back pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: David MossUS federal agency
Study start: 25 Aug 2020 (actual)
Primary completion: 9 Dec 2025 (actual)
Study completion: 9 Dec 2025 (actual)
First posted: 22 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1 (NSAIDS only)	Experimental	Drug: NSAIDSNSAIDs only (naproxen 500mg by mouth twice a day as needed)
Group 2 (Acupuncture+GV26)	Experimental	Drug: NSAIDS, Device: GV26 with manual tonificationAcupuncture 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)
Group 3 (Battlefield Acupuncture+NSAIDS)	Experimental	Drug: NSAIDS, Device: Battlefield AcupunctureBattlefield 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)
Group 4 (Battlefield Acupuncture+GV26+NSAIDS)	Experimental	Drug: NSAIDS, Device: Battlefield Acupuncture, Device: GV26 with manual tonificationGV26 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NSAIDSNaproxen 500mg by mouth twice a day as needed.	Drug	Group 1 (NSAIDS only), Group 2 (Acupuncture+GV26), Group 3 (Battlefield Acupuncture+NSAIDS), Group 4 (Battlefield Acupuncture+GV26+NSAIDS)
Battlefield AcupunctureBattlefield 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.	Device	Group 3 (Battlefield Acupuncture+NSAIDS), Group 4 (Battlefield Acupuncture+GV26+NSAIDS)
GV26 with manual tonificationAcupuncture 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.	Device	Group 2 (Acupuncture+GV26), Group 4 (Battlefield Acupuncture+GV26+NSAIDS)

Primary outcome

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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Background: PubMed 27152681Armed 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.
Background: PubMed 28488875Armed 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.
Background: PubMed 26726722Clark LL, Hu Z. Diagnoses of low back pain, active component, U.S. Armed Forces, 2010-2014. MSMR. 2015 Dec;22(12):8-11.
Background: PubMed 23819534Armed 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.
Background: PubMed 19901146Cohen 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.
Background: PubMed 20117593Ruscio 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.
Background: PubMed 26346626Liu 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.
Background: PubMed 23992937Knox 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.
Background: PubMed 9383501Simon-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.
Background: PubMed 21366079Niebuhr 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.
Background: PubMed 22360055Sikorski 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.
BackgroundHolm, S. 1979. A simple sequential rejective multiple test procedure. Scand. J. Statistics, 6: 65-70.
Individual participant dataSharing planned: No. We do not plan on sharing data.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NSAIDS, Battlefield Acupuncture and GV26 with manual tonification in people with Acupuncture and Low Back Pain, run by David Moss at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Defense and Veterans Pain Rating Scale (DVPRS) (time frame: Pre-treatment: time 0 (week 1); post-treatment (week 2 followup)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04236908, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.