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Accessible Acupuncture for the Warrior With Acute Low Back Pain

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ClinicalTrials.gov Identifier: NCT04236908
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : June 23, 2021
Sponsor:
Information provided by (Responsible Party):
laurie wallace, Mike O'Callaghan Military Hospital

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).

Condition or disease Intervention/treatment Phase
Acupuncture Low Back Pain Drug: NSAIDS Device: Battlefield Acupuncture Device: GV26 with manual tonification Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accessible Acupuncture for the Warrior With Acute Low Back Pain
Actual Study Start Date : August 25, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 (NSAIDS only)
NSAIDs only (naproxen 500mg by mouth twice a day as needed)
Drug: NSAIDS
Naproxen 500mg by mouth twice a day as needed.

Experimental: Group 2 (Acupuncture+GV26)
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
Naproxen 500mg by mouth twice a day as needed.

Device: 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.


Experimental: Group 3 (Battlefield Acupuncture+NSAIDS)
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
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.


Experimental: Group 4 (Battlefield Acupuncture+GV26+NSAIDS)
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
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.


Device: 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.





Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

**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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236908


Contacts
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Contact: Jill M Clark, MBA 7026533298 jill.m.clark15.ctr@mail.mil

Locations
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United States, Nevada
Mike O'Callaghan Military Medical Center Recruiting
Nellis Air Force Base, Nevada, United States, 89191
Contact: Amanda J Crawford, MSHS    702-653-3298    amanda.j.crawford.ctr@mail.mil   
Contact: Jill M Clark, MBA/HCM    702-653-3298    jill.m.clark15.ctr@mail.mil   
Sponsors and Collaborators
laurie wallace
Publications:
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

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Responsible Party: laurie wallace, Principal Investigator, Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT04236908    
Other Study ID Numbers: FWH20200025H
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan on sharing data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by laurie wallace, Mike O'Callaghan Military Hospital:
acupuncture
low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations