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Accessible Acupuncture for the Warrior With Acute Low Back Pain

Primary Purpose

Acupuncture, Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NSAIDS
Battlefield Acupuncture
GV26 with manual tonification
Sponsored by
David Moss
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture focused on measuring acupuncture, low back pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

**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

Sites / Locations

  • Mike O'Callaghan Military Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1 (NSAIDS only)

Group 2 (Acupuncture+GV26)

Group 3 (Battlefield Acupuncture+NSAIDS)

Group 4 (Battlefield Acupuncture+GV26+NSAIDS)

Arm Description

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

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)

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)

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2020
Last Updated
January 26, 2023
Sponsor
David Moss
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1. Study Identification

Unique Protocol Identification Number
NCT04236908
Brief Title
Accessible Acupuncture for the Warrior With Acute Low Back Pain
Official Title
Accessible Acupuncture for the Warrior With Acute Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Moss

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Low Back Pain
Keywords
acupuncture, low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (NSAIDS only)
Arm Type
Experimental
Arm Description
NSAIDs only (naproxen 500mg by mouth twice a day as needed)
Arm Title
Group 2 (Acupuncture+GV26)
Arm Type
Experimental
Arm Description
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)
Arm Title
Group 3 (Battlefield Acupuncture+NSAIDS)
Arm Type
Experimental
Arm Description
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)
Arm Title
Group 4 (Battlefield Acupuncture+GV26+NSAIDS)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
NSAIDS
Intervention Description
Naproxen 500mg by mouth twice a day as needed.
Intervention Type
Device
Intervention Name(s)
Battlefield Acupuncture
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
GV26 with manual tonification
Intervention Description
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 Measure Information:
Title
Change in Defense and Veterans Pain Rating Scale (DVPRS)
Description
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.
Time Frame
Pre-treatment: time 0 (week 1); post-treatment (week 2 followup)
Title
Number of days missed from work due to lower back pain.
Description
The number of days missed from work is self-explanatory and will be treated as a parametric interval variable.
Time Frame
Post-treatment (Visit 2, 1 week followup)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill M Clark, MBA
Phone
7026533298
Email
jill.m.clark15.ctr@mail.mil
Facility Information:
Facility Name
Mike O'Callaghan Military Medical Center
City
Nellis Air Force Base
State/Province
Nevada
ZIP/Postal Code
89191
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda J Crawford, MSHS
Phone
702-653-3298
Email
amanda.j.crawford.ctr@mail.mil
First Name & Middle Initial & Last Name & Degree
Jill M Clark, MBA/HCM
Phone
702-653-3298
Email
jill.m.clark15.ctr@mail.mil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan on sharing data.
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Accessible Acupuncture for the Warrior With Acute Low Back Pain

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