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Accessible Acupuncture for the Warrior With Acute Low Back Pain

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Studies

Study First Submitted Date 2020-01-17
Study First Posted Date 2020-01-22
Last Update Posted Date 2023-01-27
Start Month Year August 25, 2020
Primary Completion Month Year December 2023
Verification Month Year January 2023
Verification Date 2023-01-31
Last Update Posted Date 2023-01-27

Detailed Descriptions

Sequence: 20850490
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).

Facilities

Sequence: 201276243
Status Recruiting
Name Mike O’Callaghan Military Medical Center
City Nellis Air Force Base
State Nevada
Zip 89191
Country United States

Facility Contacts

Sequence: 28280486 Sequence: 28280487
Facility Id 201276243 Facility Id 201276243
Contact Type primary Contact Type backup
Name Amanda J Crawford, MSHS Name Jill M Clark, MBA/HCM
Email [email protected] Email [email protected]
Phone 702-653-3298 Phone 702-653-3298

Conditions

Sequence: 52502721 Sequence: 52502722
Name Acupuncture Name Low Back Pain
Downcase Name acupuncture Downcase Name low back pain

Id Information

Sequence: 40395724
Id Source org_study_id
Id Value FWH20200025H

Countries

Sequence: 42832207
Name United States
Removed False

Design Groups

Sequence: 55958898 Sequence: 55958899 Sequence: 55958900 Sequence: 55958901
Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental
Title Group 1 (NSAIDS only) Title Group 2 (Acupuncture+GV26) Title Group 3 (Battlefield Acupuncture+NSAIDS) Title Group 4 (Battlefield Acupuncture+GV26+NSAIDS)
Description NSAIDs only (naproxen 500mg by mouth twice a day as needed) 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) 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) 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).

Interventions

Sequence: 52810773 Sequence: 52810774 Sequence: 52810775
Intervention Type Drug Intervention Type Device Intervention Type Device
Name NSAIDS Name Battlefield Acupuncture Name GV26 with manual tonification
Description Naproxen 500mg by mouth twice a day as needed. 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.

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.

Keywords

Sequence: 80318524 Sequence: 80318525
Name acupuncture Name low back pain
Downcase Name acupuncture Downcase Name low back pain

Design Outcomes

Sequence: 178616078 Sequence: 178616079
Outcome Type primary Outcome Type primary
Measure Change in Defense and Veterans Pain Rating Scale (DVPRS) Measure Number of days missed from work due to lower back pain.
Time Frame Pre-treatment: time 0 (week 1); post-treatment (week 2 followup) Time Frame Post-treatment (Visit 2, 1 week followup)
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. Description The number of days missed from work is self-explanatory and will be treated as a parametric interval variable.

Browse Conditions

Sequence: 194751609 Sequence: 194751610 Sequence: 194751611 Sequence: 194751612
Mesh Term Back Pain Mesh Term Low Back Pain Mesh Term Pain Mesh Term Neurologic Manifestations
Downcase Mesh Term back pain Downcase Mesh Term low back pain Downcase Mesh Term pain Downcase Mesh Term neurologic manifestations
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48626382
Agency Class FED
Lead Or Collaborator lead
Name David Moss

Central Contacts

Sequence: 12094348
Contact Type primary
Name Jill M Clark, MBA
Phone 7026533298
Email [email protected]
Role Contact

Design Group Interventions

Sequence: 68600681 Sequence: 68600682 Sequence: 68600683 Sequence: 68600684 Sequence: 68600685 Sequence: 68600686 Sequence: 68600687 Sequence: 68600688
Design Group Id 55958898 Design Group Id 55958899 Design Group Id 55958900 Design Group Id 55958901 Design Group Id 55958900 Design Group Id 55958901 Design Group Id 55958899 Design Group Id 55958901
Intervention Id 52810773 Intervention Id 52810773 Intervention Id 52810773 Intervention Id 52810773 Intervention Id 52810774 Intervention Id 52810774 Intervention Id 52810775 Intervention Id 52810775

Eligibilities

Sequence: 30954459
Gender All
Minimum Age 18 Years
Maximum Age N/A
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

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253906442
Number Of Facilities 1
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2

Designs

Sequence: 30700039
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 29066806
Responsible Party Type Sponsor-Investigator
Name David Moss
Title Principal Investigator
Affiliation Mike O’Callaghan Military Hospital

Study References

Sequence: 52409949 Sequence: 52409950 Sequence: 52409951 Sequence: 52409952 Sequence: 52409953 Sequence: 52409954 Sequence: 52409955 Sequence: 52409956 Sequence: 52409957 Sequence: 52409958 Sequence: 52409959 Sequence: 52409960 Sequence: 52409961 Sequence: 52409962
Pmid 27152681 Pmid 28488875 Pmid 26726722 Pmid 23819534 Pmid 19901146 Pmid 20117593 Pmid 26346626 Pmid 23992937 Pmid 9383501 Pmid 21366079 Pmid 22360055
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
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