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Accessible Acupuncture for the Warrior With Acute Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236908
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : July 1, 2020
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 standard of care conservative management at reducing acute low back pain (5 days or less in duration).

Condition or disease Intervention/treatment Phase
Acupuncture Low Back Pain Device: Acupuncture Other: Standard of care 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 (5 days or less in duration).

Subjects will be randomized into one of two study groups receiving either 1) standard of care conservative management or 2) acupuncture -- to include use of auricular points (which may include hypothalamus, hippocampus, amygdala, master cerebral, shen men, point zero, cingulate gyrus, thalamus, omega 2, and lumbar) and GV26 with manual tonification (twiddling the needle until the patient feels better, approximately 1-5 minutes) (as needed) -- plus conservative management. The investigators seek to determine if acupuncture plus conservative management is superior to conservative management alone in treating acute low back pain (5 days or less in duration).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Standard of care conservative management.
Other: Standard of care
Standard of care conservative management

Experimental: Intervention
Acupuncture to include use of auricular points and GV26 (acupuncture point just below the nose) with manual tonification (twiddling the needle until the patient feels better, approximately 1-5 minutes) (as needed) plus standard of care conservative management.
Device: Acupuncture
Acupuncture to include use of auricular points and GV26 (acupuncture point just below the nose) with manual tonification (twiddling the needle until the patient feels better, approximately 1-5 minutes) (as needed) plus standard of care conservative management

Other: Standard of care
Standard of care conservative management




Primary Outcome Measures :
  1. Change in Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: Pre-treatment: time 0, visit 1 (week 1); post-treatment: time 0, visit 1 (week 1); post-treatment, visit 2 (1 week follow-up) ]
    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 follow-up) ]
    The number of days missed from work is self-explanatory and will be treated as an 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 (5 days or less in duration).

Exclusion Criteria:

  • Known history of underlying rheumatologic condition.
  • Chronic low back pain (greater than 5 days 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.

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

Sponsors and Collaborators
laurie wallace
Investigators
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Study Director: Paul F Crawford, MD United States Air Force
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

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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: July 1, 2020
Last Verified: June 2020
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
Signs and Symptoms