ClinicalTrials.gov
ClinicalTrials.gov Menu

Battlefield Acupuncture for Low Back Pain (BFA)

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: NCT03491124
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
TriService Nursing Research Program
Information provided by (Responsible Party):
David Wilson, The Geneva Foundation

Brief Summary:

The purpose of this study is to determine the effect of Battlefield Acupuncture (BFA) on outcomes for pain, sleep, and physical activity level in an active duty military sample with subacute or chronic lower back pain (LBP). BFA is a form of auricular acupuncture (AA) that has been implemented in many Department of Defense (DoD)/Veterans Affairs (VA) medical settings to alleviate acute or chronic pain. BFA uses five predetermined locations in a defined sequence to place semi-permanent needles in the ear. Subacute lower back pain is pain that has persistently lasted from four to twelve weeks. Chronic lower back pain is pain that lasts more than 12 weeks.

Hypothesis 1: Participants with subacute or chronic LBP will have reduced pain using BFA as compared to placebo.

Hypothesis 2: Participants with subacute or chronic LBP will have improved physical activity using BFA as compared to placebo.

Hypothesis 3: Participants with subacute or chronic LBP will have improved sleep quality as compared to placebo.

The secondary study aims are:

  1. To explore the effects of BFA two weeks following the treatment for LBP.

    1. Do positive outcomes appreciated with BFA persist over two weeks?
    2. What is the pain medication usage during and after intervention treatments?
  2. To explore the effectiveness of BFA on trunk flexion mobility and balance.

    1. Does pain reduction improve trunk flexion and balance?
    2. Does improved truck flexion mobility and balance contribute to increased physical activity?

Condition or disease Intervention/treatment Phase
Low Back Pain Chronic Low Back Pain Other: Auricular Acupuncture Other: Sham Treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Battlefield Acupuncture for Low Back Pain
Actual Study Start Date : March 23, 2018
Estimated Primary Completion Date : November 9, 2020
Estimated Study Completion Date : November 9, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Sham Treatment
Participants will continue to receive usual care from their primary care provider, which can include medications, physical therapy, biofeedback, and education according to DoD/VA guidelines for LBP management. Participants randomized to this arm will also receive a sham intervention, pointing a laser pointer to the ear without turning the laser on.
Other: Sham Treatment
Laser pointer pointed at the ear, but not turned on.
Experimental: Auricular Acupuncture
Participants will continue to receive usual care from their primary care provider, which can include medications, physical therapy, biofeedback, and education according to DoD/VA guidelines for LBP management. Participants randomized to this arm will receive up to five ASP needles per ear placed in the predetermined BFA pattern. Needles are placed until the participant states pain is reduced 1/10.
Other: Auricular Acupuncture
Up to five small ASP needles placed in each ear until pain is reduced to 1/10.
Other Name: Battlefield Acupuncture (BFA)



Primary Outcome Measures :
  1. Pain level change over time on the Defense/Veterans Pain Rating Scale(DVPRS). [ Time Frame: The DVPRS will be administered weekly for seven times. Followed by a one time washout 2 weeks later. ]
    Participant reported pain level using the DVPRS. DVPRS pain level ranks from 0 (no pain) to 10 (As bad as it can be. Nothing else matters).


Secondary Outcome Measures :
  1. Change in pain medication need. [ Time Frame: A medication form will be administered weekly for seven times. Followed by a one time washout 2 weeks later. ]
    A self reported increase, decrease, or no change in medication use.

  2. Change in trunk flexion. [ Time Frame: Trunk flexion will be administered weekly for seven times. Followed by a one time washout 2 weeks later. If the participant has a DVPRS >=2 and mODI >=20%, trunk flexion will also be measured after the intervention. ]
    Trunk flexion will be assessed with Dual Digital Inclinometers. The Dual Digital Inclinometer is placed around the sacrum and measures the angle of flexion.

  3. Change in balance [ Time Frame: The FRT and TUG will be administered weekly for seven times. Followed by a one time washout 2 weeks later. If the participant has a DVPRS >=2 and mODI >=20%, the FRT and TUG will also be measured after the intervention. ]
    Balance is measured by Functional Reach Test(FRT) and Timed Up and Go Test(TUG). The FRT assesses a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position. The TUG is a simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.

  4. Change in physical activity [ Time Frame: The mODI will be administered weekly for seven times. Followed by a one time washout 2 weeks later. The Actigraph watch is worn the entire 8 weeks. ]
    Activity will be measured using an Actigraph watch and Modified Oswestry Low Back Pain Disability Questionnairre(mODI)

  5. Change in sleep quality [ Time Frame: The ESS and ISI will be administered weekly for seven times. Followed by a one time washout 2 weeks later. The Actigraph watch is worn the entire 8 weeks. ]
    Sleep will be measured using an Actigraph watch, Epworth Sleepiness Scale(ESS), and Insomnia Severity Index(ISI)


Other Outcome Measures:
  1. Health and well being [ Time Frame: The SF-8 is administered the first, fourth, and eighth week. ]
    Health and well being is measured using the SF-8 Health Survey (4 Week Recall).

  2. Height, weight, and Body Mass Index(BMI) [ Time Frame: Height, weight, and BMI is measured the first and eighth week. ]
    The participants height and weight is measured. A BMI is also calculated using the following formula: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meters squared.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of LBP (pain for > 4 weeks, with or without radiating nerve pain
  • Age 18 to 50 years
  • Active duty military, Public Health Service, or Coast Guard (guard and reserve on active orders)
  • Pain score 3/10 or higher as patient reported on the DVPRS
  • mODI score ≥ 20%
  • No anticipated prolonged temporary duty, deployment, or vacation within the next month.

Exclusion Criteria:

  • Any severe comorbidity
  • LBP neurologic "red flags" indicating serious spinal pathology (i.e. bowel or bladder dysfunction)
  • Auricular acupuncture in the past 6 months
  • Use of steroids in the month prior to the study
  • Hemorrhagic disorders
  • Malignancy
  • Unexplained weight loss
  • Severe scoliosis or congenital spine disorder
  • Back pain because of a visceral problem (e.g. endometriosis)
  • Under surgeon's care for back surgery within the last 12 months
  • Balance disorder
  • Pregnancy or suspected pregnancy (last menstrual period will be reported by the patient)
  • Aversion to needles
  • Previous keloid scar formation
  • Active infection on the ear
  • Bleeding disorder
  • Metal allergy
  • Mental health diagnosis requiring medication (depression, PTSD, etc)
  • Untreated sleep apnea or other sleep disorders

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): NCT03491124


Contacts
Contact: Candy Wilson, PhD 301-295-1468 candy.wilson@usuhs.edu
Contact: David Wilson, BS 253-355-5428 militarybackpainstudy@gmail.com

Locations
United States, Maryland
Malcolm Grow Medical Clinics and Surgery Center Recruiting
Andrews Air Force Base, Maryland, United States, 20762
Contact: David Wilson, BS    253-355-5428    militarybackpainstudy@gmail.com   
Sponsors and Collaborators
The Geneva Foundation
TriService Nursing Research Program
Investigators
Principal Investigator: Candy Wilson, PhD Uniformed Services University of the Health Sciences

Responsible Party: David Wilson, Research Coordinator, The Geneva Foundation
ClinicalTrials.gov Identifier: NCT03491124     History of Changes
Other Study ID Numbers: N16-006
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms