Battlefield Acupuncture for Low Back Pain

NCT ID: NCT03491124

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-23
• Study Completion Date: 2021-02-28

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?

Conditions

Low Back Pain; Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Sham Treatment

Intervention Type: OTHER

Laser pointer pointed at the ear, but not turned on.

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.

Group Type: EXPERIMENTAL

Auricular Acupuncture

Intervention Type: OTHER

Up to five small ASP needles placed in each ear until pain is reduced to 1/10.

Interventions

Auricular Acupuncture

Up to five small ASP needles placed in each ear until pain is reduced to 1/10.

Intervention Type: OTHER

Sham Treatment

Laser pointer pointed at the ear, but not turned on.

Intervention Type: OTHER

Other Intervention Names

Battlefield Acupuncture (BFA)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TriService Nursing Research Program

OTHER

Sponsor Role: collaborator

The Geneva Foundation

OTHER

Sponsor Role: lead

Responsible Party

David Wilson

Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Candy Wilson, PhD

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Locations

Malcolm Grow Medical Clinics and Surgery Center

Andrews Air Force Base, Maryland, United States

Countries

United States

Other Identifiers

N16-006

Identifier Type: -

Identifier Source: org_study_id