Battlefield Acupuncture for Low Back Pain

NCT03491124 | Completed

• 1 other identifier: N16-006
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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. 1.To explore the effects of BFA two weeks following the treatment for LBP.
2. 2.Do positive outcomes appreciated with BFA persist over two weeks?
3. 3.What is the pain medication usage during and after intervention treatments?
4. 4.To explore the effectiveness of BFA on trunk flexion mobility and balance.
5. 5.Does pain reduction improve trunk flexion and balance?
6. 6.Does improved truck flexion mobility and balance contribute to increased physical activity?

Conditions

Low Back Pain; Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Pain level change over time on the Defense/Veterans Pain Rating Scale(DVPRS).

  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).

  The DVPRS will be administered weekly for seven times. Followed by a one time washout 2 weeks later.

Secondary Outcomes (5)

• Change in pain medication need.

  A medication form will be administered weekly for seven times. Followed by a one time washout 2 weeks later.

• Change in trunk flexion.

  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.

• Change in balance

  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.

• Change in physical activity

  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.

• Change in sleep quality

  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.

Other Outcomes (2)

• Health and well being

  The SF-8 is administered the first, fourth, and eighth week.

• Height, weight, and Body Mass Index(BMI)

  Height, weight, and BMI is measured the first and eighth week.

Study Arms (2)

Sham Treatment

SHAM COMPARATOR

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

Auricular Acupuncture

EXPERIMENTAL

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

Interventions

Auricular Acupuncture OTHER

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

Also known as: Battlefield Acupuncture (BFA)

Auricular Acupuncture

Sham Treatment OTHER

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

Sham Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Geneva Foundation: lead
• TriService Nursing Research Program: collaborator

Study Sites (1)

Malcolm Grow Medical Clinics and Surgery Center

Andrews Air Force Base, Maryland, 20762, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Candy Wilson, PhD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 9, 2018
• Study Start: March 23, 2018
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

US (1)