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Battlefield Acupuncture for Low Back Pain

NCT03491124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-07-29

No results posted yet for this study

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

Interventions

OTHER

Auricular Acupuncture

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

OTHER

Sham Treatment

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

Sponsors & Collaborators

  • TriService Nursing Research Program

    collaborator OTHER

  • The Geneva Foundation

    lead OTHER

Principal Investigators

  • Candy Wilson, PhD · Uniformed Services University of the Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-23
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • United States

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03491124 on ClinicalTrials.gov