search
Back to results

Battlefield Acupuncture for Low Back Pain (BFA)

Primary Purpose

Low Back Pain, Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular Acupuncture
Sham Treatment
Sponsored by
The Geneva Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Malcolm Grow Medical Clinics and Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham Treatment

Auricular Acupuncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in pain medication need.
A self reported increase, decrease, or no change in medication use.
Change in trunk flexion.
Trunk flexion will be assessed with Dual Digital Inclinometers. The Dual Digital Inclinometer is placed around the sacrum and measures the angle of flexion.
Change in balance
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.
Change in physical activity
Activity will be measured using an Actigraph watch and Modified Oswestry Low Back Pain Disability Questionnairre(mODI)
Change in sleep quality
Sleep will be measured using an Actigraph watch, Epworth Sleepiness Scale(ESS), and Insomnia Severity Index(ISI)

Full Information

First Posted
March 23, 2018
Last Updated
July 28, 2021
Sponsor
The Geneva Foundation
Collaborators
TriService Nursing Research Program
search

1. Study Identification

Unique Protocol Identification Number
NCT03491124
Brief Title
Battlefield Acupuncture for Low Back Pain
Acronym
BFA
Official Title
Battlefield Acupuncture for Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Geneva Foundation
Collaborators
TriService Nursing Research Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham Treatment
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Auricular Acupuncture
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Auricular Acupuncture
Other Intervention Name(s)
Battlefield Acupuncture (BFA)
Intervention Description
Up to five small ASP needles placed in each ear until pain is reduced to 1/10.
Intervention Type
Other
Intervention Name(s)
Sham Treatment
Intervention Description
Laser pointer pointed at the ear, but not turned on.
Primary Outcome Measure Information:
Title
Pain level change over time on the Defense/Veterans Pain Rating Scale(DVPRS).
Description
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).
Time Frame
The DVPRS will be administered weekly for seven times. Followed by a one time washout 2 weeks later.
Secondary Outcome Measure Information:
Title
Change in pain medication need.
Description
A self reported increase, decrease, or no change in medication use.
Time Frame
A medication form will be administered weekly for seven times. Followed by a one time washout 2 weeks later.
Title
Change in trunk flexion.
Description
Trunk flexion will be assessed with Dual Digital Inclinometers. The Dual Digital Inclinometer is placed around the sacrum and measures the angle of 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.
Title
Change in balance
Description
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.
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.
Title
Change in physical activity
Description
Activity will be measured using an Actigraph watch and Modified Oswestry Low Back Pain Disability Questionnairre(mODI)
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.
Title
Change in sleep quality
Description
Sleep will be measured using an Actigraph watch, Epworth Sleepiness Scale(ESS), and Insomnia Severity Index(ISI)
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.
Other Pre-specified Outcome Measures:
Title
Health and well being
Description
Health and well being is measured using the SF-8 Health Survey (4 Week Recall).
Time Frame
The SF-8 is administered the first, fourth, and eighth week.
Title
Height, weight, and Body Mass Index(BMI)
Description
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.
Time Frame
Height, weight, and BMI is measured the first and eighth week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candy Wilson, PhD
Organizational Affiliation
Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malcolm Grow Medical Clinics and Surgery Center
City
Andrews Air Force Base
State/Province
Maryland
ZIP/Postal Code
20762
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Battlefield Acupuncture for Low Back Pain

We'll reach out to this number within 24 hrs