Battlefield Acupuncture for Low Back Pain (BFA)

July 28, 2021 updated by: David Wilson, The Geneva Foundation

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Andrews Air Force Base, Maryland, United States, 20762
        • Malcolm Grow Medical Clinics and Surgery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Battlefield Acupuncture (BFA)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
The DVPRS will be administered weekly for seven times. Followed by a one time washout 2 weeks later.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
A medication form will be administered weekly for seven times. Followed by a one time washout 2 weeks later.
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.
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
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.
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
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)
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
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)
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
The SF-8 is administered the first, fourth, and eighth week.
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.
Height, weight, and BMI is measured the first and eighth week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Geneva Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TriService Nursing Research Program

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Candy Wilson, PhD, Uniformed Services University of the Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N16-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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