Low Back PainBFANCT03491124

Battlefield Acupuncture for Low Back Pain

A study testing Auricular Acupuncture in people with Low Back Pain and Chronic Low Back Pain, run by The Geneva Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Low Back Pain, Chronic Low Back Pain
What is being tested?: Auricular Acupuncture
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited States
Study dates: 23 Mar 2018to 28 Feb 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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?

Conditions: Low Back Pain, Chronic Low Back Pain
Being tested: Auricular Acupuncture, Sham Treatment
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Auricular AcupunctureOther
Also called Battlefield Acupuncture (BFA)
Up to five small ASP needles placed in each ear until pain is reduced to 1/10.
Sham TreatmentOther
Laser pointer pointed at the ear, but not turned on.

Study groups in NCT03491124
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Auricular Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 201828 Feb 2021

First posted9 Apr 2018
Study start23 Mar 2018
Primary completion28 Feb 2021
Study completion28 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03491124
Sponsor's protocol ID: N16-006
Acronym: BFA
Status last verified: Jul 2021
First submitted: 23 Mar 2018
Last updated: 29 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Battlefield Acupuncture for Low Back Pain
ClinicalTrials.gov ID: NCT03491124
Acronym / sponsor ID: BFA / N16-006
Conditions: Low Back Pain, Chronic Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: The Geneva FoundationUniversity, hospital or other
Collaborators: TriService Nursing Research Program
Study start: 23 Mar 2018 (actual)
Primary completion: 28 Feb 2021 (actual)
Study completion: 28 Feb 2021 (actual)
First posted: 9 Apr 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Sham Treatment	Sham comparator	Other: Sham TreatmentParticipants 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.
Auricular Acupuncture	Experimental	Other: Auricular AcupunctureParticipants 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.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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%

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Auricular AcupunctureAlso: Battlefield Acupuncture (BFA)Up to five small ASP needles placed in each ear until pain is reduced to 1/10.	Other	Auricular Acupuncture
Sham TreatmentLaser pointer pointed at the ear, but not turned on.	Other	Sham Treatment

Primary outcome

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).

5 secondary outcomes

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.
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.
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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.

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SERENITY Study of Chronic Pain Interference in Adults
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Candy Wilson, PhD principal investigator

Uniformed Services University of the Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Auricular Acupuncture in people with Low Back Pain and Chronic Low Back Pain, run by The Geneva Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03491124.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.