Clinical trial NCT03491124: Battlefield Acupuncture for Low Back Pain
Official title: Battlefield Acupuncture for Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Chronic Low Back Pain
Lead sponsor: The Geneva Foundation
Sponsor class: OTHER
Collaborators: name: TriService Nursing Research Program
First posted: 2018-04-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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?


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

Primary outcomes:
measure: Pain level change over time on the Defense/Veterans Pain Rating Scale(DVPRS).
timeFrame: The DVPRS will be administered weekly for seven times. Followed by a one time washout 2 weeks later.
Secondary outcomes:
measure: Change in pain medication need.
timeFrame: A medication form will be administered weekly for seven times. Followed by a one time washout 2 weeks later.
measure: Change in trunk flexion.
timeFrame: 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.
measure: Change in balance
timeFrame: 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.
measure: Change in physical activity
timeFrame: 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.
measure: Change in sleep quality
timeFrame: 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:
measure: Health and well being
timeFrame: The SF-8 is administered the first, fourth, and eighth week.
measure: Height, weight, and Body Mass Index(BMI)
timeFrame: Height, weight, and BMI is measured the first and eighth week.
Locations:
city: Andrews Air Force Base
country: United States
facility: Malcolm Grow Medical Clinics and Surgery Center
state: Maryland
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Candy Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References: