Battlefield Acupuncture for Low Back Pain
- Conditions
- Low Back PainChronic Low Back Pain
- Interventions
- Other: Auricular AcupunctureOther: Sham Treatment
- Registration Number
- NCT03491124
- Lead Sponsor
- The Geneva Foundation
- 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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Auricular Acupuncture 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. Sham Treatment 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.
- Primary Outcome Measures
Name Time Method Pain level change over time on the Defense/Veterans Pain Rating Scale(DVPRS). 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).
- Secondary Outcome Measures
Name Time Method Change in sleep quality 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)
Change in pain medication need. 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.
Change in balance 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.
Change in physical activity 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)
Change in trunk 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. Trunk flexion will be assessed with Dual Digital Inclinometers. The Dual Digital Inclinometer is placed around the sacrum and measures the angle of flexion.
Trial Locations
- Locations (1)
Malcolm Grow Medical Clinics and Surgery Center
🇺🇸Andrews Air Force Base, Maryland, United States