Battlefield Acupuncture for Low Back Pain

Study Overview
=================
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?

Official Title
-----------------
Battlefield Acupuncture for Low Back Pain

Conditions
-----------------
Low Back Pain, Chronic Low Back Pain

Intervention / Treatment
-----------------
* Other: Auricular Acupuncture
* Other: Sham Treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Treatment<br>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<br>* Laser pointer pointed at the ear, but not turned on.<br>|
| Experimental: Auricular Acupuncture<br>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<br>* Up to five small ASP needles placed in each ear until pain is reduced to 1/10.<br>* Other names: Battlefield Acupuncture (BFA);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | The DVPRS will be administered weekly for seven times. Followed by a one time washout 2 weeks later. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain medication need. | 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. | 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 | 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 | 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 | 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. |