Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| TriService Nursing Research Program | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
To explore the effectiveness of BFA on trunk flexion mobility and balance.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular Acupuncture | Other | Up to five small ASP needles placed in each ear until pain is reduced to 1/10. |
|
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Health and well being | 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) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Candy Wilson, PhD | Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malcolm Grow Medical Clinics and Surgery Center | Andrews Air Force Base | Maryland | 20762 | United States |
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Treatment | Other | Laser pointer pointed at the ear, but not turned on. |
|
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. |
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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |