Trials / Completed
CompletedNCT03491124
Battlefield Acupuncture for Low Back Pain
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- The Geneva Foundation · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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?
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Auricular Acupuncture | Up to five small ASP needles placed in each ear until pain is reduced to 1/10. |
| OTHER | Sham Treatment | Laser pointer pointed at the ear, but not turned on. |
Timeline
- Start date
- 2018-03-23
- Primary completion
- 2021-02-28
- Completion
- 2021-02-28
- First posted
- 2018-04-09
- Last updated
- 2021-07-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03491124. Inclusion in this directory is not an endorsement.