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NCT03491124 · ClinicalTrials.gov registry record · NA
Battlefield Acupuncture for Low Back Pain
A NA study of Low Back Pain and Chronic Low Back Pain, sponsored by The Geneva Foundation.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT03491124 is a NA study of Low Back Pain and Chronic Low Back Pain that has completed, run by The Geneva Foundation. The registered enrollment target is 48 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03491124, a NA study of Low Back Pain and Chronic Low Back Pain, has completed, sponsored by The Geneva Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- OTHER Sham Treatment
- OTHER Auricular Acupuncture
Study Locations (1)
Maryland
- Malcolm Grow Medical Clinics and Surgery Center - Andrews Air Force Base
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2018-03-23 |
| Est. Completion | 2021-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03491124
The ClinicalTrials.gov registry entry for NCT03491124 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (90% lower). The listed sponsor is The Geneva Foundation, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Sham Treatment is the first listed.
NCT03491124 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03491124 about?
NCT03491124 is a clinical study titled "Battlefield Acupuncture for Low Back Pain". 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 ma...
What is the current status of trial NCT03491124?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2018-03-23. Estimated completion is 2021-02-28.
What conditions does trial NCT03491124 study?
This clinical trial studies the following conditions: Low Back Pain, Chronic Low Back Pain.
What interventions are being tested in trial NCT03491124?
The interventions under investigation include: Sham Treatment (OTHER), Auricular Acupuncture (OTHER).
Who is sponsoring clinical trial NCT03491124?
This trial is sponsored by The Geneva Foundation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03491124 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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