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NCT03520387 · ClinicalTrials.gov registry record · NA
Selecting Effective Combinations of Treatment for Low Back Pain
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT03520387: Completed NA study, sponsored by VA Office of Research and Development.
NCT03520387 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03520387, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
Back pain is the #1 contributor to disability in the United States (US), and second only to hearing problems as a reason for new Veteran disability compensation. The societal burden of back pain is driven mainly by chronic low back pain (CLBP), defined as low back pain persisting for 3 months. Since most individual treatments for CLBP have only small effects on functional recovery, combining CLBP treatments has recently been recommended as a priority area for research. However, few prior studies of CLBP have been properly designed to evaluate the effects of treatment combinations. Large effects on functional recovery from CLBP may require combining interventions that each target different points on a theoretical pathway to functional recovery. Procedural treatments for CLBP aim primarily to address early stages in the pathway to functional recovery, such as problems with the lumbar spinal structures or low back pain itself. In contrast, behavioral interventions for CLBP generally have effects not only on pain itself, but also work by mitigating the degree to which the sensation of low back pain impacts function, well-being, and quality of life. These represent later stages in the pathway to functional recovery from CLBP. Combining procedural and behavioral treatments may have great potential for achieving large magnitude treatment effects for CLBP in Veterans. The proposed research assesses the feasibility of using a 2 x 2 factorial randomized controlled trial (RCT) design to examine the individual and combined effects of 1) lumbar medial branch nerve radiofrequency ablation (LRFA), a commonly used procedural intervention to target low back pain severity, and 2) a novel video telehealth tablet- and personal computer (PC)-based Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program ("AcTIVE-CBT"), a behavioral intervention designed primarily to target functional limitations both secondary to, and independent of, improvements in pain. The LRFA t
Interventions
- PROCEDURE Lumbar medial branch nerve radiofrequency ablation (LRFA)
- PROCEDURE Simulated LRFA with targeted steroid injections
- BEHAVIORAL AcTIVE-CBT
- BEHAVIORAL TBSCE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2020-08-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03520387
The ClinicalTrials.gov registry entry for NCT03520387 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Lumbar medial branch nerve radiofrequency ablation (LRFA) is the first listed.
NCT03520387 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03520387 about?
NCT03520387 is a clinical study titled "Selecting Effective Combinations of Treatment for Low Back Pain". Back pain is the #1 contributor to disability in the United States (US), and second only to hearing problems as a reason for new Veteran disability compensation. The societal burden of back pain is driven mainly by chronic low back pain (CLBP), defined as low back pain persisting for 3 months. Since...
What is the current status of trial NCT03520387?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2018-11-15. Estimated completion is 2020-08-30.
What interventions are being tested in trial NCT03520387?
The interventions under investigation include: Lumbar medial branch nerve radiofrequency ablation (LRFA) (PROCEDURE), Simulated LRFA with targeted steroid injections (PROCEDURE), AcTIVE-CBT (BEHAVIORAL), TBSCE (BEHAVIORAL).
Who is sponsoring clinical trial NCT03520387?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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