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NCT05396014 · ClinicalTrials.gov registry record · Phase 4
The BEST Trial: Biomarkers for Evaluating Spine Treatments
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,014
- Enrollment target
NCT05396014: Completed Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT05396014 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 1,014 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05396014, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,014 participants
- Enrollment target
Study Summary
The BEST Trial (Biomarkers for Evaluating Spine Treatments) is a National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)-sponsored clinical trial being conducted through the NIH Helping to End Addiction Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. The primary objective of this trial is to inform a precision medicine approach to the treatment of Chronic Low-Back Pain by estimating the optimal treatment or combination of treatments based on patient features and response to the initial treatment. Interventions being evaluated in this trial are: (1) enhanced self-care (ESC), (2) acceptance and commitment therapy (ACT), (3) evidence-based exercise and manual therapy (EBEM), and (4) duloxetine.
Primary Outcome
Patient-reported pain intensity and interference is measured by the Pain, Enjoyment of Life, and General Activity (PEG) scale. The PEG is a series of 3 questions. Results range from -10 to 10, with higher scores indicating increased pain intensity and interference at 24 Weeks compared to Baseline.
Interventions
- DRUG Duloxetine
- BEHAVIORAL Acceptance and Commitment Therapy (ACT)
- BEHAVIORAL Enhanced Self-Care (ESC)
- BEHAVIORAL Evidence-Based Exercise and Manual Therapy (EBEM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,014 participants |
| Start Date | 2022-09-12 |
| Est. Completion | 2024-10-22 |
| Phase | Phase 4 |
What the finished NCT05396014 record still lists
NCT05396014 is an interventional study that assigns participants to a tested intervention. Its 1,014 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% higher).
The record links to 0 conditions, and to 4 interventions - of which Duloxetine is the first listed.
NCT05396014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05396014 about?
NCT05396014 is a clinical study titled "The BEST Trial: Biomarkers for Evaluating Spine Treatments". The BEST Trial (Biomarkers for Evaluating Spine Treatments) is a National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)-sponsored clinical trial being conducted through the NIH Helping to End Addiction Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Progra...
What is the current status of trial NCT05396014?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,014 participants. The study started on 2022-09-12. Estimated completion is 2024-10-22.
What interventions are being tested in trial NCT05396014?
The interventions under investigation include: Duloxetine (DRUG), Acceptance and Commitment Therapy (ACT) (BEHAVIORAL), Enhanced Self-Care (ESC) (BEHAVIORAL), Evidence-Based Exercise and Manual Therapy (EBEM) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05396014?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05396014's enrollment target sits among peer trials
1,014 66th of 2000 higher than 1,935 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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