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NCT03581123 · ClinicalTrials.gov registry record · Phase 3
Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain
A Phase 3 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,000
- Enrollment target
NCT03581123: Completed Phase 3 study, sponsored by University of Minnesota.
NCT03581123 is a Phase 3 study that has completed, run by University of Minnesota. The registered enrollment target is 1,000 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03581123, a Phase 3 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,000 participants
- Enrollment target
Study Summary
This is a study of adults with acute low back pain flare-up at risk of becoming chronic and disabling. The study tests how well spinal manipulation and guided selfcare work compared to standard medical care. The treatments last up to eight weeks and participants will be followed for one year.
Primary Outcome
Measured using the 0-10 numerical rating scale (0=no LBP, 10=the worst LBP possible). Missing weekly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline pain intensity.
Interventions
- OTHER Spinal Manipulation Therapy (SMT)
- DRUG Standard Medical Care (SMC)
- BEHAVIORAL Supported-Self Management (SSM)
- COMBINATION_PRODUCT SMT + SSM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2024-06-12 |
| Phase | Phase 3 |
What the finished NCT03581123 record still lists
NCT03581123 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 4 interventions - of which Spinal Manipulation Therapy (SMT) is the first listed.
NCT03581123 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03581123 about?
NCT03581123 is a clinical study titled "Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain". This is a study of adults with acute low back pain flare-up at risk of becoming chronic and disabling. The study tests how well spinal manipulation and guided selfcare work compared to standard medical care. The treatments last up to eight weeks and participants will be followed for one year.
What is the current status of trial NCT03581123?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2018-11-01. Estimated completion is 2024-06-12.
What interventions are being tested in trial NCT03581123?
The interventions under investigation include: Spinal Manipulation Therapy (SMT) (OTHER), Standard Medical Care (SMC) (DRUG), Supported-Self Management (SSM) (BEHAVIORAL), SMT + SSM (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03581123?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03581123's enrollment target sits among peer trials
1,000 296th of 2000 higher than 1,689 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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