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NCT04870957 · ClinicalTrials.gov registry record · Phase 4
The Back Pain Consortium Research Program Study
A Phase 4 study of Chronic Low Back Pain, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 494
- Enrollment target
- 1
- Study location
NCT04870957: Completed Phase 4 study of Chronic Low Back Pain, sponsored by University of Michigan.
NCT04870957 is a Phase 4 study of Chronic Low Back Pain that has completed, run by University of Michigan. The registered enrollment target is 494 participants, below the 585-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (16% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04870957, a Phase 4 study of Chronic Low Back Pain, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 494 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being completed to better understand who benefits from different chronic pain treatments and how these treatments work. This study will include a four week run-in period for all cLBP participants. After completing the PainGuide (online or smart phone accessible website) run-in period, participants will be assessed using either the light or light plus deep phenotyping assessment battery and those who minimal or modest improvement in their pain (based on PGIC) will be randomized to one of four 8-week treatments (mindfulness-based stress reduction (MBSR), physical therapy (PT) and exercise, acupressure self-management, or duloxetine). In addition, participants will complete study visits including physical exams, complete surveys, provide samples (blood,saliva, etc.), wear an electronic wrist device at certain times, and have Magnetic resonance imaging (MRIs) during the study. Following one of the 4 treatments (8 weeks) if participants have a certain level of pain (that meets eligibility for more treatment) they will be then randomized to complete one of the 3 treatments that was not already assigned to them. The study hypothesizes the following: that this interventional response phenotyping can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based interventions for chronic lower back pain (cLBP).
Primary Outcome
The PROMIS pain interference consists of 4 questions on a Likert scale ranging from 'Not at all" (1) to "Very much" (5). Total scores are between 4 and 20, with higher scores indicating increased pain interference.
Conditions Studied
Interventions
- DRUG Duloxetine
- BEHAVIORAL MBSR
- BEHAVIORAL PainGuide
- BEHAVIORAL PT and exercise
- DEVICE Self -administered acupressure
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 494 participants |
| Start Date | 2021-06-09 |
| Est. Completion | 2025-04-14 |
| Phase | Phase 4 |
What the finished NCT04870957 record still lists
NCT04870957 is an interventional study that assigns participants to a tested intervention. The registered 494 participants enrollment target is mid-sized for trials with a published cap, below the 585-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (16% lower).
The record links to 1 condition, with Chronic Low Back Pain appearing as the primary indexed condition, and to 5 interventions - of which Duloxetine is the first listed.
NCT04870957 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04870957 about?
NCT04870957 is a clinical study titled "The Back Pain Consortium Research Program Study". This study is being completed to better understand who benefits from different chronic pain treatments and how these treatments work. This study will include a four week run-in period for all cLBP participants. After completing the PainGuide (online or smart phone accessible website) run-in period,...
What is the current status of trial NCT04870957?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 494 participants. The study started on 2021-06-09. Estimated completion is 2025-04-14.
What conditions does trial NCT04870957 study?
This clinical trial studies the following conditions: Chronic Low Back Pain.
What interventions are being tested in trial NCT04870957?
The interventions under investigation include: Duloxetine (DRUG), MBSR (BEHAVIORAL), PainGuide (BEHAVIORAL), PT and exercise (BEHAVIORAL), Self -administered acupressure (DEVICE).
Who is sponsoring clinical trial NCT04870957?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04870957 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04870957's enrollment target sits among peer trials
494 9th of 71 higher than 63 of 71 other Chronic Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Low Back Pain 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.
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