Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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).

Conditions Studied

Chronic Low Back Pain

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

FieldValue
Enrollment Target 494 participants
Start Date 2021-06-09
Est. Completion 2025-04-14
Phase Phase 4

Sponsor

University of Michigan

1,327 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04870957

The ClinicalTrials.gov registry entry for NCT04870957 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 494 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (16% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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

Similar trials for Chronic Low Back Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Chronic Low Back Pain

All registered trials for this condition

Michigan

All trials with a study site in Michigan

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.