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NCT04747314 · ClinicalTrials.gov registry record · Phase 2
Treating Negative Affect in Low Back Pain Patients
A Phase 2 study of Chronic Low Back Pain and Negative Affectivity, sponsored by Ajay Wasan, MD, Msc.
- Completed
- Registry status
- Phase 2
- Development phase
- 308
- Enrollment target
- 3
- Study locations
NCT04747314: Completed Phase 2 study of Chronic Low Back Pain and Negative Affectivity, sponsored by Ajay Wasan, MD, Msc.
NCT04747314 is a Phase 2 study of Chronic Low Back Pain and Negative Affectivity that has completed, run by Ajay Wasan, MD, Msc. The registered enrollment target is 308 participants, below the 588-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (48% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04747314, a Phase 2 study of Chronic Low Back Pain and Negative Affectivity, has completed, sponsored by Ajay Wasan, MD, Msc.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 308 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will examine how the use of antidepressant, physical therapy, and combination of both affects pain, function, and depression outcomes in chronic low back pain patients.
Primary Outcome
To create the "composite responder" measure, Pain+ function changes will be 1 meaure, and the response rate to depression will be the 2nd component, which simplifies the assessment of multi-domain responses. We will determine the "composite responder" rate of multimodal vs. single-modal treatment primarily, and then between each arm secondarily, along with the subcomponents. The "composite responder" measure will be the number and percentage of participants meeting the measure in each arm in Pha
Conditions Studied
Interventions
- DRUG Antidepressant
- OTHER Enhanced Fear Avoidance Rehabilitation
Study Locations (3)
Massachusetts
- BWH Pain Management Center - Chestnut Hill
Minnesota
- Mayo Clinic - Rochester
Pennsylvania
- UPMC Pain Medicine At Centre Commons - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2021-03-31 |
| Est. Completion | 2024-12-20 |
| Phase | Phase 2 |
What the finished NCT04747314 record still lists
NCT04747314 is an interventional study that assigns participants to a tested intervention. The registered 308 participants enrollment target is mid-sized for trials with a published cap, below the 588-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with Chronic Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Antidepressant is the first listed.
NCT04747314 reports a single indexed study location in Massachusetts, Minnesota, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04747314 about?
NCT04747314 is a clinical study titled "Treating Negative Affect in Low Back Pain Patients". This study will examine how the use of antidepressant, physical therapy, and combination of both affects pain, function, and depression outcomes in chronic low back pain patients.
What is the current status of trial NCT04747314?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 308 participants. The study started on 2021-03-31. Estimated completion is 2024-12-20.
What conditions does trial NCT04747314 study?
This clinical trial studies the following conditions: Chronic Low Back Pain, Negative Affectivity.
What interventions are being tested in trial NCT04747314?
The interventions under investigation include: Antidepressant (DRUG), Enhanced Fear Avoidance Rehabilitation (OTHER).
Who is sponsoring clinical trial NCT04747314?
This trial is sponsored by Ajay Wasan, MD, Msc, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04747314 being conducted?
This trial has 3 study locations across Massachusetts, Minnesota, Pennsylvania. 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.
Where NCT04747314's enrollment target sits among peer trials
308 14th of 71 higher than 58 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure
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Low-Dose Naltrexone and Acetaminophen Combination in the Treatment of Chronic Low Back Pain (ANODYNE-4)
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-
Chronic Low Back Pain Research Project
COMPLETED · Phase 2
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