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NCT04744883 · ClinicalTrials.gov registry record · Early Phase 1
Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With Chronic Low Back Pain
A Early Phase 1 study of Chronic Low Back Pain, sponsored by Rush University Medical Center.
- Active
- Registry status
- Early Phase 1
- Development phase
- 140
- Enrollment target
- 2
- Study locations
NCT04744883: Active Early Phase 1 study of Chronic Low Back Pain, sponsored by Rush University Medical Center.
NCT04744883 is a Early Phase 1 study of Chronic Low Back Pain that is active but no longer recruiting, run by Rush University Medical Center. The registered enrollment target is 140 participants, below the 590-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04744883, a Early Phase 1 study of Chronic Low Back Pain, is active but no longer recruiting, sponsored by Rush University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 140 participants
- Enrollment target
- 2
- Study locations
Study Summary
Chronic Pain Management (CPM) has increasingly utilized long-term opioid analgesic therapy, a change associated with increased opioid abuse (a greater exposure in vulnerable individuals), non-pain health consequences (hormone changes, falls), and a dramatic rise in opioid-related overdoses and deaths. Treatment strategies that minimize the need for chronic high-dose opioids are sorely needed. This project will aim to test what degree mindfulness therapy (MT) and spinal manipulation therapy (SMT) produce pre- to mid- to post-treatment changes in endogenous opioid (EO) function.
Primary Outcome
Interference in daily activities attributed to chronic pain as reported by subjects. The PROMIS Pain Interference scale consists of 8 questions with a 5-point response scale ranging from Not at all - Very much. Participants are asked how much in the past 7 days everyday activities were affected by their pain. Higher scores indicate more pain interference in daily activities.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Naloxone
- OTHER Spinal Manipulation Therapy (SMT)
- BEHAVIORAL Mindfulness Based Stress Reduction Therapy (MT)
Study Locations (2)
Illinois
- Rush University Medical Center - Chicago
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2020-08-15 |
| Est. Completion | 2026-06-01 |
| Phase | Early Phase 1 |
What the registry record for NCT04744883 still lists
NCT04744883 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 590-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Chronic Low Back Pain appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04744883 reports a single indexed study location in Illinois, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04744883 about?
NCT04744883 is a clinical study titled "Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With Chronic Low Back Pain". Chronic Pain Management (CPM) has increasingly utilized long-term opioid analgesic therapy, a change associated with increased opioid abuse (a greater exposure in vulnerable individuals), non-pain health consequences (hormone changes, falls), and a dramatic rise in opioid-related overdoses and death...
What is the current status of trial NCT04744883?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 140 participants. The study started on 2020-08-15. Estimated completion is 2026-06-01.
What conditions does trial NCT04744883 study?
This clinical trial studies the following conditions: Chronic Low Back Pain.
What interventions are being tested in trial NCT04744883?
The interventions under investigation include: Placebo (DRUG), Naloxone (DRUG), Spinal Manipulation Therapy (SMT) (OTHER), Mindfulness Based Stress Reduction Therapy (MT) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04744883?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04744883 being conducted?
This trial has 2 study locations across Illinois, Tennessee. 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 NCT04744883's enrollment target sits among peer trials
140 25th of 71 higher than 47 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
-
Mobile Neurofeedback for Low Back Pain
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-
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-
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RECRUITING · NA
-
PRECISION Pain Research Registry
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-
Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response
RECRUITING · NA
-
Meditation for Older Adults With Chronic Low Back Pain
RECRUITING · NA
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