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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 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.

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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.

Conditions Studied

Chronic Low Back Pain

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

FieldValue
Enrollment Target 140 participants
Start Date 2020-08-15
Est. Completion 2026-06-01
Phase Early Phase 1

Sponsor

Rush University Medical Center

320 total trials

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What the Registry Record Tells You About NCT04744883

The ClinicalTrials.gov registry entry for NCT04744883 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 590-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (76% lower). The listed sponsor is Rush University Medical Center, which has 320 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 4 interventions - of which Placebo is the first listed.

NCT04744883 reports 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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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.