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Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With Chronic Low Back Pain

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Study completion date: Jun 1, 2025 to Jun 1, 2026v11
  2. Primary completion date: Nov 30, 2024 to Nov 29, 2024
    • Study completion date: Jul 31, 2025 to Jun 1, 2025
    • Start date: Aug 10, 2020 to Aug 15, 2020
    v10
  3. Re-verified, no change to tracked fieldsv9
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 240 to confirmed 140
    • Primary completion date: Jul 31, 2025 to Nov 30, 2024
    • Site details revised at 2 of 2 sites
    v8
  5. Re-verified, no change to tracked fieldsv7
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  1. Primary and study completion dates: Jul 31, 2024 to Jul 31, 2025
    • Study description shortened, about 21 words
    v6
  2. 2 versions Re-verified since Feb 15, 2024, no change to tracked fieldsv4-v5
  3. Primary and study completion dates: Jul 2023 to Jul 31, 2024v3
  4. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04744883
Lead Sponsor Rush University Medical Center
Collaborators: Vanderbilt University Medical Center
Conditions
(from sponsor)		 Chronic Low-back Pain
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov