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NCT04744883
Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With Chronic Low Back Pain
EARLY_PHASE1 trial testing Spinal Manipulation Therapy (SMT) in Chronic Low-back Pain in 140 participants. Participants enrolled and being followed up; not accepting new ones.
29 November 2024
Quick facts
| Lead sponsor | Rush University Medical Center |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 15 August 2020 |
| Primary completion | 29 November 2024 |
| Estimated completion | 1 June 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Spinal Manipulation Therapy (SMT)
- Naloxone (NALOXONE) — full drug profile →
- Placebo
- Mindfulness Based Stress Reduction Therapy (MT)
Conditions studied
- Chronic Low-back Pain — all drugs for Chronic Low-back Pain →
Sponsor
Rush University Medical Center
Who can join
Adults 18 to 75, any sex, with Chronic Low-back Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04744883
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Spinal Manipulation Therapy (SMT)
Trials testing the same drug.
- NCT04142177 — Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response · NA · recruiting
- NCT03581123 — Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain · Phase 3 · completed
Other recruiting trials for Chronic Low-back Pain
Currently open trials in the same condition.
- NCT06891625 — Movement Performance in Persons With Chronic Back Pain · NA · recruiting
- NCT06568198 — Modulation Effect of tACS on Chronic Low Back Pain · Phase 2 · recruiting
- NCT06825390 — AuriculoTherapy NeuroImaging · NA · recruiting
- NCT04824248 — Weight Reduction in CLBP · NA · recruiting
- NCT07055802 — Effects Of Inversion Table Therapy Vs MT On Pain And Lumbar Flexibility In Patients With Chronic Low Back Pain · NA · active not recruiting
Other Rush University Medical Center trials
Trials by the same sponsor.
- NCT07278076 — Clinical Decision-Making During FEES: The Impact of Residue Amount and Location · NA · not yet recruiting
- NCT07088120 — PRECISION-CPR: PRecision-Controlled Ventilation in CPR · NA · not yet recruiting
- NCT06894719 — Oral Tranexamic Acid After Total Knee Arthroplasty · Phase 4 · not yet recruiting
- NCT06229392 — A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer · Phase 1 · withdrawn
- NCT07452406 — Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04744883 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rush University Medical Center
- Last refreshed: 10 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04744883.
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