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

Chronic Low-back Pain Clinical Trial

Official title: Evaluating Specific and Non-Specific Mechanisms in Two Distinct Complementary/Integrative Interventions for Chronic Pain

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This project will determine whether enhancing endogenous opioids (via SMT or MT) permits achieving desired levels of analgesia with lower dosages of opioid analgesics, and fewer side effects and abuse-relevant drug effects. This X year project will test study hypotheses in a sample of 240 chronic low back pain patients. The study will have 2 key elements: 1) a randomized, controlled SMT or MT in chronic pain (CP) patients completing daily take home exercises and 2) laboratory evoked thermal pain protocols pre- and post- therapy, permitting the quantification of EO function and the examining of treatment-induced changes in EO function (placebo vs. naloxone).

The study will employ a mixed between/within-subjects design using double-blinded and placebo-controlled administration of the opioid antagonist (naloxone). The study will use a 8 week supervised MT or SMT manipulation with subjects randomly assigned to one of the groups. All participants will undergo 6 laboratory pain-induction sessions in total. 2 during the pre-treatment phase, 2 during the mid-treatment phase, and 2 post-treatment. The laboratory sessions are identical with the exception of one of the 2 mid-treatment laboratory sessions, where extra questionnaires are administered. Each laboratory session will be roughly 2-3 days apart and the first 2 laboratory sessions will occur prior to the randomization to the treatment condition. ;

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

• NCT number: NCT04744883
• Study type: Interventional
• Source: Rush University Medical Center
• Contact: John Burns, PhD
• Phone: 312-942-0379
• Email: john_burns@rush.edu
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 10, 2020
• Completion date: July 31, 2024