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Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With Chronic Low Back Pain
Sponsor: Rush University Medical Center
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.
Official title: Evaluating Specific and Non-Specific Mechanisms in Two Distinct Complementary/Integrative Interventions for Chronic Pain
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2020-08-15
Completion Date
2026-06-01
Last Updated
2025-07-10
Healthy Volunteers
No
Conditions
Interventions
Spinal Manipulation Therapy (SMT)
2 SMT techniques are administered each session, both of which are scripted interactions between the physical therapist (PT) providing the SMT and the subjects: 1) Participants will lie on the SMT table for 20 mins, while the PT sits approximately 6 ft away. As part of the script, the PT will review with subjects the inclusion/exclusion criteria ostensibly to ensure that nothing has changed. 2) The PT will perform the 2 SMT techniques during the next 20 mins. 3) Subjects will sit upright in a chair for the remaining 20 mins, while the PT sits approximately 6 feet away. The PT will review home exercises with participant.
Naloxone
In randomized order (crossover) across 2 laboratory sessions each approximately 3 days apart, participants will receive either 1) 2 doses of saline placebo (20ml each) or 2) weight-adjusted doses of Naloxone beginning with a dose of 0.11mg/kg followed by a weight-adjusted dose of 0.055 mg/kg
Placebo
In randomized order (crossover) across 2 laboratory sessions each approximately 3 days apart, participants will receive either 1) 2 doses of saline placebo (20ml each) or 2) weight-adjusted doses of Naloxone beginning with a dose of 0.11mg/kg followed by a weight-adjusted dose of 0.055 mg/kg
Mindfulness Based Stress Reduction Therapy (MT)
Each MT session consists of (a) body scan meditation accompanied by awareness of breathing and other bodily sensations while in a lying position, (b) sitting meditation, focusing on awareness of breathing, bodily sensations, thoughts, and emotions (c) gentle movement exercises intended to develop awareness (mindfulness) during movement. In-session activities include suggestions for application of mindfulness as a method for responding positively to stress; dealing with the challenges of pain; and exercises focusing on the challenges and achievements patients experience in integrating mindfulness into their lives and the stressful situations they encounter. Additional discussion will focus on stress reactivity and they will be taught problem-solving skills to develop solutions to meet MT goals. Finally, patients will develop a written maintenance plan that includes a list of short- and long-term goals for applying mindfulness methods and a plan for dealing with possible setbacks.
Locations (2)
Rush University Medical Center
Chicago, Illinois, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States