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

NCT04744883 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 17100503
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief 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

Chronic Low-back Pain

Keywords

chronic low back pain

Outcome Measures

Primary Outcomes (1)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

  Interference in daily activities attributed to chronic pain as reported by subjects. The PROMIS Pain Interference scale consists of 8 questions with a 5-point response scale ranging from Not at all - Very much. Participants are asked how much in the past 7 days everyday activities were affected by their pain. Higher scores indicate more pain interference in daily activities.

  Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

Secondary Outcomes (4)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (Short Form)

  Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression

  Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form)

  Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance

  Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

Study Arms (2)

SMT plus placebo/naloxone

EXPERIMENTAL

Participants are randomly assigned to an 8 week SMT treatment group conducted by certified physical therapists. Immediately before and after the treatment sessions along with midway through the treatment (after 4 sessions), participants will undergo the placebo/naloxone administration intervention to assess mechanisms of SMT or MT-related changes.

Other: Spinal Manipulation Therapy (SMT); Drug: Naloxone; Drug: Placebo

MT plus placebo/naloxone

EXPERIMENTAL

Participants are randomly assigned to an 8 week MT treatment group conducted by certified clinical therapists. Immediately before and after the treatment sessions along with midway through the treatment (after 4 sessions), participants will undergo the placebo/naloxone administration intervention to assess mechanisms of SMT or MT-related changes.

Drug: Naloxone; Drug: Placebo; Behavioral: Mindfulness Based Stress Reduction Therapy (MT)

Interventions

Spinal Manipulation Therapy (SMT) OTHER

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.

SMT plus placebo/naloxone

Naloxone DRUG

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

Also known as: narcan

MT plus placebo/naloxone; SMT plus placebo/naloxone

Placebo DRUG

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

Also known as: normal saline placebo

MT plus placebo/naloxone; SMT plus placebo/naloxone

Mindfulness Based Stress Reduction Therapy (MT) BEHAVIORAL

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.

MT plus placebo/naloxone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• significant daily chronic pain intensity (≥4 on a 10-point scale) and interference in performing daily activities due to pain (≥3 on a 10-point scale) for at least 3 months
• age 18-75 years (inclusive)
• not using opioid analgesics on a daily basis or within 3 days of each laboratory session (confirmed via urine drug screen)
• Intact cognitive status and ability to provide informed consent
• ability to read and write in English sufficiently to understand and complete study questionnaires

You may not qualify if:

• meet criteria for alcohol or substance abuse problems
• meet criteria for past or present psychotic or bipolar disorders
• inability to understand English well enough to complete questionnaires or participate in therapy
• pain due to malignant conditions, rheumatoid arthritis, migraine or tension headache, complex regional pain syndrome, or fibromyalgia syndrome
• lumbar surgery within past 6 months
• pregnant
• signs of nerve root compression (ie, positive straight-leg raise \<45○).
• liver diseases (e.g hepatitis or cirrhosis)
• suicide ideation with intent
• osteoporosis or bone demineralization
• opioid-dependency
• inability to hold breathe for 15 seconds
• acute trauma to spine
• long term use of corticosteroids
• spinal cord stimulator or IT pump inserted in back

Sponsors & Collaborators

• Rush University Medical Center: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

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MeSH Terms

Interventions

Naloxone; Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• John Burns, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Stephen Bruehl, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: February 9, 2021
• Study Start: August 15, 2020
• Primary Completion: November 29, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

US (2)