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Behavioral Intervention

Spinal Manipulation and Mindfulness-Based Stress Reduction for Chronic Lower Back Pain

Phase < 1
Recruiting
Led By Stephen Bruehl, PhD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Intact cognitive status and ability to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)
Awards & highlights

Study Summary

This trial will aim to test the effectiveness of mindfulness therapy and spinal manipulation therapy in reducing the need for chronic high-dose opioids by measuring changes in endogenous opioid function.

Who is the study for?
This trial is for adults aged 18-75 with chronic low back pain, who experience significant daily pain and interference in daily activities. Participants must not be on opioids, have intact cognitive abilities, and be able to consent and complete questionnaires in English. Exclusions include severe health conditions like osteoporosis, recent lumbar surgery, high BMI (40+), certain mental health issues, substance abuse problems, or specific other pain conditions.Check my eligibility
What is being tested?
The study tests the effectiveness of Mindfulness Based Stress Reduction Therapy (MT) and Spinal Manipulation Therapy (SMT) against a placebo in reducing chronic lower back pain without relying on long-term opioid use. It will also examine changes in the body's own opioid function before and after treatment.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort or soreness from SMT sessions or emotional distress during MT sessions. Placebo typically has no side effects but can lead to perceived symptoms due to the placebo effect.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had significant daily pain for at least 3 months that affects my daily activities.
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I am mentally capable of understanding and agreeing to the study.
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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Secondary outcome measures
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (Short Form)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: SMT plus placebo/naloxoneExperimental Treatment3 Interventions
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.
Group II: MT plus placebo/naloxoneExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Naloxone
FDA approved

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
424 Previous Clinical Trials
156,495 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
866 Previous Clinical Trials
672,435 Total Patients Enrolled
Stephen Bruehl, PhDPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
237 Total Patients Enrolled
~5 spots leftby Jul 2024
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