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Behavioral Intervention

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

Phase < 1

Waitlist Available

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

Must not have

Inability to hold breathe for 15 seconds

Long term use of corticosteroids

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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot hold my breath for 15 seconds.

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I have been using corticosteroids for a long time.

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I have osteoporosis or weak bones.

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I have had thoughts of taking my own life with a plan.

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I have had lumbar (lower back) surgery in the last 6 months.

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I have recently injured my spine.

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My BMI is 40 or higher.

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I have a liver disease, like hepatitis or cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

Naloxone

FDA approved

Placebo

1995

Completed Phase 3

~2670

0 / 11Eligibility criteria met