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Meditation for Chronic Low Back Pain

N/A

Recruiting

Led By Eric Garland, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current use of prescription opioids for ≥3 months

Men/women 18-65 years of age

Must not have

Current cancer diagnosis

Those unable to lie still on their back for 1 to 1.5 hours

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, post-treatment (8 weeks), and 3-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial examines how a mindfulness meditation-based intervention could reduce pain in patients with chronic low back pain treated with opioids.

Who is the study for?

This trial is for men and women aged 18-65 who have chronic low back pain, score it at least a 3 out of 10 even with opioid medication, and have been on prescription opioids for over three months. It's not open to those with meditation training, current cancer, recent suicide attempts, psychosis or severe substance use disorder in the last six months.

What is being tested?

The study is testing how mindfulness meditation affects pain relief in patients with chronic low back pain treated with opioids. Participants will either receive this meditation-based therapy or continue their usual care while researchers study changes in their brain related to pain.

What are the potential side effects?

Since the intervention involves meditation rather than medication, side effects are minimal but may include temporary increases in anxiety or discomfort during initial practice sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been using prescription opioids for at least 3 months.

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I am between 18 and 65 years old.

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My back pain is 3 or more on a scale of 0-10, even with opioid medication.

Exclusion Criteria

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

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I am currently diagnosed with cancer.

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I can lie still on my back for up to 1.5 hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, post-treatment (8 weeks), and 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, post-treatment (8 weeks), and 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, post-treatment (8 weeks), and 3-month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Oxyhemoglobin

Secondary study objectives

Pain

Mindful reinterpretation of pain sensations

Opioids

+4 more

Other study objectives

Cue-reactivity

Heart rate variability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: MindfulnessExperimental Treatment2 Interventions

A well-validated mindfulness meditation-based therapy \[8 sessions\] is used to teach patients to independently practice meditation to cope with pain.

Group II: MeditationExperimental Treatment2 Interventions

A validated meditation-based therapy \[8 sessions\] is used to teach patients to independently practice meditation to cope with pain.

Group III: Usual CareActive Control1 Intervention

Patients will receive usual medical care for chronic low back pain.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Meditation

2021

Completed Phase 3

~2940