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N/A

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

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 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

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
~2600

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,127 Previous Clinical Trials
1,793,047 Total Patients Enrolled
Eric Garland, PhDPrincipal InvestigatorUniversity of Utah
2 Previous Clinical Trials
480 Total Patients Enrolled

Media Library

Meditation (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT05607381 — N/A
Opioid Use Disorder Research Study Groups: Usual Care, Mindfulness, Meditation
Opioid Use Disorder Clinical Trial 2023: Meditation Highlights & Side Effects. Trial Name: NCT05607381 — N/A
Meditation (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05607381 — N/A
~87 spots leftby Apr 2027
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