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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Oxyhemoglobin

Secondary outcome measures

Pain

Mindful reinterpretation of pain sensations

Opioids

+4 more

Other outcome measures

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

~2740

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,100 Previous Clinical Trials

1,778,751 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are senior citizens being included in this research project?

"This study is seeking to include individuals who are in the 18-65 age range."

Answered by AI

Is there capacity available in this trial for new participants?

"As reported by clinicaltrials.gov, the recruitment phase of this medical trial is still ongoing. The study was originally posted on December 27th 2022 and updated most recently on January 11 2023."

Answered by AI

What is the maximum capacity of individuals involved in this research endeavor?

"Affirmative. Clinicaltrials.gov reveals that this medical research project, initially posted on December 27th 2022, is in search of participants at present. The study requires 150 test subjects from a single site to begin their trials."

Answered by AI

Is it possible for me to be enrolled in this research initiative?

"This clinical trial seeks to enrol 150 individuals with chronic lower back pain, aged between 18 and 65. Eligibility requirements state that candidates must be male or female adults, their usual daily pain should register 3/10 on the 0-10 scale while taking opioid medication, and they need to have been using prescription opioids for a minimum of three months."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain

Eric Garland 2022. "Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05607381.

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