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Mindfulness Meditation for Chronic Lower Back Pain

N/A

Waitlist Available

Led By Fadel Zeidan, PhD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

Participants must be between the ages of 18-65 years.

Participants must rate their daily chronic pain intensity at a 3 or greater on 0-10 visual analog scale.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 fmri sessions (visit 1, 2, 9, and 16). active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

Awards & highlights

Study Summary

This trial will investigate whether mindfulness, or listening to a book, can change brain activity in response to pain.

Who is the study for?

This trial is for adults aged 18-65 with chronic low back pain lasting at least 3 months, who experience pain when lifting their legs and have no prior meditation experience. They must not be undergoing new pain treatments, have had recent back surgery, or possess metal implants that affect MRI scans. Pregnant individuals or those over 275 pounds are excluded.Check my eligibility

What is being tested?

The study tests if mindfulness through meditation training changes brain responses to potential leg-lift-induced pain using fMRI imaging, compared to a control group listening to an audiobook. It aims to understand how mental training influences brain activity related to chronic lower back pain.See study design

What are the potential side effects?

While the study itself may not directly cause side effects, participants might experience discomfort from remaining still during fMRI scans or temporary increased awareness of pain due to focused attention during meditation.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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My daily pain level is 3 or higher on a scale of 0 to 10.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3 fmri sessions (visit 1, 2, 9, and 16). active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3 fmri sessions (visit 1, 2, 9, and 16). active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 fmri sessions (visit 1, 2, 9, and 16). active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute)

Secondary outcome measures

Mental Depression

Blood Oxygen Dependent Signaling

Brief Pain Inventory

+9 more

Other outcome measures

Chronic Pain Acceptance Questionnaire

PROMIS 29-Item Profile

PROMIS Pain Quality Measure

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: mindfulness groupExperimental Treatment1 Intervention

Study volunteers will participate in a six-session meditation training regimen. In brief, subjects will be taught that perceived sensory events are "momentary" and "fleeting" and do not require further evaluation. There will be an emphasis on breath focus and altering one's perspective of discursive sensory events. This intervention has been found to reliably attenuate the subjective experience of pain.

Group II: book-listeningActive Control1 Intervention

Study volunteers will listen to an audio recording of the Natural History of Selborne across each session.This 6 session intervention is meant to provide the control attention to the facilitator, room setting, social support, conditioning, and the time elapsed during the other respective interventions. We do not expect that this group will demonstrate significant cerebral blood flow changes as a function of the intervention.

Group III: non-mindfulness groupPlacebo Group1 Intervention

Study volunteers will participate in a six-session meditation training regimen. In brief, subjects will be taught to take deep breaths and relax.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mindfulness training

2011

N/A

~770

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,287 Total Patients Enrolled

Fadel Zeidan, PhDPrincipal Investigator - Principal Investigator

University of California, San Diego

5 Previous Clinical Trials

188 Total Patients Enrolled

Media Library

Meditatin training Clinical Trial Eligibility Overview. Trial Name: NCT03354585 — N/A

Chronic Lower Back Pain Research Study Groups: book-listening, mindfulness group, non-mindfulness group

Chronic Lower Back Pain Clinical Trial 2023: Meditatin training Highlights & Side Effects. Trial Name: NCT03354585 — N/A

Meditatin training 2023 Treatment Timeline for Medical Study. Trial Name: NCT03354585 — N/A

Frequently Asked Questions

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

Are there vacancies available for individuals to partake in this study?

"Clinicaltrials.gov confirms that, as of April 5th 2022, this study is actively searching for trial participants. It was initially listed on the website in February 2020."

Answered by AI

Does the trial's age criterion include participants over 25?

"This clinical trial is exclusively for individuals aged 18-65. Those younger than 18 can look into the 11 trials available to them, while adults over 65 have access to 264 studies."

Answered by AI

What is the maximum number of participants permitted in this experiment?

"Indeed, the clinicaltrials.gov database states that this research is actively seeking to enroll participants. It was initially posted on February 1st 2020 and has been recently updated as of May 4th 2022. This trial needs 120 patients from 3 medical institutions for completion."

Answered by AI

What criteria must potential participants meet to join this investigation?

"This medical trial is inviting 120 individuals aged 18-65 who have had low back pain for at least three months. Applicants must also report a 3 or greater on the 0-10 visual analog scale, lack prior meditative experience and be right handed to qualify for participation."

Answered by AI