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Mindfulness Based Pain Reduction for Chronic Lower Back Pain (MBPR Trial)
N/A
Waitlist Available
Led By Wolf E Mehling, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post 8-week intervention, 6 months follow-up
Awards & highlights
MBPR Trial Summary
This trial is testing a new mindfulness-based pain reduction program to see if it's more effective than the existing mindfulness-based stress reduction program.
Eligible Conditions
- Chronic Lower Back Pain
MBPR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post 8-week intervention, 6 months follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post 8-week intervention, 6 months follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain Intensity
Secondary outcome measures
Pain Interference
Other outcome measures
Changes in insula cortex activation / connectivity
Interoceptive Awareness
MBPR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1Experimental Treatment1 Intervention
4 cohorts of 10 participants to MBPR (First 3 groups single-arm, final group of 10 randomly assigned to MBPR)
Group II: Group 2Active Control1 Intervention
The last 20 participants will be randomly assigned to MBSR or MBPR, which will results in a control group with ~10 participants undergoing MBSR
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,510 Previous Clinical Trials
15,243,655 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
835 Previous Clinical Trials
669,488 Total Patients Enrolled
Wolf E Mehling, MDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
74 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a smartphone.Only adults 18 years old and older are being enrolled in the study because the program is for adults, not children.Your average pain in the last month needs to be at least a 3 out of 10 on a pain scale. If your pain is less than that, it may be too mild to see if the treatment helps.You have or had an infection, tumor, fracture, or nerve issue in your spine.You have severe vision or hearing problems, bipolar or major depression without medication, substance abuse, dementia, or difficulty getting up and down from the floor, which might make it hard for you to take part in the study.You have serious medical conditions like untreated hypothyroidism, kidney failure, or cirrhosis, which could affect the study results.You are involved in a legal case related to your back, or have complicated legal issues that could influence your reporting of improvement.You are currently pregnant, breastfeeding, or planning to become pregnant soon, or have recently given birth.You do not have a stable place to live, or you plan to move away in the next 6 months.You have had pain in your lower back for at least half of the days in the past 6 months, as shown by specific questions and a drawing of the pain area.If you have had back pain for more than three months and it has bothered you at least half the days in the past 6 months, you may be eligible for the study.You have any of the following: a pacemaker, metal fragments in your body, history of specific medical procedures, certain medical devices, vision problems that can't be corrected, or difficulties lying still for about an hour. These can cause issues during the MRI scan.You have a medical or mental health condition that might make it hard for you to take part in the study, or that may require immediate changes in your medical care that could affect the study results. This includes certain conditions like specific types of cancer, liver failure, and others listed. If you have significant substance abuse or mental health conditions that interfere with daily life, you might not be able to participate. If you need immediate surgery or have unstable medical conditions, you may not be eligible for the study.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2
- Group 2: Group 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on participants in this research project?
"Indeed, clinicaltrials.gov states that this medical trial is still recruiting patients since first posted on December 14th 2021 and last modified October 13th 2022. 50 individuals are needed to be recruited from 1 particular site in order for the study to continue."
Answered by AI
Is recruitment still open for this experiment?
"Affirmative, clinicaltrials.gov attests that this research initiative is currently searching for participants. It was initially posted on December 14th 2021 and the latest update was published October 13th 2022. 50 individuals must be recruited from a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of California San Francisco; Osher Center for Intgerative Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
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