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Mindfulness-Based Pain Reduction for 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
No Placebo-Only Group
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.
Who is the study for?
This trial is for adults with chronic low back pain, experiencing pain on most days over the past 6 months. Participants must have a smartphone, speak English, and rate their pain at least 3 out of 10. Exclusions include severe medical conditions like spine tumors or fractures, major mental health issues, recent back injections, pregnancy-related back problems, unstable housing plans, and certain MRI contraindications.
What is being tested?
The study tests an 8-week Mindfulness-Based Pain Reduction (MBPR) program designed to help individuals manage chronic pain. It will be refined based on feedback before comparing it to Mindfulness-Based Stress Reduction (MBSR) in future trials. The study includes tasks measuring attention to pain during heat application.
What are the potential side effects?
As MBPR involves mindfulness practices rather than medication or invasive procedures, significant side effects are not anticipated. However, participants may experience emotional discomfort when learning to confront painful sensations mindfully.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Intensity
Secondary study objectives
Pain Interference
Other study objectives
Changes in insula cortex activation / connectivity
Interoceptive Awareness
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,583 Previous Clinical Trials
15,084,014 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
853 Previous Clinical Trials
671,688 Total Patients Enrolled
Wolf E Mehling, MDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
74 Total Patients Enrolled
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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
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