CompletedNot Applicable

Development and Feasibility of Mindfulness Based Pain Reduction

United States52 participantsStarted 2021-12-14

Plain-language summary

This is a development study with clinical outcomes. The investigators aim to develop and test an 8-week MBPR (Mindfulness-Based Pain Reduction) program, which draws on intervention work and clinical experience in the investigative team to optimize a mindfulness-based intervention for individuals with chronic pain. The overall goal of this study is to ensure that the MBPR program has been carefully refined and manualized in an in-person setting before performing clinical trials comparing MBPR to MBSR (Mindfulness-Based Stress Reduction) to test whether it improves pain outcomes. This study includes a Pain Attention Task that separates insula activation during experimental heat application between different pain attention conditions.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Chronic low back pain (cLBP) defined according to the NIH Research Task Force recommendation on Research Standards for cLBP: pain at least half the days in the past 6 months, by using 2 questions and a human figure drawing illustrating the region as the space between the lower posterior margin of the rib cage and the horizontal gluteal fold.
. Average pain in the last month at least 3 out of 10 on Numeric Rating Scale \[range 0 - 10, for 0 signifying no pain and 10 signifying worst pain imaginable\]. This level of pain allows comparability of the study results with the majority of cLBP studies. Pain rated less than 3 is too mild to detect improvement.
. Men and women aged 18 years old and older. The investigators are not enrolling younger children as they are not part of the Intensive Pain Rehabilitation Therapy program.
. Eligibility will be assessed using the following questions: "(1) How long has back pain been an ongoing problem for you? and (2) How often has low-back pain been an ongoing problem for you over the past 6 months?" A response of greater than three months to question 1, and a response of "at least half the days in the past 6 months" to question 2 would meet the cLBP eligibility criterion.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Intensity

Timeframe: baseline, post 8-week intervention

Trial details

NCT IDNCT04980612

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-01

Results submitted2025-01-30

View on ClinicalTrials.gov More Chronic Low-back Pain trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Chronic low back pain (cLBP) defined according to the NIH Research Task Force recommendation on Research Standards for cLBP: pain at least half the days in the past 6 months, by using 2 questions and a human figure drawing illustrating the region as the space between the lower posterior margin of the rib cage and the horizontal gluteal fold.
. Average pain in the last month at least 3 out of 10 on Numeric Rating Scale \[range 0 - 10, for 0 signifying no pain and 10 signifying worst pain imaginable\]. This level of pain allows comparability of the study results with the majority of cLBP studies. Pain rated less than 3 is too mild to detect improvement.
. Men and women aged 18 years old and older. The investigators are not enrolling younger children as they are not part of the Intensive Pain Rehabilitation Therapy program.
. Eligibility will be assessed using the following questions: "(1) How long has back pain been an ongoing problem for you? and (2) How often has low-back pain been an ongoing problem for you over the past 6 months?" A response of greater than three months to question 1, and a response of "at least half the days in the past 6 months" to question 2 would meet the cLBP eligibility criterion.

Development and Feasibility of Mindfulness Based Pain Reduction

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Development and Feasibility of Mindfulness Based Pain Reduction

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria