Development and Feasibility of Mindfulness Based Pain Reduction

NCT04980612 | Active Not Recruiting Results DMC

• 2 other identifiers: # 21-343571R34AT010921
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low-back Pain

Keywords

pain; mindfullness; MBSR; Low Back; pain reduction; interoceptive awareness

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Change in average pain intensity in past week on Numeric Rating Scale \[0 to 10\] will be assessed by internet-based questionnaire using REDCap negative values indicate improvement.

  baseline, post 8-week intervention

Secondary Outcomes (1)

• Pain Interference

  baseline, post 8-week intervention

Other Outcomes (2)

• Interoceptive Awareness

  baseline, post 8-week intervention

• Changes in Insula Cortex Activation/Connectivity; Awaiting Separate Analysis

  baseline, post 8-week intervention.

Study Arms (2)

Group 1

EXPERIMENTAL

4 cohorts of 10 participants to MBPR (First 3 groups single-arm, final group of 10 randomly assigned to MBPR)

Behavioral: Mindfulness Based Pain Reduction

Group 2

ACTIVE COMPARATOR

The last 20 participants will be randomly assigned to MBSR or MBPR, which will results in a control group with \~10 participants undergoing MBSR

Behavioral: Mindfulness Based Stress Reduction

Interventions

Mindfulness Based Pain Reduction BEHAVIORAL

40 participants will participate in a MBPR program. It will be an optimized mindfulness program specifically designed for treating cLBP that we will develop and test in this project. The format is the same as MBSR: 8 weeks of weekly 2½-hour group sessions and a daylong retreat.

Group 1

Mindfulness Based Stress Reduction BEHAVIORAL

10 participants will participate in MBSR program. MBSR is a standardized and manualized 8-week program, delivered once a week in 2½-hour group sessions and a daylong retreat. It trains individuals in several mindfulness practices, e.g. focus on breath, varying degrees and directions of object orientation, open monitoring of awareness of intero- and exteroceptive stimuli and thoughts, de-reification (i.e. the notion that thoughts and perceptions are not always true to reality), and meta-awareness (i.e., awareness of thinking) in addition to focused attention.The program typically includes audio-recordings and a workbook for home practice and has shown benefits in patients with cLBP.

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Ability to speak English. We do not have the capacity, given the resources available in this proposal, to translate all course material and conduct groups into another language. The investiagtors have previously enrolled Hispanic participants into other studies who were fluent in English, and expect to do this in the proposed study.
• Owning a smart phone

You may not qualify if:

• Unable to provide informed consent.
• Spine related current or history of spine infection, spine tumor, vertebral fracture, cauda equina syndrome. Condition would increase heterogeneity of the sample.
• Blindness, severe vision problems, deafness, severe hearing problems, bipolar or manic depression and not taking medication, major depression, psychoses (major), a substance abuse condition, dementia, unable to get up and down from the floor. Condition might make it difficult to participate.
• Some other serious medical conditions that may alter key study outcomes, including untreated hypothyroidism, renal failure, and cirrhosis. Conditions that may alter key study outcomes.
• Involvement in a lawsuit related to their back. Complicated medico-legal issues that could lead to individuals having a financial incentive to not report improvement.
• Involved in Worker's Compensation claim.
• Pregnant, breast-feeding, or planning to get pregnant in the next 12 months or less than 3 months post-partum. Particular back problems than may be associated with pregnancy and delivery may confound study outcomes.
• Lack of stable housing or plan to move out of the area within the next 6 months.
• Received a steroid or botox injection in or near the spine in the last 3 months. This may alter key study outcomes.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of California San Francisco; Osher Center for Intgerative Medicine

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Wolf Mehling, MD
• Organization: University of California San Francisco

wolf.mehling@ucsf.edu

415

Study Officials

• Wolf E Mehling, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention and MBPR manual will be refined iteratively in 4 courses with 10 participants. The last of these 4 MBPR classes will be about 10 of 20 participants randomly assigned to either participate in standard MBSR or MBPR. The first part of the study is single-arm, the last randomized to assess acceptability of randomization.

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 28, 2021
• Study Start: December 14, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)