CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 52 enrolled
Drug / intervention
Mindfulness Based Pain Reduction +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04980612
NCT04980612N/AActive

Feasibility Clinical Trial of Integrated Mind-Body Therapy for Chronic Low Back Pain

University of California, San Francisco·interventional·Posted Jul 28, 2021·Updated Apr 10, 2025

In Brief

A clinical study evaluating Mindfulness Based Pain Reduction and Mindfulness Based Stress Reduction for Chronic Low-back Pain. Active but no longer recruiting, targeting 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/AActiveOverdue
20222023202420252026
First PostedJul 28, 2021
Enrollment StartDec 14, 2021
Primary CompletionDec 1, 2023
Study CompletionDec 1, 2025
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.9 years ago

Interventions

Mindfulness Based Pain Reductionbehavioral

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.

Mindfulness Based Stress Reductionbehavioral

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.