Mindfulness Based Pain Reduction — MBPR  

Chronic Low-back Pain Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

MBPR will be an optimized mindfulness program specifically designed for treating chronic low back pain (cLBP) that the investigators aim to develop and test in this project. 4 groups of 10 participants will receive MBPR consecutively to refine the MBPR curriculum. The format is the same as MBSR: 8 weeks of weekly 2½-hour group sessions and a daylong retreat. All sessions include training to enhance mindful interoceptive awareness through focused attention in the region of pain, the lower back.

A final group of 20 participants will be randomized to receive MBPR or MBSR. Total N=50 (40 MBPR; 10 MBSR). 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-recording and a workbook for home practice and has shown benefits in patients with cLBP.

This project also includes an ancillary brain imaging study designed to build on neuroscience reports of markedly decreased brain function and structure in the insular cortex (IC) of patients with cLBP. This project has the potential to reveal a potential central mechanism by which mind-body and acceptance-based approaches improve chronic pain conditions, e.g. cLBP. It may reveal a new paradigm for the treatment of cLBP with key importance and consequences for future behavioral intervention studies for pain. ;

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

• NCT number: NCT04980612
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 14, 2021
• Completion date: December 1, 2024