The treatment of chronic low back pain (cLBP) remains a major public health concern. Medication is of limited value. Current guidelines recommend using non-pharmacologic approaches for cLBP, which include yoga, tai chi, Mindfulness-Based Stress Reduction (MBSR), and Cognitive-Behavioral Therapy (CBT). While these approaches have been shown to be beneficial, all current approaches have important limitations in efficacy. We hypothesize that these interventions can be strengthened to be more effective for cLBP. In response to the FOA PAR-18-417 for high-priority topics, this proposal focuses on modifying MBSR to develop an optimized program for cLBP, Mindfulness-Based Pain Reduction (MBPR). Based on recent advances in the understanding of the central processing of pain, we plan modifications in three closely related and potentially synergistic areas: (1) strengthening the skill development of interoceptive awareness to address chronic pain through focused attention in the specific region of pain; (2) emphasizing mindful movement that is optimized by using cLBP-specific yoga movements; (3) shifting some of the emphasis in didactic content toward a better understanding of chronic pain and its neurophysiology, incorporating elements of cognitive-behavioral therapy for pain and neurophysiological pain education. The format will be the same as MBSR: 8 weeks of weekly 2- hour group sessions and a daylong retreat, but with a smaller group size: 10 participants per class to allow for more individualized support. Key goals are to reduce avoidance, rumination, pain catastrophizing, and fear of movement. We have developed an initial outline of the intervention. To refine it, we will convene an international panel of behavioral and yoga therapists with expertise in chronic pain education and management to obtain expert advice on intervention optimization and produce a first draft of a MBPR manual. We will enroll 4 x 10 = 40 patients with cLBP into 4 consecutive MBPR classes to iteratively refine the manualized MBPR protocol through mixed-methods evaluations after each 8-week round of MBPR. We will assess feasibility and acceptability of the MBPR protocol by questionnaires, mobile technology to assess home use of MBPR practices, and qualitative interviews. We will assess feasibility and acceptability of randomization by recruiting 20 participants and randomizing them to standard MBSR (n ?10) or to the fourth MBPR class (total n ?10). Key pain outcomes will be assessed at baseline, 8 weeks and 6 months. To prepare for a larger clinical trial, we will also test and refine a smartphone platform to obtain an ecological momentary assessment measure of pain outcomes and assess adherence to meditation practices. This clinical feasibility trial will prepare for a large multi-center efficacy trial in cLBP patients comparing MBPR with MBSR. This holds promise not only to advance integrative health approaches to cLBP, but to other forms of chronic pain.

Public Health Relevance

Chronic low back pain is one of the most important causes of disability, for which Mindfulness-Based Stress Reduction (MBSR) and yoga are recommended, but have limitations in how well they work. This project is aimed at developing a modified version of MBSR that we believe will prove to be more effective for chronic low back pain. Following the initial protocol development informed by a panel of international experts, 4 x 10 = 40 participants will undergo 8-week Mindfulness-Based Pain Reduction (MBPR) classes that are iteratively improved through participant feedback, will emphasize interoceptive awareness, and include detailed pain education and yoga exercise targeting low back pain.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Planning Grant (R34)
Project #
1R34AT010921-01A1
Application #
10127532
Study Section
Special Emphasis Panel (ZAT1)
Program Officer
Mudd, Lanay Marie
Project Start
2020-12-15
Project End
2023-11-30
Budget Start
2020-12-15
Budget End
2021-11-30
Support Year
1
Fiscal Year
2021
Total Cost
Indirect Cost
Name
University of California San Francisco
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94143