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

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PROJECT SUMMARY/ABSTRACT 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 2½- 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.