Rage Against the Pain — RAP  

Chronic Low Back Pain Clinical Trial

Official title: Rage Against the Pain: An Alternative Yoga Program to Address Chronic Low Back Pain Among Veterans

Status Completed

Clinical Trial Summary

Low back pain is a leading cause of disability among US adults, and can drive opioid use and associated poor outcomes. The Veterans Health Administration (VA) considers low back pain a significant problem. Yoga is recommended as a front-line treatment for low back pain, however, Veteran participation in yoga is low. One potential barrier to adoption among Veterans may be their perceptions of yoga. In an effort to increase Veteran use of yoga, the investigators will develop and test an alternative yoga program that may better meet Veteran preferences and interests. The investigators call this yoga program, Rage Against the Pain (RAP) 'High Intensity Stretching'. The RAP program will promote yoga as less of a meditative, introspective activity done to quiet calming music and more of an expressive, active practice set to music commonly enjoyed among many Veterans (e.g., rock, metal). The goal of this pilot study is to develop and evaluate the RAP program, including Veteran perceptions of and experiences with the program and how it may impact yoga participation, among Veterans with chronic low back pain.

Clinical Trial Description

Background: Low back pain is a leading cause of disability among US adults, and can drive opioid use and associated adverse outcomes. VA considers low back pain a significant problem and is highly motivated to take action to improve Veteran engagement in pain care (including complementary and integrative health (CIH) programs). Yoga is recommended as a front-line treatment for low back pain, however, yoga adoption among Veterans is low. One potential barrier to adoption among Veterans may be their perceptions of yoga, which for some, encompass long-held but often inaccurate beliefs of what engaging in yoga entails and how their participation will be viewed by others. To facilitate uptake and sustained use of yoga, the investigators propose to offer Veterans a different yoga experience that imparts the same pain management benefits but may better align with their preferences and resonate more with their interests. The investigators call this yoga program, Rage Against the Pain (RAP) 'High Intensity Stretching'.

Significance/Impact: If this study finds that RAP is feasible and acceptable to Veterans who experience chronic low back pain, it will provide an innovative approach to address a top priority of the VA - using CIH programs for pain management and opioid use reduction. The long-term goal is to develop a scalable and sustainable alternative yoga program to help Veterans with chronic pain who may not find other available pain management options to be appealing or effective.

Innovation: The investigators' proposed RAP program promotes yoga as less of a meditative, introspective activity done to quiet calming music and more of an expressive, active practice set to music commonly enjoyed among many Veterans (e.g., rock, metal). The development of RAP (and the program name) reflects direct Veteran feedback, and was inspired by "rage yoga." The investigators will draw upon and tailor the aspects of rage yoga that make the most sense for Veteran health needs, adopting the beneficial aspects of the concept (e.g., traditional yoga poses, alternative music, outward self-expression).

Specific Aims: The overall goal is to develop and evaluate the RAP program, intended to improve Veteran participation in yoga and by extension, outcomes among Veterans with chronic low back pain. Specific Aims are to: (1) Develop the RAP program, which will encompass finalizing the program curriculum, including music play-lists, cues for self-expression, and sets of yoga movements known to alleviate low back pain; (2) Examine the feasibility and acceptability of offering RAP for Veterans with chronic low back pain, and; (3) Gather preliminary data to provide the foundation for process, sample size and power considerations for a future clinical trial to examine the effectiveness of RAP on Veterans' outcomes and medication use.

Methodology: Veterans who experience chronic low back pain will be invited to participate; eligible participants will be randomized into RAP or a Hatha yoga program. Classes will be held once a week for 12 weeks. A comprehensive safety plan will be instituted. Program initiation and attrition will be tracked and compared between groups. Baseline and follow-up data on outcomes (pain intensity; pain behavior; function; quality of life; sleep; depression; stress; use of pain medication and other pain management strategies) will be collected via survey. Veterans' experiences with and perceptions of the programs will be assessed through qualitative semi-structured interviews. Expected Results: The investigators anticipate RAP will be well-received by Veterans, and expect that participation in RAP will be greater (and attrition lower) than a traditional yoga program.

Implementation/Next Steps: The investigators intend to test the effectiveness of RAP in a larger multi-site trial and study issues associated with its implementation in these different settings. ;

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

• NCT number: NCT05103475
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Completion date: October 31, 2023