Rage Against the Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: Rage Against the Pain (RAP)
* Behavioral: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans will be eligible to participate in the study if they: currently receive primary care services at the Hines VA received a diagnosis associated with chronic low back pain in the previous 3 months Exclusion Criteria: Veterans will be ineligible to participate in the study if any of the following are true for them: they currently regularly participate in yoga they regularly participated in yoga in the previous 6 months their back pain is a symptom of a specific treatable or underlying disease/condition(s) ankylosing spondylitis active or recent malignancy fracture/spinal cord injury spinal infection) they are experiencing progressive neurological deficits they have any other condition which results in severe disability non-ambulatory hemiparesis severe cognitive deficits they have a diagnosis associated with psychosis they are currently experiencing issues around substance abuse (not including prescription opioids), as identified through ICD-10 codes associated with 'mental and behavioral disorders due to psychoactive substance use' recorded in the patient's medical record in the previous 3 months they do not plan to be living in the Chicagoland area for the duration of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients will be randomly assigned to RAP or treatment as usual (regular yoga routinely offered at the hospital, which at the investigators' facility is Hatha yoga).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rage Against the Pain (RAP)<br>The RAP program curriculum will mirror that of the Hatha Yoga classes, but will differ from this traditional yoga practice in a number of ways: (1) the classes will be set to rock/heavy metal music; (2) meditation will not be incorporated; (3) yoga terms will not be used to describe the poses/movements (rather, poses will be cued in plain descriptive English terms); (4) the culminating activity for the class will be called a 'cool down' (rather than the typical relaxation/meditation exercise used in yoga, referred to as savasana). | Behavioral: Rage Against the Pain (RAP)<br>* The RAP program curriculum will mirror that of the Hatha Yoga classes, but will differ from this traditional yoga practice in a number of ways: (1) the classes will be set to rock/heavy metal music; (2) meditation will not be incorporated; (3) yoga terms will not be used to describe the poses/movements (rather, poses will be cued in plain descriptive English terms); (4) the culminating activity for the class will be called a 'cool down' (rather than the typical relaxation/meditation exercise used in yoga, referred to as savasana).<br>|
| Active Comparator: Treatment as Usual (i.e., yoga)<br>The 'treatment as usual' class will be conducted in the style of the yoga classes currently being offered to Veterans at the Hines VA Hospital, which is a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them. | Behavioral: Treatment as Usual<br>* The 'treatment as usual' class will be conducted in the style of the yoga classes currently being offered to Veterans at the Hines VA Hospital, which is a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.<br>* Other names: Yoga;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program initiation (e.g., reach) | Program initiation (e.g., reach) will be defined as the number of individuals who start the RAP or Hatha yoga programs after being screened, deemed eligible for participation, and randomized to one or the other. | Baseline (following randomization) | 
| Program participation (e.g., sustained engagement) - average number of classes attended | Program participation (e.g., sustained engagement) - average number of classes attended; this will be defined as the average number of classes Veterans attended for each respective program. | Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished) | 
| Program participation (e.g., sustained engagement) - number of Veterans who attend majority of classes | Program participation (e.g., sustained engagement) - number of Veterans who attend majority of classes; this will be defined as the number of Veterans who attended the majority (9/12) of classes. | Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity will be measured using the Defense and Veterans Pain Rating Scale, a valid and reliable numeric rating scale that asks individuals to report the average intensity of their low back pain on a scale of 0 (no pain) to 10 (worst pain imaginable) for the previous 7 days. | Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished) | 
| Pain interference | Pain interference (how much the individual's pain has interfered with all aspects of their life in the prior 7 days) will be measured using the validated, reliable Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item pain interference short form. PROMIS scores are standardized to reflect the general adult US population, such that a mean score of 50 reflects average pain experience; t-scores range from 40.7-77, and higher scores indicate greater levels of pain interference. | Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished) | 
| Back pain-related function | Back pain-related function will be measured using the Roland-Morris Disability Questionnaire (RMDQ), a valid and reliable scale of physical disability resulting from chronic low back pain. The RMDQ asks individuals to read 24 items noting back pain-related functional impairments and mark those that describe them. All marked items are summed for a total score ranging from 0 (no impairment) to 24 (maximum impairment). | Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished) | 
| Sleep | Sleep will be measured using the Insomnia Severity Index, which is a valid and reliable 7-item scale that produces a composite score of an individual's level of sleep disturbance during the past 14 days. Item responses are added to obtain a total scale score (range: 0-28); greater scores indicate more disturbed sleep and cut-points are provided by the scale developers that map to levels of clinical severity of sleep disturbance. | Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished) | 
| Depression | Depression severity will be measured using the 8-item Patient Health Questionnaire (PHQ-8), a valid and reliable measure that assesses individual's depression severity by asking them to evaluate 8 items that reflect symptoms of depression and indicate how often they have experienced each in the prior two weeks on a scale of 0 to 3 (not at all - nearly every day). Scores range from 0 (no depression symptomology) to 24 (most severe symptomology); scores can also be classified into mild, moderate, moderately severe and severe categories using cut-scores defined by the scale developers. | Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished) | 
| Stress | Stress will be measured using the Perceived Stress Scale (PSS) - 4 Item, a valid and reliable measure of individual's perceptions of how stressful their life experiences are. The PSS is comprised of 4 questions and produces a composite score of perceived stress (range: 0-16; higher scores indicate higher perceptions of stress). | Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished) | 
| Use of other pain management strategies | The investigators will ask participants to self-report any pain medication use, as well as any use of other programs for pain management. | Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished) | 
| Perceptions of the program | The investigators will ask participants about their perceptions of the program (extent to which they liked it, would participate again, would recommend to a peer, felt it impacted their health and how). | Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished) | 
| Pain medication use | The investigators will ask participants to self-report any pain medication use. | Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic low back pain, Yoga, Veterans, Complementary and integrative health