Rage Against the Pain

Chronic Low Back Pain Clinical Trial

— RAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05103475
• Other study ID #: PPO 19-362
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 31, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Rage Against the Pain (RAP)
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).
• Treatment as Usual
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.

Locations

Country	Name	City	State
United States	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)