Clinical trial NCT05103475: Rage Against the Pain to Address Chronic Low Back Pain Among Veterans
Official title: Rage Against the Pain: An Alternative Yoga Program to Address Chronic Low Back Pain Among Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Chronic low back pain
Yoga
Veterans
Complementary and integrative health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-11-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomly assigned to the RAP or control (Hatha yoga) group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Chronic low back pain is a leading cause of disability among Veterans. Yoga is recommended as a front-line treatment option for chronic low back pain and is available across the VA healthcare system; however, despite yoga being the most widely adopted of VHA's Complementary and Integrative Health (CIH) therapies, Veteran participation in yoga still remains limited. Although it can be effective in managing pain, individuals cannot reap the benefits of yoga if they are unwilling to adopt it. One potential barrier to adoption of yoga among Veterans may be their perceptions of yoga, which for some, encompass long-held but perhaps inaccurate beliefs of what the practice entails and how their participation will be viewed by others. The goal of this study was to develop and evaluate an alternative-to-yoga program intended to improve Veteran participation and by extension, outcomes among Veterans with chronic low back pain. Based on Veteran input, we called this yoga program Rage Against the Pain (RAP) 'High Intensity Stretching'.

Detailed description: Background: Chronic low back pain is a leading cause of disability among Veterans. Yoga is recommended as a front-line treatment option for chronic low back pain and is available across the Veterans Health Administration (VHA) healthcare system; however, despite yoga being the most widely adopted of VHA's Complementary and Integrative Health (CIH) therapies, Veteran participation in yoga still remains limited. Although it can be effective in managing pain, individuals cannot reap the benefits of yoga if they are unwilling to adopt it. One potential barrier to adoption of yoga among Veterans may be their perceptions of yoga, which for some, encompass long-held but perhaps inaccurate beliefs of what the practice entails and how their participation will be viewed by others. The goal of this study was to to develop and evaluate an alternative-to-yoga program intended to improve Veteran participation and by extension, outcomes among Veterans with chronic low back pain. Based on Veteran input, we called this yoga program Rage Against the Pain (RAP) 'High Intensity Stretching'.

Significance/Impact: The RAP program is an innovative approach to address a top priority of the VHA - using CIH therapies for pain management. The long-term goal of this work is to develop a scalable and sustainable alternative-to-yoga program for Veterans with chronic pain.

Innovation: The RAP program comprises 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.

Specific Aims: The Specific Aims of this project were to: (1) Develop the RAP program, which encompassed finalizing the program curriculum, including music play-lists, cues for self-expression, and sets of body positions that may be beneficial for 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: We first developed the RAP program, including a home practice manual, sets of body positions, music playlists, and scripts to translate Sanskrit cuing to plain language. We then conducted a single-site pilot randomized controlled trial with two cohorts of 18 Veterans each (n=36). We randomized Veterans to the intervention (RAP) or control (Hatha yoga) group. Each cohort spanned 12 weekly one-hour sessions. We collected baseline (n=36) and follow-up (n=26) survey data and completed semi-structured interviews with a subset of survey respondents (n=20). Survey data were analyzed using bivariate comparisons. Interview transcripts were independently coded by two qualitative experts and analyzed using thematic coding techniques.

Implementation/Next Steps: We intend to conduct a larger multi-site trial of the RAP program to examine its effectiveness and issues associated with its implementation.

Eligibility criteria: 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), e.g.,

  * 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, e.g.,

  * 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
* they are pregnant at the time of screening

Primary outcomes:
measure: Program Initiation (e.g., Reach)
timeFrame: Baseline (following randomization)
measure: Program Participation (e.g., Sustained Engagement) - Average Number of Classes Attended
timeFrame: Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
measure: Program Participation (e.g., Sustained Engagement) - Number of Veterans Who Attend Majority of Classes
timeFrame: Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Secondary outcomes:
measure: Pain Intensity
timeFrame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
measure: Pain Interference
timeFrame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
measure: Back Pain-related Function
timeFrame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
measure: Sleep
timeFrame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
measure: Depression
timeFrame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
measure: Stress
timeFrame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
measure: Use of Other Pain Management Strategies
timeFrame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
measure: Perceptions of the Program
timeFrame: Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
measure: Pain Medication Use
timeFrame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
Study officials:
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
name: Bella Etingen, PhD MA BS
role: PRINCIPAL_INVESTIGATOR
References: