Rage Against the Pain to Address Chronic Low Back Pain Among Veterans (RAP)

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

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'.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Behavioral: Rage Against the Pain (RAP); Behavioral: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Hines, Illinois, United States, 60141-3030
      • Edward Hines Jr. VA Hospital, Hines, IL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rage Against the Pain (RAP); The sets of body positions used in the RAP program will mirror those used in the Hatha Yoga classes, but the RAP program 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 body positions (rather, positions will be cued in plain descriptive English terms); (4) the culminating activity for the class will be called a 'cool down' (rather than the savasana exercise typically used in yoga practice).	Behavioral: Rage Against the Pain (RAP); The sets of body positions used in the RAP program will mirror those used in the Hatha Yoga classes, but the RAP program 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 body positions (rather, positions will be cued in plain descriptive English terms); (4) the culminating activity for the class will be called a 'cool down' (rather than the savasana exercise typically used in yoga practice).
Active Comparator: Control; The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.	Behavioral: Control; The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.; Other Names: Yoga

What is the study measuring?

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
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)
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 the population mean (with a standard deviation of 10), 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)
Use of Other Pain Management Strategies	The investigators will ask participants to self-report use of other pain management activities.	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)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Bella Etingen, PhD MA BS, Edward Hines Jr. VA Hospital, Hines, IL

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Yoga; Veterans; Chronic low back pain; Complementary and integrative health
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: PPO 19-362

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No