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Completed

NCT Number: NCT05103475

Rage Against the Pain 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'.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rage Against the Pain (RAP)

Behavioral

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).

Control

Behavioral

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

Primary outcomes

  1. Program Initiation (e.g., Reach)

    Time frame: Baseline (following randomization)

    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.

  2. Program Participation (e.g., Sustained Engagement) - Average Number of Classes Attended

    Time frame: 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) - average number of classes attended; this will be defined as the average number of classes Veterans attended for each respective program.

  3. Program Participation (e.g., Sustained Engagement) - Number of Veterans Who Attend Majority of Classes

    Time frame: 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; this will be defined as the number of Veterans who attended the majority (9/12) of classes.

Secondary outcomes

  1. Pain Intensity

    Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)

    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.

  2. Pain Interference

    Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)

    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.

  3. Back Pain-related Function

    Time frame: 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 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).

  4. Sleep

    Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)

    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.

  5. Depression

    Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)

    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.

  6. Stress

    Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)

    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).

  7. Use of Other Pain Management Strategies

    Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)

    The investigators will ask participants to self-report use of other pain management activities.

  8. Perceptions of the Program

    Time frame: Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)

    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).

  9. Pain Medication Use

    Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)

    The investigators will ask participants to self-report any pain medication use.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: RAP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2021
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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