Rage Against the Pain to Address Chronic Low Back Pain Among Veterans

NCT ID: NCT05103475

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2023-10-31

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Rage Against the Pain (RAP)

Intervention Type: 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

The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Yoga

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bella Etingen, PhD MA BS

Role: PRINCIPAL_INVESTIGATOR

Edward Hines Jr. VA Hospital, Hines, IL

Locations

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PPO 19-362

Identifier Type: -

Identifier Source: org_study_id