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

NCT05103475 | Completed Results

• 1 other identifier: PPO 19-362
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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'.

Conditions

Chronic Low Back Pain

Keywords

Chronic low back pain; Yoga; Veterans; Complementary and integrative health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Pain Intensity

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

• 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

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

• Sleep

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

• Depression

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

Study Arms (2)

Rage Against the Pain (RAP)

EXPERIMENTAL

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)

Control

ACTIVE COMPARATOR

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

Interventions

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).

Rage Against the Pain (RAP)

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.

Also known as: Yoga

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Results Point of Contact

• Title: Bella Etingen, PhD
• Organization: Veterans Health Administration

Bella.Etingen@va.gov

214-857-0240

Study Officials

• Bella Etingen, PhD MA BS

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Eligible patients will be randomly assigned to the RAP or control (Hatha yoga) group.

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: November 2, 2021
• Study Start: August 15, 2022
• Primary Completion: May 2, 2023
• Study Completion: October 31, 2023
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)