Rage Against the Pain to Address Chronic Low Back Pain Am... | NCT05103475

Rage Against the Pain to Address Chronic Low Back Pain Am... | NCT05103475 | Trialant

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
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)

Contacts/Locations Module

Name	Affiliation	Role
Bella Etingen, PhD MA BS	Edward Hines Jr. VA Hospital, Hines, IL	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Edward Hines Jr. VA Hospital, Hines, IL		Hines	Illinois	60141-3030	United States

Arm/Group Information

ID	Title	Description
FG000	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).
FG001	Control (i.e., Yoga)	The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00018 subjects FG00118 subjects
COMPLETED	Because of the way that our primary outcomes are defined, all Veterans were included in primary outcome analyses. The definition we used for 'Completed' is the number of Veterans who completed a post-participation survey; please note that post-participation surveys were sent to all 36 Veterans who were randomized, including those who dropped out of yoga classes.	FG00011 subjects FG00115 subjects
NOT COMPLETED		FG0007 subjects FG0013 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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).

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous	Participant age at first intervention session.

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Count of Participants

Participants

Baseline (following randomization)

ID	Title	Description
OG000	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).

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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).

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Bella Etingen, PhD	Veterans Health Administration	214-857-0240		Bella.Etingen@va.gov

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 15, 2022	Apr 29, 2024	Prot_SAP_001.pdf
ICF	No	No	Yes	Informed Consent Form	Jan 13, 2023	Apr 29, 2024	ICF_002.pdf

Intervention Browse Module

ID	Term
D015013	Yoga

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026443	Spiritual Therapies

Sex: Female, Male

As documented in the VA Corporate Data Warehouse administrative data.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0013 BG0025
Male	BG00016 BG00115 BG00231

Ethnicity (NIH/OMB)

As documented in the VA Corporate Data Warehouse administrative data.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0007 BG0012 BG0029
Not Hispanic or Latino	BG00011 BG00116 BG00227
Unknown or Not Reported	BG0000 BG0010 BG0020

Race (NIH/OMB)

As documented in the VA Corporate Data Warehouse administrative data. Please note that we included 'Other' race with 'Unknown or Not Reported'.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020
Asian	BG0000 BG0010 BG0020
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG0008 BG0013 BG00211
White	BG0009 BG00114 BG00223
More than one race	BG0000 BG0010 BG0020
Unknown or Not Reported	BG0001 BG0011 BG0022

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact	The reported value represents the calculated p-value for the Fisher's Exact test.	1.0	The investigators used Fisher's exact due to small cell sizes.													Other	Please note that all data analyses were exploratory because this was feasibility pilot.

Primary

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.

Posted

Mean

Standard Deviation

Average number of classes attended

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

ID	Title	Description
OG000	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).
OG001	Control (i.e., Yoga)	The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.

Units	Counts
Participants	OG00018 OG00118

Title

Denominators

Categories

Title	Measurements
	OG0005.9± 4.9 OG0014.5± 3.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		0.35														Other	Please note that all data analyses were exploratory because this was feasibility pilot.

Primary

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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).
OG001	Control (i.e., Yoga)	The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.

Units	Counts
Participants	OG00018 OG00118

Title

Denominators

Categories

Title	Measurements
	OG0008 OG0013

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact		0.15	The investigators used Fisher's Exact due to small cell sizes.													Other	Please note that all data analyses were exploratory because this was feasibility pilot.

Secondary

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.

Please note that, for the control group, we had baseline data for 15 individuals and follow-up data for 11 individuals.

Posted

Mean

Standard Deviation

score on a scale

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

ID	Title	Description
OG000	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).
OG001	Control (i.e., Yoga)	The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.

Units	Counts
Participants	OG00011 OG00115

Title

Denominators

Categories

Baseline

- ParticipantsOG00011
- ParticipantsOG00115

Title	Measurements
	OG0005.1± 1.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001	Pre/post comparison for control group scores.	t-test, 2 sided		0.43														Other	Please note that all data analyses were exploratory because this was feasibility pilot.
OG000	Pre/post comparison for RAP group score.

Secondary

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.

Posted

Mean

Standard Deviation

t-score

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

ID	Title	Description
OG000	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).
OG001	Control (i.e., Yoga)	The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.

Units	Counts
Participants	OG00011 OG00115

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00063.0± 6.3 OG00164.6± 4.4

Follow-Up

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001	Pre/post comparison for control group.	t-test, 2 sided		0.70														Other	Please note that all data analyses were exploratory because this was feasibility pilot.
OG000	Pre/post comparison for RAP group.

Secondary

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).

Posted

Mean

Standard Deviation

score on a scale

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

ID	Title	Description
OG000	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).
OG001	Control (i.e., Yoga)	The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.

Units	Counts
Participants	OG00011 OG00115

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00010.1± 6.4 OG00114.1± 5.3

Follow-Up

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001	Pre/post comparison - control group.	t-test, 2 sided		0.37														Other	Please note that all data analyses were exploratory because this was feasibility pilot.
OG000	Pre/post comparison - RAP group.

Secondary

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.

Posted

Mean

Standard Deviation

score on a scale

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

ID	Title	Description
OG000	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).
OG001	Control (i.e., Yoga)	The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.

Units	Counts
Participants	OG00011 OG00115

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00014.5± 7.7 OG00115.9± 6.8

Follow-up

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001	Pre/post comparison - control group.	t-test, 2 sided		0.56														Other	Please note that all data analyses were exploratory because this was feasibility pilot.
OG000	Pre/post comparison - RAP group.

Secondary

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.

Posted

Mean

Standard Deviation

score on a scale

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

ID	Title	Description
OG000	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).
OG001	Control (i.e., Yoga)	The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.

Units	Counts
Participants	OG00011 OG00115

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0009.1± 6.9 OG0019.6± 4.7

Follow-Up

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001	Pre/post comparison - control group.	t-test, 2 sided		0.50														Other	Please note that all data analyses were exploratory because this was feasibility pilot.
OG000	Pre/post comparison - RAP group.

Secondary

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).

Posted

Mean

Standard Deviation

score on a scale

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

ID	Title	Description
OG000	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).
OG001	Control (i.e., Yoga)	The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.

Units	Counts
Participants	OG00011 OG00115

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0008.2± 2.9 OG0017.4± 2.1

Follow-Up

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001	Pre/post comparison - control group.	t-test, 2 sided		0.54														Other	Please note that all data analyses were exploratory because this was feasibility pilot.
OG000	Pre/post comparison - RAP group.

Secondary

Use of Other Pain Management Strategies

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

Posted

Mean

Standard Deviation

Mean pain management activities reported

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

ID	Title	Description
OG000	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).
OG001	Control (i.e., Yoga)	The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.

Units	Counts
Participants	OG00011 OG00115

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0001.6± 1.4 OG0011.7± 1.6

Follow-up

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001	Pre/post comparison - control group.	t-test, 2 sided		0.11														Other	Please note that all data analyses were exploratory because this was feasibility pilot.
OG000	Pre/post comparison - RAP group.

Secondary

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).

These data are self-report and were gathered via separate survey questions; as such, n's may differ between questions.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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).
OG001	Control (i.e., Yoga)	The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.

Units	Counts
Participants	OG00011 OG00114

Title

Denominators

Categories

Liked the program - extremely or quite a bit

- ParticipantsOG00010
- ParticipantsOG00113

Title	Measurements
	OG0009

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Likelihood to participate in a program like it in the future	Fisher Exact	The investigators used Fisher's Exact due to small cell sizes.	0.41														Other	Please note that all data analyses were exploratory because this was feasibility pilot.
OG000

Secondary

Pain Medication Use

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

Posted

Mean

Standard Deviation

Average number of medications reported

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

ID	Title	Description
OG000	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).
OG001	Control (i.e., Yoga)	The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.

Units	Counts
Participants	OG00011 OG00115

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0002.3± 2.1 OG0012.5± 1.8

Follow-Up

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001	Pre/post comparison - control group.	t-test, 2 sided		0.91														Other	Please note that all data analyses were exploratory because this was feasibility pilot.
OG000	Pre/post comparison - RAP group.