Trial Outcomes & Findings for Rage Against the Pain to Address Chronic Low Back Pain Among Veterans (NCT NCT05103475)
NCT ID: NCT05103475
Last Updated: 2024-09-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Baseline (following randomization)
Results posted on
2024-09-05
Participant Flow
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rage Against the Pain to Address Chronic Low Back Pain Among Veterans
Baseline characteristics by cohort
| Measure |
Rage Against the Pain (RAP)
n=18 Participants
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 (i.e., Yoga)
n=18 Participants
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.0 Years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
67.1 Years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
62.1 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Rage Against the Pain (RAP)
n=18 Participants
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 (i.e., Yoga)
n=18 Participants
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
|
|---|---|---|
|
Program Initiation (e.g., Reach)
|
16 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Rage Against the Pain (RAP)
n=18 Participants
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 (i.e., Yoga)
n=18 Participants
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
|
|---|---|---|
|
Program Participation (e.g., Sustained Engagement) - Average Number of Classes Attended
|
5.9 Average number of classes attended
Standard Deviation 4.9
|
4.5 Average number of classes attended
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Rage Against the Pain (RAP)
n=18 Participants
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 (i.e., Yoga)
n=18 Participants
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
|
|---|---|---|
|
Program Participation (e.g., Sustained Engagement) - Number of Veterans Who Attend Majority of Classes
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)Population: Please note that, for the control group, we had baseline data for 15 individuals and follow-up data for 11 individuals.
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.
Outcome measures
| Measure |
Rage Against the Pain (RAP)
n=11 Participants
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 (i.e., Yoga)
n=15 Participants
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
|
|---|---|---|
|
Pain Intensity
Baseline
|
5.1 score on a scale
Standard Deviation 1.8
|
6.5 score on a scale
Standard Deviation 1.6
|
|
Pain Intensity
Follow-Up
|
4.0 score on a scale
Standard Deviation 2.4
|
5.9 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Rage Against the Pain (RAP)
n=11 Participants
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 (i.e., Yoga)
n=15 Participants
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
|
|---|---|---|
|
Pain Interference
Baseline
|
63.0 t-score
Standard Deviation 6.3
|
64.6 t-score
Standard Deviation 4.4
|
|
Pain Interference
Follow-Up
|
59.2 t-score
Standard Deviation 6.3
|
63.8 t-score
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Rage Against the Pain (RAP)
n=11 Participants
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 (i.e., Yoga)
n=15 Participants
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
|
|---|---|---|
|
Back Pain-related Function
Baseline
|
10.1 score on a scale
Standard Deviation 6.4
|
14.1 score on a scale
Standard Deviation 5.3
|
|
Back Pain-related Function
Follow-Up
|
8.5 score on a scale
Standard Deviation 4.5
|
12.2 score on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Rage Against the Pain (RAP)
n=11 Participants
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 (i.e., Yoga)
n=15 Participants
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
|
|---|---|---|
|
Sleep
Baseline
|
14.5 score on a scale
Standard Deviation 7.7
|
15.9 score on a scale
Standard Deviation 6.8
|
|
Sleep
Follow-up
|
11.1 score on a scale
Standard Deviation 8.3
|
14.5 score on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Rage Against the Pain (RAP)
n=11 Participants
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 (i.e., Yoga)
n=15 Participants
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
|
|---|---|---|
|
Depression
Baseline
|
9.1 score on a scale
Standard Deviation 6.9
|
9.6 score on a scale
Standard Deviation 4.7
|
|
Depression
Follow-Up
|
7.6 score on a scale
Standard Deviation 6.0
|
8.2 score on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Rage Against the Pain (RAP)
n=11 Participants
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 (i.e., Yoga)
n=15 Participants
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
|
|---|---|---|
|
Stress
Baseline
|
8.2 score on a scale
Standard Deviation 2.9
|
7.4 score on a scale
Standard Deviation 2.1
|
|
Stress
Follow-Up
|
6.4 score on a scale
Standard Deviation 2.8
|
7.9 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Rage Against the Pain (RAP)
n=11 Participants
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 (i.e., Yoga)
n=15 Participants
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
|
|---|---|---|
|
Use of Other Pain Management Strategies
Baseline
|
1.6 Mean pain management activities reported
Standard Deviation 1.4
|
1.7 Mean pain management activities reported
Standard Deviation 1.6
|
|
Use of Other Pain Management Strategies
Follow-up
|
2.5 Mean pain management activities reported
Standard Deviation 1.0
|
2.9 Mean pain management activities reported
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)Population: These data are self-report and were gathered via separate survey questions; as such, n's may differ between questions.
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).
Outcome measures
| Measure |
Rage Against the Pain (RAP)
n=11 Participants
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 (i.e., Yoga)
n=14 Participants
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
|
|---|---|---|
|
Perceptions of the Program
Liked the program - extremely or quite a bit
|
9 Participants
|
6 Participants
|
|
Perceptions of the Program
Likelihood of participating in a program like it in the future - extremely or quite a bit
|
8 Participants
|
7 Participants
|
|
Perceptions of the Program
Helped manage back pain - extremely or quite a bit
|
8 Participants
|
2 Participants
|
|
Perceptions of the Program
Would recommend the program to another Veteran
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Rage Against the Pain (RAP)
n=11 Participants
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 (i.e., Yoga)
n=15 Participants
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
|
|---|---|---|
|
Pain Medication Use
Baseline
|
2.3 Average number of medications reported
Standard Deviation 2.1
|
2.5 Average number of medications reported
Standard Deviation 1.8
|
|
Pain Medication Use
Follow-Up
|
1.7 Average number of medications reported
Standard Deviation 1.7
|
2.4 Average number of medications reported
Standard Deviation 1.4
|
Adverse Events
Rage Against the Pain (RAP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control (i.e., Yoga)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place