Trial Outcomes & Findings for Yoga and Mantram for Chronic Pain and PTSD (NCT NCT03816007)
NCT ID: NCT03816007
Last Updated: 2023-10-31
Results Overview
The RMDQ has 23 questions asking about limitations experienced with daily activities. The scale is reliable and well validated. It has been used in other yoga studies. Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Change between baseline and 12-weeks
Results posted on
2023-10-31
Participant Flow
Participant milestones
| Measure |
Yoga and Mantram Repetition
An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Yoga and Mantram Repetition: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
Relaxation/Health Education
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Veteran Calm: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
|---|---|---|
|
End of 12-week Intervention
STARTED
|
16
|
16
|
|
End of 12-week Intervention
COMPLETED
|
13
|
10
|
|
End of 12-week Intervention
NOT COMPLETED
|
3
|
6
|
|
Final Assessment at 18 Weeks.
STARTED
|
16
|
14
|
|
Final Assessment at 18 Weeks.
COMPLETED
|
12
|
10
|
|
Final Assessment at 18 Weeks.
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Yoga and Mantram Repetition
An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Yoga and Mantram Repetition: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
Relaxation/Health Education
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Veteran Calm: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
|---|---|---|
|
End of 12-week Intervention
Withdrawal by Subject
|
0
|
2
|
|
End of 12-week Intervention
Lost to Follow-up
|
3
|
4
|
|
Final Assessment at 18 Weeks.
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
Yoga and Mantram for Chronic Pain and PTSD
Baseline characteristics by cohort
| Measure |
Yoga and Mantram Repetition
n=16 Participants
An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Yoga and Mantram Repetition: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
Relaxation/Health Education
n=16 Participants
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Veteran Calm: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change between baseline and 12-weeksThe RMDQ has 23 questions asking about limitations experienced with daily activities. The scale is reliable and well validated. It has been used in other yoga studies. Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.
Outcome measures
| Measure |
Yoga and Mantram Repetition
n=13 Participants
An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Yoga and Mantram Repetition: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
Relaxation/Health Education
n=10 Participants
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Veteran Calm: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
|---|---|---|
|
Roland-Morris Disability Questionnaire (RMDQ)
|
13.6 score on a scale
Standard Deviation 4.4
|
14.3 score on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: change from baseline to 12 weeksBrief Pain Inventory Pain Severity - The total score is the mean of the 4 pain severity items. Scores range from 0-10 with higher scores indicating greater pain severity.
Outcome measures
| Measure |
Yoga and Mantram Repetition
n=13 Participants
An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Yoga and Mantram Repetition: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
Relaxation/Health Education
n=10 Participants
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Veteran Calm: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
|---|---|---|
|
BPI Pain Severity
|
-0.15 score on a scale
Standard Deviation 1.71
|
-1.15 score on a scale
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: Change between baseline and 12-weeksThe PCL-5 is a 20-item self-report measure assessing 20 DSM-5 symptoms of PTSD. Each question is rated on a scale from 0-4 and the total score ranges from 0-80 with higher scores indicating a greater severity of PTSD symptoms.
Outcome measures
| Measure |
Yoga and Mantram Repetition
n=13 Participants
An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Yoga and Mantram Repetition: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
Relaxation/Health Education
n=10 Participants
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Veteran Calm: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
|---|---|---|
|
Post-Traumatic Stress Disorder Checklist- Version 5 (PCL-5)
|
-4.23 score on a scale
Standard Deviation 13.8
|
-9.80 score on a scale
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: change from baseline to 12 weeksBrief Pain Inventory Pain Interference - The total score is the mean of the 7 pain interference items. Scores range from 0-10 with higher scores indicating greater pain interference.
Outcome measures
| Measure |
Yoga and Mantram Repetition
n=13 Participants
An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Yoga and Mantram Repetition: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
Relaxation/Health Education
n=10 Participants
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Veteran Calm: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
|---|---|---|
|
BPI Pain Interference
|
-0.73 score on a scale
Standard Deviation 2.28
|
-0.46 score on a scale
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: Change between baseline and 12-weeksInsomnia Severity Index is a 7-item instrument that assesses the impact of insomnia. Each question is rated on a scale from 0-4 and the total score ranges from 0-28 with higher scores indicating a greater severity of insomnia.
Outcome measures
| Measure |
Yoga and Mantram Repetition
n=13 Participants
An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Yoga and Mantram Repetition: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
Relaxation/Health Education
n=10 Participants
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Veteran Calm: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
|---|---|---|
|
Insomnia Severity Index (ISI)
|
-2.69 score on a scale
Standard Deviation 7.18
|
-0.30 score on a scale
Standard Deviation 3.92
|
SECONDARY outcome
Timeframe: Change between baseline and 12-weeksHealth-related Quality of Life will be measured with the EQ5D-3L. Scores range from 0 to 1.0 with higher scores indicating better quality of life.
Outcome measures
| Measure |
Yoga and Mantram Repetition
n=13 Participants
An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Yoga and Mantram Repetition: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
Relaxation/Health Education
n=10 Participants
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Veteran Calm: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
|---|---|---|
|
Quality of Life - EQ5D
|
0.02 units on a scale
Standard Deviation 0.22
|
0.10 units on a scale
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Change between baseline and 12-weeksAUDIT-C is a 3-item screen for problem drinking and will refer to alcohol use over the past 3-month period. The measure has questions on typical consumption and binge drinking frequency. Each question is rated on a scale from 0-4 and the total score ranges from 0-12 with higher scores indicating a greater likelihood of alcohol use problems.
Outcome measures
| Measure |
Yoga and Mantram Repetition
n=13 Participants
An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Yoga and Mantram Repetition: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
Relaxation/Health Education
n=10 Participants
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Veteran Calm: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
|---|---|---|
|
AUDIT-C
|
-0.62 score on a scale
Standard Deviation 0.87
|
-0.10 score on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: change from baseline to 12 weeksFatigue Severity Scale - The scale consists of 9 items describing the functional impact of fatigue on daily life rated on a scale from 1 (strongly disagree) to 7 (strongly agree) with the total fatigue score ranging from 9-63. Higher scores reflect greater fatigue severity and less energy.
Outcome measures
| Measure |
Yoga and Mantram Repetition
n=13 Participants
An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Yoga and Mantram Repetition: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
Relaxation/Health Education
n=10 Participants
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Veteran Calm: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
|---|---|---|
|
Fatigue
|
-7.38 score on a scale
Standard Deviation 9.38
|
-4.90 score on a scale
Standard Deviation 8.16
|
Adverse Events
Yoga and Mantram Repetition
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Relaxation/Health Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Yoga and Mantram Repetition
n=16 participants at risk
An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Yoga and Mantram Repetition: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
Relaxation/Health Education
n=16 participants at risk
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Veteran Calm: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
muscle and joint soreness
|
6.2%
1/16 • Number of events 1 • from baseline to 18-week follow-up assessment
|
0.00%
0/16 • from baseline to 18-week follow-up assessment
|
|
Musculoskeletal and connective tissue disorders
recurring back pain
|
6.2%
1/16 • Number of events 1 • from baseline to 18-week follow-up assessment
|
0.00%
0/16 • from baseline to 18-week follow-up assessment
|
|
Musculoskeletal and connective tissue disorders
ongoing numbness and tingling in arm
|
6.2%
1/16 • Number of events 1 • from baseline to 18-week follow-up assessment
|
0.00%
0/16 • from baseline to 18-week follow-up assessment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place