Trial Outcomes & Findings for Overcoming Pain Through Yoga in the Military (NCT NCT03504085)

NCT ID: NCT03504085

Last Updated: 2023-02-17

Results Overview

Brief Pain Inventory (BPI) : Self-Report measure of pain interference and pain severity consisting of 14 items. The measure includes front and back body diagrams to describe areas of pain, four pain severity items and seven pain interference items rated on 0-10 scales, and one question about percentage of pain relief by analgesics. The pain interference score is the mean of the 7 interference items. The pain severity score is the mean of 4 severity items. Scale scores are the mean of relevant items. Thus, scores range from 0-10 with higher scores indicating more pain interference.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
• Results posted on: 2023-02-17

Participant Flow

Participant milestones

Measure	Hatha Yoga This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations	Restorative Yoga This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
End of Intervention - 12 Weeks STARTED	24	25
End of Intervention - 12 Weeks COMPLETED	21	21
End of Intervention - 12 Weeks NOT COMPLETED	3	4
Final Assessment - 6 Months STARTED	24	25
Final Assessment - 6 Months COMPLETED	19	20
Final Assessment - 6 Months NOT COMPLETED	5	5

Reasons for withdrawal

Measure	Hatha Yoga This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations	Restorative Yoga This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
End of Intervention - 12 Weeks Lost to Follow-up	3	4
Final Assessment - 6 Months Lost to Follow-up	5	5

Baseline Characteristics

Overcoming Pain Through Yoga in the Military

Baseline characteristics by cohort

Measure	Hatha Yoga n=24 Participants This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations	Restorative Yoga n=25 Participants This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.	Total n=49 Participants Total of all reporting groups
Age, Continuous	34 years STANDARD_DEVIATION 9.1 • n=5 Participants	32 years STANDARD_DEVIATION 8.1 • n=7 Participants	33 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	17 Participants n=7 Participants	38 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 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	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	15 Participants n=7 Participants	31 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	25 participants n=7 Participants	49 participants n=5 Participants

PRIMARY outcome

Timeframe: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Population: Effect size

Brief Pain Inventory (BPI) : Self-Report measure of pain interference and pain severity consisting of 14 items. The measure includes front and back body diagrams to describe areas of pain, four pain severity items and seven pain interference items rated on 0-10 scales, and one question about percentage of pain relief by analgesics. The pain interference score is the mean of the 7 interference items. The pain severity score is the mean of 4 severity items.

Scale scores are the mean of relevant items. Thus, scores range from 0-10 with higher scores indicating more pain interference.

Outcome measures

Measure	Hatha Yoga n=21 Participants This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations	Restorative Yoga n=21 Participants This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
Pain Interference Baseline	4.2 score on a scale Standard Deviation 2.2	4.0 score on a scale Standard Deviation 2.4
Pain Interference 12 weeks	3.9 score on a scale Standard Deviation 2.4	3.2 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Population: effect sizes

Self-report measure consisting of 23 questions that ask about limitations experienced for a variety of daily activities.

Scale scores are the sum of items endorsed, thus scores range from 0-23 with higher scores indicating more back pain-related disability.

Outcome measures

Measure	Hatha Yoga n=21 Participants This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations	Restorative Yoga n=21 Participants This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
Roland-Morris Disability Questionnaire Baseline	10.8 score on a scale Standard Deviation 5.2	10.0 score on a scale Standard Deviation 5.6
Roland-Morris Disability Questionnaire 12 weeks	10.1 score on a scale Standard Deviation 6.3	7.6 score on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Population: effect sizes - Cohen's d

Brief Pain Inventory (BPI) : Self-Report measure of pain severity consisting of 4 items. The measure includes front and back body diagrams to describe areas of pain, four pain severity items and seven pain interference items rated on 0-10 scales, and one question about percentage of pain relief by analgesics. The pain severity score is the mean of 4 severity items.

Scale scores are the mean of relevant items. Thus, scores range from 0-10 with higher scores indicating greater pain severity.

Outcome measures

Measure	Hatha Yoga n=21 Participants This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations	Restorative Yoga n=21 Participants This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
BPI Pain Severity Baseline	4.7 score on a scale Standard Deviation 1.7	4.7 score on a scale Standard Deviation 1.8
BPI Pain Severity 12 weeks	4.0 score on a scale Standard Deviation 2.3	3.7 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Population: effect sizes

Ten-item self-report measure to assess neck pain interference in daily life activities.

Each of the 10 items is scored from 0 - 5. The items are summed and scores range from 0-50 with higher scores indicating greater disability due to neck pain.

Outcome measures

Measure	Hatha Yoga n=21 Participants This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations	Restorative Yoga n=21 Participants This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
Neck Disability Index Baseline	14.3 score on a scale Standard Deviation 9.3	12.1 score on a scale Standard Deviation 9.0
Neck Disability Index 12 weeks	14.0 score on a scale Standard Deviation 10.7	10.0 score on a scale Standard Deviation 8.9

OTHER_PRE_SPECIFIED outcome

Timeframe: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Population: effect sizes

12-Item self-report measure on individual's views about their physical health.

Scores are scaled to range from 0-100 with higher scores indicating better physical quality of life.

Outcome measures

Measure	Hatha Yoga n=21 Participants This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations	Restorative Yoga n=21 Participants This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
Health Related Quality of Life (HRQOL) Short-form 12 (SF12) - Physical Baseline	33.1 score on a scale Standard Deviation 7.3	36.5 score on a scale Standard Deviation 10.5
Health Related Quality of Life (HRQOL) Short-form 12 (SF12) - Physical 12 weeks	37.0 score on a scale Standard Deviation 8.1	39.2 score on a scale Standard Deviation 9.6

OTHER_PRE_SPECIFIED outcome

Timeframe: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Mental Component Score for the SF12

Scores are scaled to range from 0-100 with higher scores indicating better mental quality of life.

Outcome measures

Measure	Hatha Yoga n=21 Participants This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations	Restorative Yoga n=21 Participants This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
HRQOL - SF12 - Mental Health Baseline	47.1 score on a scale Standard Deviation 11.6	49.5 score on a scale Standard Deviation 9.5
HRQOL - SF12 - Mental Health 12 weeks	45.2 score on a scale Standard Deviation 12.5	47.1 score on a scale Standard Deviation 10.6

OTHER_PRE_SPECIFIED outcome

Timeframe: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Population: effect sizes

The Fatigue Severity Scale (FSS) assesses the impact and severity of fatigue with 9 items. A score of > 4.0 constitutes severe fatigue.The measure has good psychometrics for pain disorders.

This is a 9-item questionnaire with questions related to how fatigue interferes with certain activities and severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score indicate greater fatigue severity.

Outcome measures

Measure	Hatha Yoga n=21 Participants This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations	Restorative Yoga n=21 Participants This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
The Fatigue Severity Scale (FSS) Baseline	4.0 score on a scale Standard Deviation 1.4	4.0 score on a scale Standard Deviation 1.5
The Fatigue Severity Scale (FSS) 12 weeks	4.4 score on a scale Standard Deviation 1.6	3.8 score on a scale Standard Deviation 1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Ten-item self-report measure on the frequency of mood symptoms. Scores greater than or equal to 10 indicate depression.

The 10 items are rated on a Likert scale from 0-3. Thus the total score ranges from 0-30 with higher scores indicating more depression.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 12-weeks, 6-months

The AUDIT-C is a 3-item alcohol screen that reliably identifies patients who are hazardous drinkers or have alcohol use disorders. The AUDIT-C is a modified version of the 10 question AUDIT instrument.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 12-weeks, 6-months

Developed by Forbes et al., The Dimensions of Anger Reactions questionnaire consists of 7 items and has demonstrated strong internal reliability and concurrent validity with other existing measures of anger.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 12-weeks, 6-months

The Brief Resilience Scale (BRS) assesses and individuals ability to recover from stress or trauma. The measure consists of six items and has good reliability and validity.

The score is the mean of the 6 items, which are rated from 1 to 5. Scores range from 1-5.0 and higher scores indicate greater resilience.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 12-weeks, 6-months

A 6-item self-report measure of an individual's confidence in performing certain activities. Items range from 1 (not at all confident) to 10 (totally confident).

The score is the mean of the items and ranges from 1-10 with higher scores indicating greater self-efficacy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 12-weeks, 6-months

Grip strength will be measured with a hydraulic dynamometer. Two trials will be performed for each hand and the best performance will be taken for each side. The average of both hands is used for analysis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 12-weeks, 6-months

Prone and supine bridge positions will assess core stabilization. Participants begin on their elbows in the prone position with shoulders, hips, and ankles aligned. The supine position is tested next, with knees flexed 90 degrees and pelvis raised from the floor with shoulders, hips, and knees aligned. Assessors record length of time (120 seconds max) that each position is held in proper form.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 12-weeks, 6-months

Balance will be measures performance on a one-leg stand on each side. Assessors record length of time (2 minutes max) that each one-leg stand is held in proper form.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Population: effect sizes

PROMIS (Patient-Reported Outcomes Measurement Information System) measure - Pain Intensity

The PROMIS Pain Intensity instrument consists of three items with 5 response options ranging from 1 ("had no pain") to 5 ("very severe") addressing how much pain the person experiences now and in the past 7 days. The raw score is the sum of the three questions, with a minimum of 3 and a maximum score of 15, with higher scores indicating greater pain intensity.

Outcome measures

Measure	Hatha Yoga n=21 Participants This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations	Restorative Yoga n=21 Participants This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
PROMIS - Pain Intensity 12 weeks	9.0 score on a scale Standard Deviation 2.4	8.6 score on a scale Standard Deviation 2.5
PROMIS - Pain Intensity Baseline	9.8 score on a scale Standard Deviation 1.7	9.5 score on a scale Standard Deviation 2.3

Adverse Events

Hatha Yoga

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Restorative Yoga

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hatha Yoga n=24 participants at risk This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Yoga: Active Hatha: Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations	Restorative Yoga n=25 participants at risk This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Yoga: Restorative: Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
Musculoskeletal and connective tissue disorders leg surgery	4.2% 1/24 • Number of events 1 • 6 months	0.00% 0/25 • 6 months
Musculoskeletal and connective tissue disorders Broken foot or ankle	4.2% 1/24 • Number of events 1 • 6 months	4.0% 1/25 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders Back surgery	0.00% 0/24 • 6 months	4.0% 1/25 • Number of events 1 • 6 months
Surgical and medical procedures Unspecified surgery	0.00% 0/24 • 6 months	4.0% 1/25 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders Shoulder injury	0.00% 0/24 • 6 months	4.0% 1/25 • Number of events 1 • 6 months

Additional Information

Erik Groessl, PhD

UC San Diego

Phone: 858-642-6347

Email: egroessl@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place