Trial Outcomes & Findings for Yoga for Veterans With CLBP (NCT NCT02524158)

NCT ID: NCT02524158

Last Updated: 2018-10-10

Results Overview

The primary outcomes is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline and 12-weeks. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . 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: 152 participants
• Primary outcome timeframe: baseline to 12 weeks
• Results posted on: 2018-10-10

Participant Flow

Participant milestones

Measure	Yoga The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
12-weeks Assessment STARTED	76	76
12-weeks Assessment COMPLETED	57	63
12-weeks Assessment NOT COMPLETED	19	13
6-month Assessment STARTED	76	76
6-month Assessment COMPLETED	54	55
6-month Assessment NOT COMPLETED	22	21

Reasons for withdrawal

Measure	Yoga The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
12-weeks Assessment Withdrawal by Subject	1	1
12-weeks Assessment Lost to Follow-up	18	12
6-month Assessment Withdrawal by Subject	1	1
6-month Assessment Lost to Follow-up	21	20

Baseline Characteristics

Yoga for Veterans With CLBP

Baseline characteristics by cohort

Measure	Yoga n=75 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=75 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.	Total n=150 Participants Total of all reporting groups
Age, Continuous	53.3 years STANDARD_DEVIATION 12.7 • n=5 Participants	53.6 years STANDARD_DEVIATION 13.9 • n=7 Participants	53.4 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	56 Participants n=7 Participants	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=5 Participants	60 Participants n=7 Participants	120 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	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	6 Participants n=7 Participants	9 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	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	54 Participants n=7 Participants	104 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	4 Participants n=7 Participants	9 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	75 Participants n=5 Participants	75 Participants n=7 Participants	150 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 12 weeks

Population: Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.

The primary outcomes is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline and 12-weeks. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . 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 n=75 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=75 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Roland-Morris Disability Questionnaire	-2.05 units on a scale Interval -3.18 to 0.92	-1.29 units on a scale Interval -2.36 to -0.22

PRIMARY outcome

Timeframe: baseline to 6-months

Population: Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.

The primary outcome is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline, 12-weeks, and 6-months. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . 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 n=75 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=75 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Roland-Morris Disability Questionnaire	-3.37 units on a scale Interval -4.51 to -2.23	-0.89 units on a scale Interval -2.02 to 0.23

SECONDARY outcome

Timeframe: baseline to 12 weeks

Population: Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.

The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.

Outcome measures

Measure	Yoga n=75 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=75 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline in Pain Intensity - Brief Pain Inventory at 12 Weeks	-0.61 units on a scale Interval -0.94 to -0.28	0.04 units on a scale Interval -0.27 to 0.35

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.

The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.

Outcome measures

Measure	Yoga n=75 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=75 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline in Pain Intensity - Brief Pain Inventory at 6 Months	-0.44 units on a scale Interval -0.78 to -0.11	0.15 units on a scale Interval -0.18 to 0.47

SECONDARY outcome

Timeframe: baseline to 12 weeks

The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 7 interference items used a as a measure of pain interference. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.

Outcome measures

Measure	Yoga n=75 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=75 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline Pain Interference - Brief Pain Inventory at 12 Weeks	-0.85 units on a scale Standard Error 0.245	-0.21 units on a scale Standard Error 0.217

SECONDARY outcome

Timeframe: baseline to 12 weeks

Fatigue (absence of energy) will be measured with the Fatigue Severity Scale (FSS). The FSS is a self-administered instrument developed to assess the impact and severity of fatigue. It 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 or an average score ranging from 1.0-7.0. Higher scores reflect greater fatigue severity and less energy.

Outcome measures

Measure	Yoga n=57 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=62 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline - Fatigue Severity Scale (FSS) at 12 Weeks	-5.29 units on a scale Standard Error 1.532	0.82 units on a scale Standard Error 1.172

SECONDARY outcome

Timeframe: baseline to 12 weeks

Health-related quality of life will be measured using the Short-form 12 (SF12). Based on the longer SF-36, the SF-12 was developed with the objective of finding a short yet meaningful measure of generic HRQOL or global health status. The 12 items were selected from the SF-36 and tested through a series of stages. The PCS-12 and MCS-12 show similar levels of precision to the summary scores derived from the longer 36-item measure. PCS-12 and MCS-12 scores are transformed to a 0 to 100, with higher scores indicating better quality of life.

Outcome measures

Measure	Yoga n=57 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=63 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline - SF12 PCS at 12 Weeks	4.40 units on a scale Standard Error 1.042	0.58 units on a scale Standard Error 0.853

SECONDARY outcome

Timeframe: baseline to 12 weeks

Mental Component Scale - Health-related quality of life will be measured using the Short-form 12 (SF12). Based on the longer SF-36, the SF-12 was developed with the objective of finding a short yet meaningful measure of generic HRQOL or global health status. The 12 items were selected from the SF-36 and tested through a series of stages. The PCS-12 and MCS-12 show similar levels of precision to the summary scores derived from the longer 36-item measure. PCS-12 and MCS-12 scores are transformed to a 0 to 100, with higher scores indicating better quality of life.

Outcome measures

Measure	Yoga n=57 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=63 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline - SF12 MCS at 12 Weeks	-0.04 units on a scale Standard Error 1.024	-0.43 units on a scale Standard Error 0.772

SECONDARY outcome

Timeframe: baseline to 12 weeks

Population: Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.

The EQ5D is a preference-based measure of health-related quality of life. The measure produces a single score ranging from 0 (death) to 1.00 (optimal health). Scores can be integrated with time to calculate Quality Adjusted Life Years.

Outcome measures

Measure	Yoga n=59 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=61 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline - EuroQOL 5D (EQ5D) at 12 Weeks	0.077 units on a scale Interval 0.031 to 0.122	0.018 units on a scale Interval -0.023 to 0.06

SECONDARY outcome

Timeframe: baseline to 12 weeks

Population: Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.

Depression will be assessed using the Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Derived from the full CES-D, there are 10 items that ask about the frequency of mood symptoms, rated on a 4-point Likert scale ranging from 0 (Never) to 3 (All of the Time). Scores range from 0 to 30, and higher scores indicate greater depression. A number of items are reverse-scored and a score of 10 or greater is considered depressed. Normative data on people with assorted chronic illnesses are available for comparisons.

Outcome measures

Measure	Yoga n=56 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=62 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline - Center for Epidemiologic Studies Short Depression Scale (CES-D 10) at 12 Weeks	-1.6 units on a scale Standard Error 0.549	-0.63 units on a scale Standard Error 0.499

SECONDARY outcome

Timeframe: baseline to 12 weeks

Population: Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.

The Brief Anxiety Inventory (BAI) measures the severity of anxiety symptoms, particularly those that distinguish anxiety from depression. The BAI consists of 21 items, is self-administered and can be completed in 5 to 10 minutes. Items are scored on a scale of 0 to 3 and are summed to generate a total score. Scores range from 0 to 63, and higher scores indicate greater depression.

Outcome measures

Measure	Yoga n=55 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=55 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline - Brief Anxiety Inventory (BAI) at 12 Weeks	-1.69 units on a scale Standard Error 1.08	0.23 units on a scale Standard Error 0.67

SECONDARY outcome

Timeframe: baseline to 12 weeks

Population: Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.

The PSQI is a validated measure of sleep quality. The global PSQI score has a range of 0-21, with higher scores indicating worse sleep quality.

Outcome measures

Measure	Yoga n=55 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=61 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline - Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks	-1.56 units on a scale Standard Error 0.43	-0.082 units on a scale Standard Error 0.41

SECONDARY outcome

Timeframe: baseline to 12 weeks

Self-efficacy for controlling CLBP reflects levels of confidence in the ability to influence the intensity of back pain symptoms and the impact that CLBP has on daily life. The questions are based on self-efficacy items developed for the Medical Outcomes Study in mixed chronic diseases. The wording of the items has been adapted to be specific to CLBP. The measure consists of 6 items, rated on a 6-point Likert scale, with each item ranging from 0-10. The total score is the mean of the 6 items with higher scores indicating greater self-efficacy for managing CLBP.

Outcome measures

Measure	Yoga n=57 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=63 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline - Self-efficacy for Managing Low Back Pain at 12 Weeks	0.26 units on a scale Standard Error 0.27	-0.48 units on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: 12 weeks

Two indicators of the amount of yoga practiced by each participant will be used. Actual attendance of yoga sessions will be assessed using VA medical record data. Attendance can range from 0-24 sessions attended for those participants randomized to yoga. Self-reported practice of yoga at home will be assessed using a weekly participant yoga log. The self-report yoga log assesses whether they practiced yoga each day, the amount of minutes practiced, the use of instructions, the difficulty of poses, and the estimated level of physical activity or exertion.

Outcome measures

Measure	Yoga n=75 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Attendance/ Home Practice	12.28 sessions attended Standard Error 1.013	—

SECONDARY outcome

Timeframe: baseline to 12 weeks

Population: Only a subset agreed to assessment. Some declined if concerned about injury. Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.

Spinal Range of Motion (ROM) will be measured using a Saunders Digital Inclinometer, a portable device which isolates lumbar ROM. The device is placed along the spine and uses a precise optical angular scanner. Forward bend angle measures how far forward and downward a person can bend at the waist, from a fully erect and/or normal standing position. The value typically ranges from 0-180 degrees, with higher values indicating greater flexibility.

Outcome measures

Measure	Yoga n=44 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=49 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline - Range of Motion - Flexion at 12 Weeks	7.41 degrees flexion Standard Error 2.56	2.65 degrees flexion Standard Error 2.24

SECONDARY outcome

Timeframe: baseline to 12 weeks

Population: Some participants declined to participate because of injury concern. Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.

Grip strength in both hands of each participant will be measured using an adjustable, hydraulic grip strength dynamometer (Jamar Hydraulic Hand Dynamometer). Three trials will be conducted for each hand. In cases of current pain flare-ups or recent procedures to a hand or wrist, the affected hand is not tested, and the result of the one other hand is used. If both hands are used the best performance of two trials will be selected for each side, and the average of the left and right hand will be used for analysis. The value measured is pounds of force exerted and typically ranges from 0 - 150 lbs, with higher numbers indicating greater grip strength.

Outcome measures

Measure	Yoga n=42 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=49 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline - Grip Strength at 12 Weeks	-0.30 pounds per sq inch Standard Error 1.59	0.62 pounds per sq inch Standard Error 1.17

SECONDARY outcome

Timeframe: baseline to 12 weeks

Population: Only a subset agreed to assessment. Some declined if concerned about injury. Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.

The Single Leg Stance (SLS) is a commonly used measure of both lower leg strength and balance. A total of four trials were conducted - left and right leg with both eyes open and eyes closed. Each trial will be timed from the moment the participant lifts one foot off the floor until the moment they need to place it on the floor again. If the participant is able to stand on one leg for 60 seconds the trial will be stopped and they will be asked to switch side. Values range from 0 - 60 seconds with greater values indicating better balance.

Outcome measures

Measure	Yoga n=43 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=49 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline - Lower Limb Strength and Balance - Eyes Open at 12 Weeks	6.21 seconds Standard Error 2.63	1.05 seconds Standard Error 1.34

SECONDARY outcome

Timeframe: baseline to 12 weeks

Population: Only a subset agreed to assessment. Some declined if concerned about injury. Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.

Time in seconds holding plank position on the elbows.

Outcome measures

Measure	Yoga n=40 Participants The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=44 Participants Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Change From Baseline - Lower Spine Stabilization - Core Strength at 12 Weeks	18.70 seconds Standard Error 4.15	10.50 seconds Standard Error 3.28

Adverse Events

Yoga

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Delayed Treatment Control - Usual Care

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 n=75 participants at risk The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.	Delayed Treatment Control - Usual Care n=75 participants at risk Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months.
Musculoskeletal and connective tissue disorders Increased back pain	2.7% 2/75 • Number of events 2	0.00% 0/75

Additional Information

Dr. Erik J. Groessl

VA San Diego

Phone: 858-552-8585

Email: erik.groessl@va.gov

Results disclosure agreements

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