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Yoga for Veterans With CLBP

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Therapy for CLBP
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Yoga, Mind-Body Therapies, Chronic Low Back Pain, Military Veterans, VA patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a VA primary care provider
  • Diagnosis of chronic low back pain > 6 months
  • Willing to attend a yoga program or be assigned to delayed treatment with yoga
  • Willing to complete 4 assessments
  • English Literacy
  • Has not begun new pain treatments or medications in the past month
  • Willing to not change pain treatments (e.g., discontinue a treatment; increase medication dose) during the 12-week intervention period unless medically necessary

Exclusion Criteria:

  • back surgery within the last 12 months
  • back pain due to specific systemic problem (eg, lupus, scleroderma, fibromyalgia)
  • morbid obesity (BMI > 40)
  • Significant sciatica or nerve compression < 3 months or chronic lumbar radicular pain > 3 months
  • Unstable, serious coexisting medical illness (eg, CHF, cancer, COPD, morbid obesity; dementia)
  • Unstable, serious psychiatric illness (e.g., unmanaged psychosis, active substance dependence)
  • Insufficient data to rule out acute, metastatic disease, (unless primary care physician approves)
  • Attended or practiced yoga > 1x in the last 12 months
  • Positive Romberg test (with or without sensory neuropathy)

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga

Delayed Treatment Control - Usual Care

Arm Description

The yoga intervention will consist 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.

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.

Outcomes

Primary Outcome Measures

Roland-Morris Disability Questionnaire
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.
Roland-Morris Disability Questionnaire
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.

Secondary Outcome Measures

Change From Baseline in Pain Intensity - Brief Pain Inventory at 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 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.
Change From Baseline in Pain Intensity - Brief Pain Inventory at 6 Months
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.
Change From Baseline Pain Interference - Brief Pain Inventory at 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.
Change From Baseline - Fatigue Severity Scale (FSS) at 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.
Change From Baseline - SF12 PCS at 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.
Change From Baseline - SF12 MCS at 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.
Change From Baseline - EuroQOL 5D (EQ5D) at 12 Weeks
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.
Change From Baseline - Center for Epidemiologic Studies Short Depression Scale (CES-D 10) at 12 Weeks
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.
Change From Baseline - Brief Anxiety Inventory (BAI) at 12 Weeks
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.
Change From Baseline - Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks
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.
Change From Baseline - Self-efficacy for Managing Low Back Pain at 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.
Attendance/ Home Practice
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.
Change From Baseline - Range of Motion - Flexion at 12 Weeks
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.
Change From Baseline - Grip Strength at 12 Weeks
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.
Change From Baseline - Lower Limb Strength and Balance - Eyes Open at 12 Weeks
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.
Change From Baseline - Lower Spine Stabilization - Core Strength at 12 Weeks
Time in seconds holding plank position on the elbows.

Full Information

First Posted
August 10, 2015
Last Updated
September 11, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02524158
Brief Title
Yoga for Veterans With CLBP
Official Title
Yoga Therapy to Improve Function Among Veterans With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current treatment options have limited effectiveness. In addition to chronic pain, people with chronic low back pain experience increased disability, psychological symptoms such as depression, and reduced health-related quality of life. This randomized controlled study will examine the impact of yoga therapy for improving function and decreasing pain in VA patients with chronic low back pain. Although not every VA patient with chronic low back pain will choose to do yoga, it is an inexpensive treatment modality that is increasingly appealing to many VA patients. If yoga is effective, it could become an additional low-cost option that the VA can offer to better serve Veterans with chronic low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Yoga, Mind-Body Therapies, Chronic Low Back Pain, Military Veterans, VA patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
The yoga intervention will consist 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.
Arm Title
Delayed Treatment Control - Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Yoga Therapy for CLBP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Roland-Morris Disability Questionnaire
Description
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.
Time Frame
baseline to 12 weeks
Title
Roland-Morris Disability Questionnaire
Description
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.
Time Frame
baseline to 6-months
Secondary Outcome Measure Information:
Title
Change From Baseline in Pain Intensity - Brief Pain Inventory at 12 Weeks
Description
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.
Time Frame
baseline to 12 weeks
Title
Change From Baseline in Pain Intensity - Brief Pain Inventory at 6 Months
Description
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.
Time Frame
baseline to 6 months
Title
Change From Baseline Pain Interference - Brief Pain Inventory at 12 Weeks
Description
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.
Time Frame
baseline to 12 weeks
Title
Change From Baseline - Fatigue Severity Scale (FSS) at 12 Weeks
Description
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.
Time Frame
baseline to 12 weeks
Title
Change From Baseline - SF12 PCS at 12 Weeks
Description
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.
Time Frame
baseline to 12 weeks
Title
Change From Baseline - SF12 MCS at 12 Weeks
Description
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.
Time Frame
baseline to 12 weeks
Title
Change From Baseline - EuroQOL 5D (EQ5D) at 12 Weeks
Description
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.
Time Frame
baseline to 12 weeks
Title
Change From Baseline - Center for Epidemiologic Studies Short Depression Scale (CES-D 10) at 12 Weeks
Description
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.
Time Frame
baseline to 12 weeks
Title
Change From Baseline - Brief Anxiety Inventory (BAI) at 12 Weeks
Description
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.
Time Frame
baseline to 12 weeks
Title
Change From Baseline - Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks
Description
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.
Time Frame
baseline to 12 weeks
Title
Change From Baseline - Self-efficacy for Managing Low Back Pain at 12 Weeks
Description
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.
Time Frame
baseline to 12 weeks
Title
Attendance/ Home Practice
Description
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.
Time Frame
12 weeks
Title
Change From Baseline - Range of Motion - Flexion at 12 Weeks
Description
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.
Time Frame
baseline to 12 weeks
Title
Change From Baseline - Grip Strength at 12 Weeks
Description
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.
Time Frame
baseline to 12 weeks
Title
Change From Baseline - Lower Limb Strength and Balance - Eyes Open at 12 Weeks
Description
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.
Time Frame
baseline to 12 weeks
Title
Change From Baseline - Lower Spine Stabilization - Core Strength at 12 Weeks
Description
Time in seconds holding plank position on the elbows.
Time Frame
baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a VA primary care provider Diagnosis of chronic low back pain > 6 months Willing to attend a yoga program or be assigned to delayed treatment with yoga Willing to complete 4 assessments English Literacy Has not begun new pain treatments or medications in the past month Willing to not change pain treatments (e.g., discontinue a treatment; increase medication dose) during the 12-week intervention period unless medically necessary Exclusion Criteria: back surgery within the last 12 months back pain due to specific systemic problem (eg, lupus, scleroderma, fibromyalgia) morbid obesity (BMI > 40) Significant sciatica or nerve compression < 3 months or chronic lumbar radicular pain > 3 months Unstable, serious coexisting medical illness (eg, CHF, cancer, COPD, morbid obesity; dementia) Unstable, serious psychiatric illness (e.g., unmanaged psychosis, active substance dependence) Insufficient data to rule out acute, metastatic disease, (unless primary care physician approves) Attended or practiced yoga > 1x in the last 12 months Positive Romberg test (with or without sensory neuropathy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik J Groessl, PhD BA BS
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32826784
Citation
Groessl EJ, Liu L, Richard EL, Tally SR. Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans. Med Care. 2020 Sep;58 Suppl 2 9S:S142-S148. doi: 10.1097/MLR.0000000000001356.
Results Reference
derived
PubMed Identifier
28735778
Citation
Groessl EJ, Liu L, Chang DG, Wetherell JL, Bormann JE, Atkinson JH, Baxi S, Schmalzl L. Yoga for Military Veterans with Chronic Low Back Pain: A Randomized Clinical Trial. Am J Prev Med. 2017 Nov;53(5):599-608. doi: 10.1016/j.amepre.2017.05.019. Epub 2017 Jul 20.
Results Reference
derived

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Yoga for Veterans With CLBP

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