An interventional study of Yoga: Active Hatha and Yoga: Restorative in Chronic Low Back Pain and Chronic Neck Pain, sponsored by University of California, San Diego. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-17.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Health services research
Our primary aim is to assess the feasibility of conducting yoga research among active-duty military personnel with Chronic Low Back Pain (CLBP) and/or Chronic Neck Pain (CNP). In addition, we will evaluate the yoga intervention preferences and refine an existing yoga intervention to address those needs. The study will prepare us for a R01 funded pragmatic clinical trial of yoga for CLBP and CNP in active-duty military.
In preparation for a full-scale study via a subsequent R01 proposal, our study objective is to examine the feasibility and acceptability of conducting a yoga RCT among active-duty military personnel with CLBP/CNP in military and community settings. The study will be conducted in two phases: Phase 1 (completed) involved obtaining IRB approval to conduct research in military settings, collecting qualitative data from stakeholders on attitudes and preferences for yoga interventions, and refining the existing Yoga for CLBP intervention for the needs of active-duty military and persons with CNP. Phase 2 will recruit and randomize 50 military personnel with CLBP or CNP to either active hatha or restorative yoga. Pain interference, pain severity, physical function, opioid medication use, and mental health outcomes are of primary interest. Mechanisms will also be studied.
The specific aims are as follows:
Aim 1: Evaluate and navigate barriers and facilitators for obtaining IRB approval to conduct randomized controlled intervention studies with active-duty military personnel.
Aim 2: Evaluate the acceptability of and preferences for yoga interventions among active-duty military personnel with CLBP/CNP.
Aim 3: Refine and modify the existing Yoga for CLBP intervention to address CNP, and the needs of active-duty military personnel.
Aim 4: Evaluate the feasibility of recruitment of active-duty military personnel with CLBP/CNP into a yoga RCT.
Aim 5: Evaluate the adherence of this population to the two yoga interventions. Aim 6: Obtain effect size estimates to inform power analyses for a full-scale RCT.
Accomplishing these aims will prepare us for an R01 proposal to study the efficacy of yoga for military personnel with CLBP/CNP in a full-scale randomized, controlled trial. To be successful and maximize the scientific knowledge obtained from an R01 study, it is crucial to first establish working relationships with military researchers, ensure that recruitment and randomized assignment are feasible, pilot test measurement strategies, and ensure that both interventions will be well-attended and have been optimally chosen.
2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's enrollment of 49 is below the median of 60 across 2,209 interventional studies indexed under Chronic Pain.
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Exclusion Criteria:
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.
Other: Yoga: Active Hatha
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.
Other: Yoga: Restorative
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
Also known as: Active
Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
Also known as: Non-Active
Pain Interference
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.
Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Roland-Morris Disability Questionnaire
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.
Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
BPI Pain Severity
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.
Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Neck Disability Index
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.
Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Health Related Quality of Life (HRQOL) Short-form 12 (SF12) - Physical
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.
Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
HRQOL - SF12 - Mental Health
Mental Component Score for the SF12 Scores are scaled to range from 0-100 with higher scores indicating better mental quality of life.
Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
The Fatigue Severity Scale (FSS)
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.
Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
CES-D 10
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.
Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
AUDIT-C
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.
Time frame: baseline, 12-weeks, 6-months
Dimensions of Anger Reactions (DAR)
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.
Time frame: baseline, 12-weeks, 6-months
The Brief Resilience Scale (BRS)
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.
Time frame: baseline, 12-weeks, 6-months
Self Efficacy for Chronic Low Back Pain Scale
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.
Time frame: baseline, 12-weeks, 6-months
Physical Measures: Grip Strength
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.
Time frame: baseline, 12-weeks, 6-months
Physical Measures: Core Stabilization
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.
Time frame: baseline, 12-weeks, 6-months
Physical Measures: Balance
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.
Time frame: baseline, 12-weeks, 6-months
PROMIS - Pain Intensity
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.
Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
| Milestone | Hatha Yoga | Restorative Yoga |
|---|---|---|
| Started | 24 | 25 |
| Completed | 21 | 21 |
| Not completed | 3 | 4 |
| Withdrew: Lost to follow-up | 3 | 4 |
| Milestone | Hatha Yoga | Restorative Yoga |
|---|---|---|
| Started | 24 | 25 |
| Completed | 19 | 20 |
| Not completed | 5 | 5 |
| Withdrew: Lost to follow-up | 5 | 5 |
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.
| score on a scale | Hatha Yoga | Restorative Yoga |
|---|---|---|
| Baseline | 4.2 ± 2.2 | 4.0 ± 2.4 |
| 12 weeks | 3.9 ± 2.4 | 3.2 ± 2.5 |
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.
| score on a scale | Hatha Yoga | Restorative Yoga |
|---|---|---|
| Baseline | 10.8 ± 5.2 | 10.0 ± 5.6 |
| 12 weeks | 10.1 ± 6.3 | 7.6 ± 6.1 |
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.
| score on a scale | Hatha Yoga | Restorative Yoga |
|---|---|---|
| Baseline | 4.7 ± 1.7 | 4.7 ± 1.8 |
| 12 weeks | 4.0 ± 2.3 | 3.7 ± 1.9 |
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.
| score on a scale | Hatha Yoga | Restorative Yoga |
|---|---|---|
| Baseline | 14.3 ± 9.3 | 12.1 ± 9.0 |
| 12 weeks | 14.0 ± 10.7 | 10.0 ± 8.9 |
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.
| score on a scale | Hatha Yoga | Restorative Yoga |
|---|---|---|
| Baseline | 33.1 ± 7.3 | 36.5 ± 10.5 |
| 12 weeks | 37.0 ± 8.1 | 39.2 ± 9.6 |
Mental Component Score for the SF12 Scores are scaled to range from 0-100 with higher scores indicating better mental quality of life.
| score on a scale | Hatha Yoga | Restorative Yoga |
|---|---|---|
| Baseline | 47.1 ± 11.6 | 49.5 ± 9.5 |
| 12 weeks | 45.2 ± 12.5 | 47.1 ± 10.6 |
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.
| score on a scale | Hatha Yoga | Restorative Yoga |
|---|---|---|
| Baseline | 4.0 ± 1.4 | 4.0 ± 1.5 |
| 12 weeks | 4.4 ± 1.6 | 3.8 ± 1.6 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| score on a scale | Hatha Yoga | Restorative Yoga |
|---|---|---|
| Baseline | 9.8 ± 1.7 | 9.5 ± 2.3 |
| 12 weeks | 9.0 ± 2.4 | 8.6 ± 2.5 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hatha Yoga | 0/24 (0%) | 0/24 (0%) | 2/24 (8.3%) |
| Restorative Yoga | 0/25 (0%) | 0/25 (0%) | 4/25 (16%) |
| Event | Hatha Yoga | Restorative Yoga |
|---|---|---|
| leg surgeryMusculoskeletal and connective tissue disorders | 1/24 | 0/25 |
| Broken foot or ankleMusculoskeletal and connective tissue disorders | 1/24 | 1/25 |
| Back surgeryMusculoskeletal and connective tissue disorders | 0/24 | 1/25 |
| Unspecified surgerySurgical and medical procedures | 0/24 | 1/25 |
| Shoulder injuryMusculoskeletal and connective tissue disorders | 0/24 | 1/25 |
| Age, Continuous(years) | Hatha Yoga | Restorative Yoga | Total |
|---|---|---|---|
| Mean | 34 ± 9.1 | 32 ± 8.1 | 33 ± 8.5 |
| Sex: Female, Male(Participants) | Hatha Yoga | Restorative Yoga | Total |
|---|---|---|---|
| Female | 8 | 12 | 20 |
| Male | 16 | 13 | 29 |
| Ethnicity (NIH/OMB)(Participants) | Hatha Yoga | Restorative Yoga | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 8 | 11 |
| Not Hispanic or Latino | 21 | 17 | 38 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Hatha Yoga | Restorative Yoga | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 4 | 3 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 7 | 10 |
| White | 16 | 15 | 31 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Hatha Yoga | Restorative Yoga | Total |
|---|---|---|---|
| United States | 24 | 25 | 49 |
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