Overcoming Pain Through Yoga in the Military (OPTYM)
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|ClinicalTrials.gov Identifier: NCT03504085|
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : May 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain Chronic Neck Pain||Other: Yoga: Active Hatha Other: Yoga: Restorative||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||We will be conducting a pilot RCT with two types of yoga interventions. A total of 50 participants will be randomized to attend either active Hatha yoga or restorative yoga. Enrollment will be conducted on a rolling basis.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Mind/Body Interventions for Chronic Low Back and Neck Pain in Military Personnel|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: Hatha Yoga
This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended.
Other: Yoga: Active Hatha
Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations
Other Name: Active
Active Comparator: Restorative Yoga
This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks.
Other: Yoga: Restorative
Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
Other Name: Non-Active
- Pain interference [ Time Frame: baseline, 12-weeks, 6-months ]Biref 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.
- PROMIS Pain Intensity SF [ Time Frame: baseline, 12-weeks, 6-months ]Self-Report measure of pain severity consisting of 3 items. This measure should take approximately 1 minute to complete. Item scores range from 1 to 5 (no pain to very severe pain, respectively) and the total score is the average of the three items.
- Roland-Morris Disability Questionnaire [ Time Frame: baseline, 12-weeks, 6-months ]Self-report measure consisting of 23 questions that ask about limitations experienced for a variety of daily activities.
- Neck Disability Index [ Time Frame: baseline, 12-weeks, 6-months ]Ten-item self-report measure to assess neck pain interference in daily life activities.
- CES-D 10 [ Time Frame: baseline, 12-weeks, 6-months ]Ten-item self-report measure on the frequency of mood symptoms. Scores greater than or equal to 10 indicate depression.
- Health Related Quality of Life (HRQOL) Short-form 12 (SF12) [ Time Frame: baseline, 12-weeks, 6-months ]12-Item self-report measure on individual's views about their health.
- AUDIT-C [ Time Frame: baseline, 12-weeks, 6-months ]The AUDIT-C is a 3-item alcohol screen that reliably identifies patients who are hazardous drinkers or have alcohol use disorders. The AUDIT-C is a modified version of the 10 question AUDIT instrument.
- The Fatigue Severity Scale (FSS) [ Time Frame: baseline, 12-weeks, 6-months ]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.
- Dimensions of Anger Reactions (DAR) [ Time Frame: baseline, 12-weeks, 6-months ]Developed by Forbes et al., The Dimensions of Anger Reactions questionnaire consists of 7 items and has demonstrated strong internal reliability and concurrent validity with other existing measures of anger.
- The Brief Resilience Scale (BRS) [ Time Frame: baseline, 12-weeks, 6-months ]The Brief Resilience Scale (BRS) assesses and individuals ability to recover from stress or trauma. The measure consists of six items and has good reliability and validity.
- Self Efficacy for Chronic Low Back Pain Scale [ Time Frame: baseline, 12-weeks, 6-months ]A 6-item self-report measure of an individual's confidence in performing certain activities. Items range from 1 (not at all confident) to 10 (totally confident).
- Physical Measures: Grip Strength [ Time Frame: baseline, 12-weeks, 6-months ]Grip strength will be measured with a hydraulic dynamometer. Two trials will be performed for each hand and the best performance will be taken for each side. The average of both hands is used for analysis.
- Physical Measures: Core Stabilization [ Time Frame: baseline, 12-weeks, 6-months ]Prone and supine bridge positions will assess core stabilization. Participants begin on their elbows in the prone position with shoulders, hips, and ankles aligned. The supine position is tested next, with knees flexed 90 degrees and pelvis raised from the floor with shoulders, hips, and knees aligned. Assessors record length of time (120 seconds max) that each position is held in proper form.
- Physical Measures: Balance [ Time Frame: baseline, 12-weeks, 6-months ]Balance will be measures performance on a one-leg stand on each side. Assessors record length of time (2 minutes max) that each one-leg stand is held in proper form.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504085
|Contact: Danielle Casteel, M.A.||858-622-1771 ext email@example.com|
|United States, California|
|UCSD's Health Services Research Center||Recruiting|
|San Diego, California, United States, 92121|
|Contact: Danielle Casteel, M.A. 858-622-1771 ext 7018 firstname.lastname@example.org|
|Principal Investigator: Erik Groessl, Ph.D.|
|Navy Medical Center San Diego||Recruiting|
|San Diego, California, United States, 92134|
|Contact: Danielle McPherson, MACPR 619-532-7889 email@example.com|
|Principal Investigator: Ian Fowler, MD|
|Principal Investigator:||Erik Groessl, Ph.D.||University of California, San Diego|
|Principal Investigator:||Ian Fowler, MD||Navy Medical Center, San Diego|