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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
Sponsor:
Collaborators:
United States Naval Medical Center, San Diego
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Erik Groessl, University of California, San Diego

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Chronic Neck Pain Other: Yoga: Active Hatha Other: Yoga: Restorative Not Applicable

Detailed Description:

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Neck Disability Index [ Time Frame: baseline, 12-weeks, 6-months ]
    Ten-item self-report measure to assess neck pain interference in daily life activities.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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.

  10. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of CLBP or CNP > 6 months
  • Willing to attend a yoga program for 12 weeks
  • Willing to complete 3 assessments
  • English literacy
  • Have had no changes in pain treatments in the past month
  • Willing to not change pain treatments during study unless medically necessary
  • Have not practiced yoga more than 2x in the last 12 months

Exclusion Criteria:

  • Back or neck surgery within the last year
  • Back or neck pain due to specific systemic problem (e.g., lupus, scoliosis)
  • Severe vertebral disk problems,
  • Persistent sciatica or nerve compression > 3 months
  • Coexisting chronic pain problem (e.g., migraine headaches, fibromyalgia)
  • Serious or unstable psychiatric illness (e.g., psychosis, mania, episode, or substance dependence)
  • Major coexisting medical illness (e.g., cancer, COPD, morbid obesity)
  • Positive Romberg test (with or without sensory neuropathy)

Information from the National Library of Medicine

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


Contacts
Contact: Danielle Casteel, M.A. 858-622-1771 ext 7018 dlcasteel@ucsd.edu

Locations
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    dlcasteel@ucsd.edu   
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    danielle.r.mcpherson.ctr@mail.mil   
Principal Investigator: Ian Fowler, MD         
Sponsors and Collaborators
University of California, San Diego
United States Naval Medical Center, San Diego
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Erik Groessl, Ph.D. University of California, San Diego
Principal Investigator: Ian Fowler, MD Navy Medical Center, San Diego

Responsible Party: Erik Groessl, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03504085     History of Changes
Other Study ID Numbers: R34AT009073-01 ( U.S. NIH Grant/Contract )
R34AT009073-01 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Erik Groessl, University of California, San Diego:
Chronic Low Back Pain
CLBP
Chronic Neck Pain
CNP
Chronic Pain
Military
Active Duty
Yoga
Mindbody

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms