Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03297905
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
Madigan Army Medical Center
Information provided by (Responsible Party):
Ardith Doorenbos, University of Washington

Brief Summary:
This study will (1) compare the effectiveness of standard rehabilitative pain care with complementary and integrative pain therapies; (2) identify subgroups of patients who do and do not respond to the intervention(s); (3) determine the most effective sequencing of the interventions; and (4) determine factors associated with treatment response that can be implemented to support clinical decision-making.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Complementary and Integrative Therapies Behavioral: Standard Rehabilitative Care Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential Multiple Assignment Randomized Trial (SMART)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : January 14, 2022
Estimated Study Completion Date : June 4, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Complementary and Integrative Therapies
Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction
Behavioral: Complementary and Integrative Therapies
Intervention time period is 3 - 6 weeks.

Active Comparator: Standard Rehabilitative Care
Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy
Behavioral: Standard Rehabilitative Care
Intervention time period is 3 - 6 weeks.




Primary Outcome Measures :
  1. Change from Baseline Pain Intensity [ Time Frame: 3 months ]
    Pain Intensity 10-pt Numeric Rating Scale

  2. Change from Baseline Pain Impact [ Time Frame: 3 months ]
    Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)


Secondary Outcome Measures :
  1. Depression [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    Patient Reported Outcome Measurement Information System

  2. Anxiety [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    Patient Reported Outcome Measurement Information System

  3. Emotional Distress - Anger [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    Patient Reported Outcome Measurement Information System

  4. Sleep Disturbance [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    Patient Reported Outcome Measurement Information System

  5. Fatigue [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    Patient Reported Outcome Measurement Information System

  6. PTSD [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    Primary Care PTSD Screen

  7. Patient Activation Measure [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    A 22-item survey that addresses four stages of patient activation: (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress. Patients are asked to agree or not to agree with each of the 22 items.

  8. Drug Use [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    Drug Use Questionnaire

  9. Pain Catastrophizing [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    Pain Catastrophizing Scale

  10. Kinesiophobia [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    Tampa Scale for Kinesiophobia

  11. Pain Self-Efficacy [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    Pain Self Efficacy Questionnaire

  12. Chronic Pain Acceptance [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    Chronic Pain Acceptance Questionnaire

  13. Functional Capacity [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    Roland-Morris Disability Questionnaire and Canadian Occupational Performance Measure

  14. Opioid Utilization [ Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months ]
    Opioid Utilization Screener

  15. Cortisol [ Time Frame: baseline, 6 weeks ]
    Salivary Cortisol

  16. Oxidative Stress [ Time Frame: baseline, 6 weeks ]
    Urine Sample

  17. Genomic DNA [ Time Frame: baseline ]
    Buccal Sample

  18. Army Physical Fitness Test (APFT) [ Time Frame: baseline, 6 weeks, 3 months, 6 months ]
    Passing scores of 60 on all 3 components (push-ups, sit-ups, 2-mile run) of the APFT will be operationalized as "force-readiness".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active duty service members
  • Neuromusculoskeletal or neuropathic pain ≥ 3-months duration
  • Pain of sufficient severity to bring about dysfunction in daily social, vocational, and/or interpersonal activities

Exclusion Criteria:

  • Major surgeries within past 6 months or planned within next 6 months
  • Unstable psychological disorders
  • Active substance use disorder

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): NCT03297905


Contacts
Layout table for location contacts
Contact: Linda Eaton 206-616-9396 lineaton@uw.edu

Locations
Layout table for location information
United States, Washington
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Diane Flynn, MD    206-616-0927    doorenbo@uw.edu   
Sponsors and Collaborators
University of Washington
Madigan Army Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Ardith Z Doorenbos, RN, PhD University of Washington
Layout table for additonal information
Responsible Party: Ardith Doorenbos, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03297905    
Other Study ID Numbers: STUDY00004220
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ardith Doorenbos, University of Washington:
Chronic Pain
Military
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations