Chronic Pain Clinical Trial
Official title:
Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
Verified date | October 2022 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 280 |
Est. completion date | December 31, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Madigan Army Medical Center | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Madigan Army Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Pain Intensity | Pain Intensity 10-pt Numeric Rating Scale | 3 months | |
Primary | Change from Baseline Pain Impact | Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS) | 3 months | |
Secondary | Depression | Patient Reported Outcome Measurement Information System | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | Anxiety | Patient Reported Outcome Measurement Information System | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | Emotional Distress - Anger | Patient Reported Outcome Measurement Information System | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | Sleep Disturbance | Patient Reported Outcome Measurement Information System | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | Fatigue | Patient Reported Outcome Measurement Information System | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | PTSD | Primary Care PTSD Screen | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | Patient Activation Measure | 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. | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | Drug Use | Drug Use Questionnaire | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | Pain Catastrophizing | Pain Catastrophizing Scale | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | Kinesiophobia | Tampa Scale for Kinesiophobia | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | Pain Self-Efficacy | Pain Self Efficacy Questionnaire | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | Chronic Pain Acceptance | Chronic Pain Acceptance Questionnaire | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | Functional Capacity | Roland-Morris Disability Questionnaire and Canadian Occupational Performance Measure | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | Opioid Utilization | Opioid Utilization Screener | baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months | |
Secondary | Cortisol | Salivary Cortisol | baseline, 6 weeks | |
Secondary | Oxidative Stress | Urine Sample | baseline, 6 weeks | |
Secondary | Genomic DNA | Buccal Sample | baseline | |
Secondary | Army Physical Fitness Test (APFT) | Passing scores of 60 on all 3 components (push-ups, sit-ups, 2-mile run) of the APFT will be operationalized as "force-readiness". | baseline, 6 weeks, 3 months, 6 months |
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