Improving Recovery After Orthopaedic Trauma: Cognitive-Behavioral Based Physical Therapy (CBPT)
- Conditions
- Lower Extremity Injury
- Registration Number
- NCT03335657
- Lead Sponsor
- Major Extremity Trauma Research Consortium
- Brief Summary
The goal of the CBPT study is to determine the efficacy of the CBPT program for improving outcomes in service members and civilians at-risk for poor outcomes following traumatic lower-extremity injury. Primary outcome is physical function measured through a patient-reported questionnaire and physical performance tests. Secondary outcomes include pain and general health. Tertiary outcome is return to work/duty.
- Detailed Description
Following extremity injury, referral (and direct access) to physical therapy (PT) is considered standard of care. And, while PT strategies are commonly impairment focused, clinicians across multiple subspecialties of physical therapy recognize the importance of addressing pain and pain-related psychosocial factors as strong predictors of chronic pain as well as long-term physical and psychological disability.
Cognitive-behavioral therapy (CBT) interventions have documented positive influence on psychosocial factors in patients with chronic pain. CBT-based self-management programs have also demonstrated improvement in patient outcomes and the adoption of a physically active lifestyle, as well as improvement in fear-avoidance beliefs and self-efficacy, in various populations with chronic conditions. These evidence-based CBT and self-management strategies provide the basis for the study intervention.
The proposed project will conduct a multi-center, randomized controlled trial to determine the efficacy of the CBPT program in patients at-risk for poor outcomes following traumatic lower-extremity injury. Central hypothesis is that delivery of CBPT by physical therapists over the telephone will improve outcomes, through reductions in pain catastrophizing and fear of movement and improvement in pain self-efficacy. The investigators propose a large, rigorous evaluation of the CBPT program in patients with lower extremity trauma with the goal of engaging civilians and service members in their own care and improving pain and functional outcomes.
Specific Aim 1 To determine the efficacy of the CBPT program for improving outcomes in service members and civilians at-risk for poor outcomes following traumatic lower-extremity injury. Primary outcome is physical function measured through a patient-reported questionnaire. Secondary outcomes include physical performance tests, pain and general health. Tertiary outcome is return to work/duty.
Specific Aim 2 To determine whether changes in the intermediary outcomes of pain catastrophizing, fear of movement, and self-efficacy at 6 months are associated with improvement in outcomes 12 months after hospital discharge.
Specific Aim 3 To determine whether subgroups of patients are more likely to benefit from the CBPT program.
Specific Aim 4 To examine the value of CBPT relative to Education using Markov decision-analysis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 633
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Physical Function- self-reported capability to carry out activities 12 months Physical Function measured through Patient Reported Outcome Measurement Information System (PROMIS)/ Physical Function (short form) domain to assess one's ability to carry out activities that require a combination of skills, often within a social context. This instrument has five response options ranging in value from one to five for each question. The total raw score is the sum of values of the response for each question The highest possible raw score is 40 which represents the worse outcome. The lowest possible score is 8 and it represents the better outcome.
- Secondary Outcome Measures
Name Time Method Physical Function-Leg Strength, Endurance, and Mobility 12 months Leg Strength, Endurance, and Mobility measured through the Sit to Stand Five Times
Physical Function- Gait Speed 12 months Gait Speed measured through 10-Meter Walk test. Each individual will have time scores
Pain_ self reported 12 months Pain measured through Patient Reported Outcome Measurement Information System (PROMIS)/ Pain Intensity (short form) Domain at 12-months following hospital discharge. This tool has five response options ranging in value from one to five for each question. The total raw score is the sum of values of the response for each question The highest possible raw score is 15 which represents the worse outcome. The lowest possible score is 3 and it represents the better outcome.
Physical Function- Mobility and Power 12 months Mobility and Power measured through the Timed Stair Ascent test. Each individual will have time scores based on performance. Higher scores represent worse outcomes.
General Health 12 months General Health measured through Patient Reported Outcome Measurement Information System (PROMIS)/ General Health Domain at 12-months following hospital discharge.This instrument has five response options ranging in value from one to five for each question. The total raw score is the sum of values of the response for each question The highest possible raw score is 50 which represents the better outcome. The lowest possible score is 10 and it represents the worse outcome.
Physical Function- Balance and Agility 12 months Balance and Agility measured through the Four Square Step test. Each individual will have time scores based on performance. Higher scores represent worse outcomes.
Trial Locations
- Locations (8)
Florida Orthopaedic Institute
🇺🇸Tampa, Florida, United States
Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
University of Maryland, R Adams Cowley Shock Trauma Center
🇺🇸Baltimore, Maryland, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
The University of Texas Health Science Center at Houston Medical School
🇺🇸Houston, Texas, United States
San Antonio Military Medical Center
🇺🇸San Antonio, Texas, United States
Florida Orthopaedic Institute🇺🇸Tampa, Florida, United States