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Clinical Trials/NCT03335657
NCT03335657
Completed
Not Applicable

Improving Recovery After Orthopaedic Trauma: Cognitive-Behavioral Based Physical Therapy (CBPT)

Major Extremity Trauma Research Consortium8 sites in 1 country633 target enrollmentJuly 18, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lower Extremity Injury
Sponsor
Major Extremity Trauma Research Consortium
Enrollment
633
Locations
8
Primary Endpoint
Physical Function- self-reported capability to carry out activities
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 18, 2018
End Date
July 18, 2021
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Major Extremity Trauma Research Consortium
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Physical Function- self-reported capability to carry out activities

Time Frame: 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 Outcomes

  • Pain_ self reported(12 months)
  • General Health(12 months)
  • Physical Function- Balance and Agility(12 months)
  • Physical Function- Mobility and Power(12 months)
  • Physical Function-Leg Strength, Endurance, and Mobility(12 months)
  • Physical Function- Gait Speed(12 months)

Study Sites (8)

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