Clinical trial NCT03335657: Improving Recovery After Orthopaedic Trauma: Cognitive-Behavioral Based Physical Therapy (CBPT)
Official title: Improving Recovery After Orthopaedic Trauma: Cognitive-Behavioral Based Physical Therapy (CBPT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Injury
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 633
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

1. Ages 18-60 yrs inclusive
2. Patients with at least one acute orthopaedic injury to the lower extremities or pelvis/acetabulum (determination based on information available at the time of enrollment).
3. Injury resulting from a moderate to high energy force (e.g. motor vehicle or motorcycle crash, fall \> 10 ft, gun shot, blunt trauma)
4. Patients receiving operative fixation for one or more acute orthopaedic injuries at a participating hospital. Patients should be recruited at the time of primary injury, not revision or complication surgery
5. Presence of psychosocial risk factors for poor outcomes (defined as a score greater than 30 on the Pain Catastrophizing Scale (PCS) or a score equal to or greater than 39 on the Tampa Scale for Kinesiophobia (TSK) or a score equal to or less than 40 on the Pain Self Efficacy Scale (PSES)). These risk factors will be identified between 2 and 8 weeks after hospital discharge.

Exclusion criteria:

1. Non-English speaking
2. Patients who are unable to start the program within 12 weeks of discharge from hospital because of multiple readmission, admission to a rehabilitation facility, or other extenuating circumstances
3. Patients with moderate or severe traumatic brain injury (TBI), as evidenced by intracranial hemorrhage present on admission CT. If no CT performed, patient assumed not to have moderate or severe TBI
4. Patients with major amputations of the upper or lower extremities (great toe, thumb, or proximal to the wrist or ankle)
5. Patients who require a Legally Authorized Representative (as defined by an inability to answer the "Evaluation of Give Consent" questions)
6. Patients non-ambulatory pre-injury or due to an associated spinal cord injury
7. History of dementia or Alzheimer's disease based on medical record or patient self-report
8. History of neurological disorder, disease or event, resulting in prior cognitive and/or physical impairment, such as prior TBI or stroke based on medical record or patient self-report
9. Presence of schizophrenia or other psychotic disorder based on medical record or patient self-report
10. Current alcohol and/or drug addiction based on medical record or patient self-report
11. Severe problems with maintaining follow-up expected (e.g. patients who are incarcerated or homeless)

Primary outcomes:
measure: Physical Function- self-reported capability to carry out activities
timeFrame: 12 months
Secondary outcomes:
measure: Pain_ self reported
timeFrame: 12 months
measure: General Health
timeFrame: 12 months
measure: Physical Function- Balance and Agility
timeFrame: 12 months
measure: Physical Function- Mobility and Power
timeFrame: 12 months
measure: Physical Function-Leg Strength, Endurance, and Mobility
timeFrame: 12 months
measure: Physical Function- Gait Speed
timeFrame: 12 months
Other outcomes:
measure: Return to work/duty
timeFrame: 6 months
Locations:
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland, R Adams Cowley Shock Trauma Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston Medical School
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
Study officials:
affiliation: Vanderbilt University Medical Center
name: Kristin Swygert, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Katherine Frey, PhD
role: STUDY_DIRECTOR
References:
citation: Archer KR, Davidson CA, Alkhoury D, Vanston SW, Moore TL, Deluca A, Betz JF, Thompson RE, Obremskey WT, Slobogean GP, Melton DH, Wilken JM, Karunakar MA, Rivera JC, Mir HR, McKinley TO, Frey KP, Castillo RC, Wegener ST; METRC. Cognitive-Behavioral-Based Physical Therapy for Improving Recovery After Traumatic Orthopaedic Lower Extremity Injury (CBPT-Trauma). J Orthop Trauma. 2022 Jan 1;36(Suppl 1):S1-S7. doi: 10.1097/BOT.0000000000002283.