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

Completed · Not applicable · Has a placebo group

Conditions studied: Lower Extremity Injury

In brief

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.

Key facts

Study ID

NCT03335657

Run by

Major Extremity Trauma Research Consortium

People needed

633

Starts

2018-07-18

Expected to finish

2021-07-18

Last updated by the study team

2025-09-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 18-60 yrs inclusive
• 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).
• Injury resulting from a moderate to high energy force (e.g. motor vehicle or motorcycle crash, fall > 10 ft, gun shot, blunt trauma)
• 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
• 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.

You may not qualify if…

• Non-English speaking
• 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
• 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
• Patients with major amputations of the upper or lower extremities (great toe, thumb, or proximal to the wrist or ankle)
• Patients who require a Legally Authorized Representative (as defined by an inability to answer the "Evaluation of Give Consent" questions)
• Patients non-ambulatory pre-injury or due to an associated spinal cord injury
• History of dementia or Alzheimer's disease based on medical record or patient self-report
• 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
• Presence of schizophrenia or other psychotic disorder based on medical record or patient self-report
• Current alcohol and/or drug addiction based on medical record or patient self-report
• Severe problems with maintaining follow-up expected (e.g. patients who are incarcerated or homeless)

Where it is running

• 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

Full record on ClinicalTrials.gov

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