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

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 and physical performance tests. Secondary outcomes include 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.

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)