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

Lower Extremity Injury Clinical Trial

— CBPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335657
• Other study ID #: W81XWH-16-2-0060
• Status: Completed
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: July 18, 2021

Study information

• Verified date: March 2023
• Source: Major Extremity Trauma Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 633
• Est. completion date: July 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lower Extremity Injury

Intervention

Other:
• CBPT
The CBPT program focuses on a patient-oriented cognitive-behavioral self-management approach to improve physical function and reduce pain, through reductions in pain catastrophizing and fear of movement and increases in self-efficacy.
• Education Treatment
Participants receiving the education control arm are receiving a placebo intervention to control for the attention of the interventionist. They will receive standardized educational material addressing recovery from orthopaedic trauma.

Locations

Country	Name	City	State
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	The University of Texas Health Science Center at Houston Medical School	Houston	Texas
United States	Methodist Hospital	Indianapolis	Indiana
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	San Antonio Military Medical Center	San Antonio	Texas
United States	Florida Orthopaedic Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Major Extremity Trauma Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Return to work/duty	Measured through the rate of return to work/duty 6 months post discharge	6 months
Primary	Physical Function- self-reported capability to carry out activities	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.	12 months
Secondary	Pain_ self reported	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.	12 months
Secondary	General Health	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.	12 months
Secondary	Physical Function- Balance and Agility	Balance and Agility measured through the Four Square Step test. Each individual will have time scores based on performance. Higher scores represent worse outcomes.	12 months
Secondary	Physical Function- Mobility and Power	Mobility and Power measured through the Timed Stair Ascent test. Each individual will have time scores based on performance. Higher scores represent worse outcomes.	12 months
Secondary	Physical Function-Leg Strength, Endurance, and Mobility	Leg Strength, Endurance, and Mobility measured through the Sit to Stand Five Times	12 months
Secondary	Physical Function- Gait Speed	Gait Speed measured through 10-Meter Walk test. Each individual will have time scores	12 months