Improving ACL Reconstruction Outcomes: CBPT

Study Overview
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Brief Summary
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The overall objective of this study is to conduct a two-group randomized trial to examine the efficacy of cognitive-behavioral based physical therapy (CBPT) for improving knee function, return to sport, and quality of life outcomes in patients following ACL reconstruction (ACLR). The study consists of two treatment groups: telephone-based cognitive-behavioral based physical therapy for ACLR (CBPT-ACLR) and telephone-based Education. The central hypothesis is that the CBPT-ACLR participants relative to the Education group will demonstrate significantly greater improvement in postoperative outcomes at 12 months following surgery.

Official Title
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Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy

Conditions
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ACL Injury, ACL - Anterior Cruciate Ligament Rupture, ACL Sprain, ACL Tear

Intervention / Treatment
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* Behavioral: CBPT-ACLR
* Other: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking (due to feasibility of employing study personnel to deliver and assess the study intervention); 14 to 35 years of age (children 14 and older have skeletal maturity and adults 35 and younger are less likely to have symptoms of knee osteoarthritis); no previous surgery to either knee; time from injury to surgery 12 months or less; active participation in a sport on a weekly basis prior to injury Exclusion Criteria: bilateral simultaneous ACL reconstructions; revision ACLR; any concurrent ligament (MCL, LCL, or PCL) surgical procedures; concurrent osteotomies or meniscus transplantations; surgery secondary to trauma, tumor, or infection; having workman's compensation insurance for surgery; on active military duty; medical history of schizophrenia or other psychotic disorder; and unable to provide stable address and access to a telephone

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBPT-ACLR<br>CBPT-ACLR program consisting of weekly phone calls. | Behavioral: CBPT-ACLR<br>* The CBPT-ACLR program focuses on improving sports function and return to sport. CBPT-ACLR sessions cover realistic expectations, relaxation strategies, problem-solving training, cognitive restructuring, and behavioral self-management (i.e., graded activity, goal setting, managing setbacks and symptom management plans). Each session builds upon the content of the previous session using an action plan and weekly homework is personally tailored based on patient goals. The program consists of one preoperative telephone session and six postoperative telephone sessions with a physical therapist. Each patient randomized into the CBPT-ACLR program will receive a manual to follow along with the study therapist.<br>|
| Active Comparator: Education<br>Education program consisting of weekly phone calls. | Other: Education<br>* The education program focuses on postoperative ACLR recovery. Sessions address benefits of physical therapy, proper biomechanics during sports and other functional activity, importance of early exercise after surgery, and ways to promote healing. Education on stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury are also provided. The Education program is matched to the CBPT-ACLR treatment in terms of session frequency, length and contact with the study therapist. Each patient randomized into the Education program will receive a manual to follow along with the study therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale | knee function relating to sport/recreation | Up to 12 months after ACLR surgery | 
| Marx Activity Rating Scale | The Marx Activity Rating Scale measures knee function relating to running, cutting, decelerating, and pivoting. | Up to 12 months after ACLR surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Patient Outcome for Return to Sports (SPORTS) | The SPORTS score measures 1) ability to perform the same sport with the same level of effort, 2) ability to reach the same level of performance, and 3) ability to perform with no pain or in spite of the pain. | Up to 12 months after ACLR surgery | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale | knee function relating to quality of life | Up to 12 months after ACLR surgery | 
| EQ-5D | The EQ-5D is used to measure non-disease-specific quality of life and calculate cost-effectiveness. | Up to 12 months after ACLR surgery |