Improving ACL Reconstruction Outcomes: CBPT

• ClinicalTrials.gov Identifier: NCT03243162
• Recruitment Status: Completed
• First Posted: August 8, 2017
• Last Update Posted: May 20, 2020
• Sponsor: Vanderbilt University Medical Center
• Collaborator: The Cleveland Clinic
• Information provided by (Responsible Party): Kristin Archer, Vanderbilt University Medical Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
ACL Injury; ACL - Anterior Cruciate Ligament Rupture; ACL Sprain; ACL Tear	Behavioral: CBPT-ACLR; Other: Education	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy
• Actual Study Start Date: July 1, 2017
• Actual Primary Completion Date: February 18, 2020
• Actual Study Completion Date: April 17, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: CBPT-ACLR; CBPT-ACLR program consisting of weekly phone calls.	Behavioral: CBPT-ACLR; 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.
Active Comparator: Education; Education program consisting of weekly phone calls.	Other: Education; 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Subjective Patient Outcome for Return to Sports (SPORTS) [ Time Frame: Up to 12 months after ACLR surgery ]
   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.
2. Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale [ Time Frame: Up to 12 months after ACLR surgery ]
   knee function relating to quality of life
3. EQ-5D [ Time Frame: Up to 12 months after ACLR surgery ]
   The EQ-5D is used to measure non-disease-specific quality of life and calculate cost-effectiveness.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 35 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. English speaking (due to feasibility of employing study personnel to deliver and assess the study intervention);
2. 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);
3. no previous surgery to either knee;
4. time from injury to surgery 12 months or less;
5. active participation in a sport on a weekly basis prior to injury

Exclusion Criteria:

1. bilateral simultaneous ACL reconstructions;
2. revision ACLR;
3. any concurrent ligament (MCL, LCL, or PCL) surgical procedures;
4. concurrent osteotomies or meniscus transplantations;
5. surgery secondary to trauma, tumor, or infection;
6. having workman's compensation insurance for surgery;
7. on active military duty;
8. medical history of schizophrenia or other psychotic disorder; and
9. unable to provide stable address and access to a telephone

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic

Garfield Heights, Ohio, United States, 44125

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University Medical Center

The Cleveland Clinic

Investigators

• Principal Investigator: Kristin Archer, PhD, DPT; Vanderbilt University Medical Center

More Information

• Responsible Party: Kristin Archer, Associate Professor and Vice Chair of Research, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03243162
• Other Study ID Numbers: 161927
• First Posted: August 8, 2017
• Last Update Posted: May 20, 2020
• Last Verified: May 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Rupture; Anterior Cruciate Ligament Injuries; Wounds and Injuries; Knee Injuries; Leg Injuries