Improving ACL Reconstruction Outcomes: CBPT

ACL Injury Clinical Trial

Official title:

Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243162
• Other study ID #: 161927
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: April 17, 2020

Study information

• Verified date: May 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 17, 2020
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL - Anterior Cruciate Ligament Rupture
• ACL Injury
• ACL Sprain
• ACL Tear
• Anterior Cruciate Ligament Injuries
• Rupture

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Garfield Heights	Ohio
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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