Improving ACL Reconstruction Outcomes: CBPT

Vanderbilt University Medical Center

Status: Completed

Conditions: ACL Sprain; ACL Tear; ACL Injury; ACL - Anterior Cruciate Ligament Rupture

Treatments: Behavioral: CBPT-ACLR; Other: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT03243162

161927

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 14 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

CBPT-ACLR

Experimental group

Description:

CBPT-ACLR program consisting of weekly phone calls.

Treatment:

Behavioral: CBPT-ACLR

Education

Active Comparator group

Description:

Education program consisting of weekly phone calls.

Treatment:

Other: Education