NCT04814992

Pre-op Cognitive Behavior Therapy to Decrease Chronic Post-Surgical Pain in TKA

Pre-op CBT to Reduce the Risk for Development of Chronic Post-surgical Pain in Patients Undergoing Total Knee Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

A significant number of patients develop chronic post-surgical pain (CPSP) following knee replacement surgery. Proposed is the testing of a novel computer-assisted behavioral intervention integrating motivational interviewing in the 4 weeks prior to surgery to address the risk factors for CPSP, with the expectation that severity of post-op pain and the incidence of CPSP will be reduced.

Detailed description

A significant number of patients develop chronic post-surgical pain following knee joint replacement surgery, and the risk factors for this problematic outcome have been identified. Proposed is the development and preliminary efficacy testing of a novel computer-assisted cognitive behavioral intervention integrating motivational interviewing delivered in the four weeks prior to surgery to address these risk factors, with the expectation that both the severity of post-operative pain and the subsequent incidence of chronic post-surgical pain will be reduced. In that chronic post-surgical pain brings with it diminished functionality and quality of life, ongoing opioid use, and direct patient costs, it is critical that interventions aimed at mitigating its development are implemented and evaluated in the clinical setting. In a sample of adults over the age of 21 with chronic pain undergoing a planned TKA, the objectives of this randomized clinical trial are to: 1. Add a motivational interviewing component to a validated computer-assisted CBT intervention for chronic pain (painTRAINER) to encourage opioid tapering, if applicable, and program adherence in the 4 weeks prior to surgery in patients scheduled to undergo a TKA. 2. Describe the efficacy of the 4-week targeted pre-operative CBT intervention in 45 TKA patients to decrease preoperative chronic pain severity, preoperative opioid consumption, and symptoms of depression, anxiety and pain catastrophizing prior to surgery in comparison to 45 TKA patients randomized to treatment-as-usual. 3. Describe the effects of a 4-week targeted pre-operative CBT intervention in 45 TKA patients on 48hr post-operative pain severity, and 3- and 6-month rates of CPSP in comparison to 45 TKA patients randomized to treatment-as-usual.

Conditions

• Chronic Post-Surgical Pain

Interventions

Type	Name	Description
BEHAVIORAL	Computer-Assisted Preoperative CBT Intervention (PAINTrainer)	Subjects will be asked to complete eight (8) 30- to 45-minute educational sessions during the 4 weeks prior to your surgery. In addition to the computer based training sessions, there is a motivational interviewing component that requires subjects to meet with a member of the study team weekly for a total of four (4) 30- to 45-minute meetings to help manage opioid medication use. It is expected that subject participation in this arm of the study will be a total of 12 hours over the course of the entire study.

Timeline

• Start date: 2020-10-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-03-24
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

4 sites across 1 country: United States