Development and Improvement of an Acceptance and Commitment-based Treatment for the Prevention of Chronic Pain After Total Knee Arthroplasty

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis

• Registration Number: NCT05769998
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

Reducing the incidence of chronic post-surgical pain after Total Knee Arthroplasty (TKA) is paramount. NOPAIN, a technology-enhanced Acceptance and Commitment-based treatment, will be developed, tested and improved for this purpose. The feasibility of NOPAIN will be evaluated in a small sample of patients listed for TKA at the IRCCS Istituto Auxologico Italiano. Potential pre-surgical and post-surgical predictors of non-response to treatment will be measured and tested using a machine learning algorithm. The results of this study will be employed to improve the content of NOPAIN or for identification of criteria for patient selection. Finally, a randomized controlled clinical trial will be performed. Patients listed for TKA will be randomized to Treatment As Usual (TAU) or to NOPAIN+TAU. Primary outcome will be time to complete pain relief, secondary outcomes will include subjective and objective measurements of quality of life and functional recovery.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-15
• Status Verified: 2023-02
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-03
• Last Update Submitted: 2023-03-03
• Study First Posted: 2023-03-15
• Last Update Posted: 2023-03-15
• Primary Completion: 2024-03-15
• Study Completion: 2024-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• having an age between 18 and 80 years
• having a diagnosis of OA as determined by medical record review
• having undergone a Total Knee Arthroplasty

Exclusion Criteria

• Inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of days for pain disappearance	6 months	The first among five consecutive days with pain intensity \<3 on a 0-10 Numeric Rating Scale

Secondary Outcome Measures

Name	Time	Method
Presence of chronic pain	6 months	WOMAC pain subscale \>4
Knee pain, stiffness and physical function	6 months	Subscales of the WOMAC questionnaire
Pain intensity	6 months	Pain intensity as measured by a 0-10 Numeric Rating Scale
Physical and Mental Quality of Life	6 months	Physical and Mental component scores on the SF-12 questionnaire

Trial Locations

Locations (1)

Auxologico Mosè Bianchi; 🇮🇹 Milan, Italy