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
• Interventions: Behavioral: Acceptance and Commitment-based treatment; Other: Treatment as usual

• 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

Arm && Interventions

Group	Intervention	Description
Acceptance and Commitment-based treatment	Treatment as usual	Acceptance and Commitment-based (ACT) treatment including a face-to-face component administered during the patient stay in the rehabilitation unit and an online component including 4 ACT modules with an estimated duration of one month. The treatment is added to the Treatment as Usual provided in the rehabilitation unit.
Treatment as usual	Treatment as usual	Usual care including pharmacological therapy and exercise therapy, administered in the rehabilitation unit independently from the project.
Acceptance and Commitment-based treatment	Acceptance and Commitment-based treatment	Acceptance and Commitment-based (ACT) treatment including a face-to-face component administered during the patient stay in the rehabilitation unit and an online component including 4 ACT modules with an estimated duration of one month. The treatment is added to the Treatment as Usual provided in the rehabilitation unit.

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
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
Knee pain, stiffness and physical function	6 months	Subscales of the WOMAC questionnaire

Trial Locations

Locations (1)

Auxologico Mosè Bianchi; 🇮🇹 Milan, Italy