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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: Acceptance and Commitment-based treatment; Other: Treatment as usual

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20149
    • Recruiting
    • Auxologico Mosè Bianchi
    • Contact: Emanuele Giusti, PhD; Phone Number: 3498798942; Email: e.giusti@auxologico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Acceptance and Commitment-based treatment; The ACT-based group intervention includes four 1-hour group sessions over two weeks. The treatment manual was developed by the authors of this study following the ACT framework and adapting materials and resources from ACT-based treatments developed for other settings. The focus of the intervention is to provide patients with pain education specific for patients who underwent TKA and to promote psychological flexibility. Each session employs experiential exercises, including mindfulness meditation, and metaphors addressing the core components of ACT.; Other: Treatment as usual; Standard pharmacotherapy and physical exercise plan provided to all the patients in the rehabilitation unit.
Other: Treatment as usual; Usual care including pharmacological therapy and exercise therapy, administered in the rehabilitation unit independently from the project.	Other: Treatment as usual; Standard pharmacotherapy and physical exercise plan provided to all the patients in the rehabilitation unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days for pain disappearance	The first among five consecutive days with pain intensity <3 on a 0-10 Numeric Rating Scale	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Anticipated): March 15, 2024
• Study Completion (Anticipated): June 15, 2024

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
• Other Study ID Numbers: 03M902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset will be uploaded to an online repository
• IPD Sharing Time Frame: The dataset will be made available upon completion
• IPD Sharing Access Criteria: The dataset will be uploaded to an online repository
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No