NCT05769998

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-15
• Primary completion: 2024-03-15
• Completion: 2024-06-15
• First posted: 2023-03-15
• Last updated: 2023-03-15

Locations

1 site across 1 country: Italy