Development and Improvement of an Acceptance and Commitment-based Treatment for the Prevention of Chronic Pain After Total Knee Arthroplasty
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Istituto Auxologico Italiano
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Number of days for pain disappearance
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of days for pain disappearance
Time Frame: 6 months
The first among five consecutive days with pain intensity \<3 on a 0-10 Numeric Rating Scale
Secondary Outcomes
- Presence of chronic pain(6 months)
- Pain intensity(6 months)
- Physical and Mental Quality of Life(6 months)
- Knee pain, stiffness and physical function(6 months)