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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
210
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.
Standard pharmacotherapy and physical exercise plan provided to all the patients in the rehabilitation unit.
Auxologico Mosè Bianchi
Milan, Italy
RECRUITINGNumber of days for pain disappearance
The first among five consecutive days with pain intensity \<3 on a 0-10 Numeric Rating Scale
Time frame: 6 months
Presence of chronic pain
WOMAC pain subscale \>4
Time frame: 6 months
Pain intensity
Pain intensity as measured by a 0-10 Numeric Rating Scale
Time frame: 6 months
Knee pain, stiffness and physical function
Subscales of the WOMAC questionnaire
Time frame: 6 months
Physical and Mental Quality of Life
Physical and Mental component scores on the SF-12 questionnaire
Time frame: 6 months
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