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

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Acceptance and Commitment-based treatment
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance and Commitment-based treatment<br>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<br>* 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.<br>Other: Treatment as usual<br>* Standard pharmacotherapy and physical exercise plan provided to all the patients in the rehabilitation unit.<br>|
| Other: Treatment as usual<br>Usual care including pharmacological therapy and exercise therapy, administered in the rehabilitation unit independently from the project. | Other: Treatment as usual<br>* Standard pharmacotherapy and physical exercise plan provided to all the patients in the rehabilitation unit.<br>|

What is the study measuring?
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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 |