Knee Osteoarthritis
Conditions
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.
Interventions
BEHAVIORALAcceptance 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.
OTHERTreatment as usual
Standard pharmacotherapy and physical exercise plan provided to all the patients in the rehabilitation unit.
Sponsors
Istituto Auxologico Italiano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days for pain disappearance | 6 months | The first among five consecutive days with pain intensity \<3 on a 0-10 Numeric Rating Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of chronic pain | 6 months | WOMAC pain subscale \>4 |
| Pain intensity | 6 months | Pain intensity as measured by a 0-10 Numeric Rating Scale |
| Knee pain, stiffness and physical function | 6 months | Subscales of the WOMAC questionnaire |
| Physical and Mental Quality of Life | 6 months | Physical and Mental component scores on the SF-12 questionnaire |
Countries
Italy
Outcome results
None listed