Effectiveness of a Psychological Intervention in Patients Undergoing Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of a combined Pain Neuroscience Education (PNE) and Hypnosis (HyP) psychological intervention aiming at the control and prevention of pain and promotion of post-surgical recovery in patients undergoing Total Knee Arthroplasty

Detailed Description
-----------------
This is a prospective Randomized Controlled Trial (RCT), comparing an experimental group (EG), submitted to a PNE/HyP based psychological intervention, and a control group (CG), submitted to usual treatment and care. After recruitment and evaluation of inclusion/exclusion criteria, patients entering the study will sign the Informed Consent. Baseline evaluation is performed at 1 month pre-surgery and, afterwards, patients are randomly assigned to EG (PNE+Hyp plus usual care) or CG (usual care only). The EG will be submitted to 3 pre-surgical and 1 (or 2) post-surgical reinforcement sessions. At 1 month post-surgery, the intervention group will be subdivided and participants will be randomly assigned to receive a reinforcement session or no intervention at this point. The psychological intervention sessions are based on the educative principles of Pain Neuroscience Education and on Hypnosis strategies for the promotion of pain control, positive coping strategies and psychological variables. Patients will be evaluated on 6 moments: T0 - baseline, 1 month pre surgery; T1 - post intervention/24h before surgery; T2 - 72h post-surgery; T3 - 1 month post surgery; T4 - 6 months post surgery; T5 - 12 months post intervention. Patients will fill in self report measures and perform physiological evaluation to analyse relevant bio-markers (salivary cortisol and α-amylase) that are related to stress levels and SNS functioning and translate the impact of psychological interventions on physiological parameters.

Official Title
-----------------
Effectiveness of a Psychological Intervention for the Control and Prevention of Pain and for Surgical Recovery in Patients Undergoing Total Knee Arthroplasty: a Prospective Randomized Controlled Trial

Conditions
-----------------
Knee Arthroplasty, Total

Intervention / Treatment
-----------------
* Other: PNE+HyP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned unilateral total knee arthroplasty due to gonarthrosis Giving consent to participate Exclusion Criteria: Inability to write and read Cognitive deficit (assessed by MMSE) Revision TKA Bilateral TKA TKA for reasons other than gonarthrosis (fracture, malignancy or infection) Psychiatric or neurological deficit (e.g. Schizophrenia or Alzheimers') Diagnosis of rheumatoid arthritis, Psoriatic arthritis, Systemic lupus erythematosus, Anquilosant spondylitis or other severe disease Contralateral hip or knee arthroplasty in the previous 6 months Planned contralateral hip or knee arthroplasty in the next 6 months

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (PNE+HyP)<br>Patients in this group will have 3 pre-surgical + 1 (or 2) reinforcement sessions in adition to standard TKA care. These interventions are based on Pain Neuroscience Education and Hypnosis and delivered according to standardized scripts. | Other: PNE+HyP<br>* This is a combined PNE and Hypnosis psychological intervention. PNE is a cognitive based approach that highlights the biopsychosocial model of pain and focuses on neurophysiological and neurobiological processes and pain representation. Hypnosis aims at promoting pain control, increasing positive coping strategies, and targeting positive psychological variables.<br>|
| No Intervention: Control Group<br>No intervention / Standard care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity post-intervention as assessed by Numerical Rating Scale (NRS) and WOMAC |  | 24h before surgery | 
| Pain intensity 72h post-surgery as assessed by NRS |  | 72h post-surgery | 
| Pain intensity 1 month post-surgery as assessed by NRS and WOMAC |  | 1 month post-surgery | 
| Pain intensity 6 months post-surgery as assessed by NRS and WOMAC |  | 6 months post-surgery | 
| Pain intensity 12 months post-surgery as assessed by NRS and WOMAC |  | 12 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical functioning post-intervention as assessed by WOMAC |  | 24h before surgery | 
| Physical functioning 1 month post-surgery as assessed by WOMAC |  | 1 month post-surgery | 
| Physical functioning 6 months post-surgery as assessed by WOMAC |  | 6 months post-surgery | 
| Physical functioning 12 months post-surgery as assessed by WOMAC |  | 12 months post-surgery | 
| Pain knowledge post-intervention as assessed by the Neurophisiology of Pain Questionnaire (NPQ) |  | 24h before surgery | 
| Pain knowledge 1 month post-surgery as assessed by the NPQ |  | 1 month post-surgery | 
| Pain knowledge 6 months post-surgery as assessed by NPQ |  | 6 months post-surgery | 
| Pain knowledge 12 months post-surgery as assessed by NPQ |  | 12 months post-surgery | 
| Emotional distress post-intervention as assessed by the Hospital Anxiety and Depression Scale (HADS) |  | 24h before surgery | 
| Emotional distress 1 month post-surgery as assessed by HADS |  | 1 month post-surgery | 
| Emotional distress 6 months post-surgery as assessed by HADS |  | 6 months post-surgery | 
| Emotional distress 12 months post-surgery as assessed by HADS |  | 12 months post-surgery | 
| Optimism post-intervention as assessed by the Life Orientation Test (LOT-R) |  | 24h before surgery | 
| Optimism 1 month post-surgery as assessed by LOT |  | 1 month post-surgery | 
| Optimism 6 months post-surgery as assessed by LOT-R |  | 6 months post-surgery | 
| Optimism 12 months post-surgery as assessed LOT-R |  | 12 months post-surgery | 
| Pain coping strategies post-intervention as assessed by the Coping Strategies Questionnaire (CSQ) |  | 24h before surgery | 
| Pain coping strategies 1 month post-surgery as assessed by CSQ |  | 1 month post-surgery | 
| Pain coping strategies at 6 months post-surgery as assessed by CSQ |  | 6 months post-surgery | 
| Pain coping strategies at 12 months post-surgery as assessed by CSQ |  | 12 months post-surgery | 
| Hope post-intervention as assessed by the Portuguese Hope Scale (Escala Sobre a Esperança - ESE) |  | 24h before surgery | 
| Hope at 1 month post-surgery as assessed by ESE |  | 1 month post-surgery | 
| Hope at 6 months post-surgery as assessed by ESE |  | 6 months post-surgery | 
| Hope at 12 months post-surgery as assessed by ESE |  | 12 months post-surgery | 
| Self-Efficacy post-intervention as assessed by the Self-Efficacy Scale developed for this study (KSESS) |  | 24h before surgery | 
| Self-Efficacy at 1 month post-surgery as assessed by KSESS |  | 1 month post-surgery | 
| Self-Efficacy at 6 months post-surgery as assessed by KSESS |  | 6 months post-surgery | 
| Self-Efficacy at 12 months post-surgery as assessed by KSESS |  | 12 months post-surgery | 
| Salivary cortisol levels post-intervention |  | 24h before surgery | 
| Salivary cortisol levels 72h post-surgery |  | 72h post-surgery | 
| Salivary cortisol levels at 1 month post-surgery |  | 1 month post-surgery | 
| Salivary cortisol levels at 6 months post-surgery |  | 6 months post-surgery | 
| Salivary cortisol levels at 12 months post-surgery |  | 12 months post-surgery | 
| Salivary α-amylase levels post-intervention |  | 24h before surgery | 
| Salivary α-amylase levels 72h post-surgery |  | 72h post-surgery | 
| Salivary α-amylase levels at 1 month post-surgery |  | 1 month post- surgery | 
| Salivary α-amylase at 6 months post-surgery |  | 6 months post-surgery | 
| Salivary α-amylase at 12 months post-surgery |  | 12 months post-surgery | 
| Inflammatory biomarkers | IL-1β, IL-6, IL-10, TNFα, MCP-1, hs-CRP | 24h before surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee Arthroplasty, Hypnosis, Pain Neuroscience Education, Pain, Catastrophizing, Optimism, Distress, Hope, Self-Efficacy