Effectiveness of a Psychological Intervention in Patients Undergoing Total Knee Arthroplasty

University of Minho2 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Knee Arthroplasty, Total

Interventions

PNE+HyPOTHER

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Life and Health Sciences Research Institute

Braga, Portugal

Outcomes

Primary Outcomes

Pain intensity post-intervention as assessed by Numerical Rating Scale (NRS) and WOMAC

Time frame: 24h before surgery

Pain intensity 72h post-surgery as assessed by NRS

Time frame: 72h post-surgery

Pain intensity 1 month post-surgery as assessed by NRS and WOMAC

Time frame: 1 month post-surgery

Pain intensity 6 months post-surgery as assessed by NRS and WOMAC

Time frame: 6 months post-surgery

Pain intensity 12 months post-surgery as assessed by NRS and WOMAC

Time frame: 12 months post-surgery

Secondary Outcomes

Physical functioning post-intervention as assessed by WOMAC

Time frame: 24h before surgery

Physical functioning 1 month post-surgery as assessed by WOMAC

Time frame: 1 month post-surgery

Physical functioning 6 months post-surgery as assessed by WOMAC

Time frame: 6 months post-surgery

Physical functioning 12 months post-surgery as assessed by WOMAC

Time frame: 12 months post-surgery

Pain knowledge post-intervention as assessed by the Neurophisiology of Pain Questionnaire (NPQ)

Time frame: 24h before surgery

Pain knowledge 1 month post-surgery as assessed by the NPQ

Data from ClinicalTrials.gov

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Time frame: 1 month post-surgery

Pain knowledge 6 months post-surgery as assessed by NPQ

Time frame: 6 months post-surgery

Pain knowledge 12 months post-surgery as assessed by NPQ

Time frame: 12 months post-surgery

Emotional distress post-intervention as assessed by the Hospital Anxiety and Depression Scale (HADS)

Time frame: 24h before surgery

Emotional distress 1 month post-surgery as assessed by HADS

Time frame: 1 month post-surgery

Emotional distress 6 months post-surgery as assessed by HADS

Time frame: 6 months post-surgery

Emotional distress 12 months post-surgery as assessed by HADS

Time frame: 12 months post-surgery

Optimism post-intervention as assessed by the Life Orientation Test (LOT-R)

Time frame: 24h before surgery

Optimism 1 month post-surgery as assessed by LOT

Time frame: 1 month post-surgery

Optimism 6 months post-surgery as assessed by LOT-R

Time frame: 6 months post-surgery

Optimism 12 months post-surgery as assessed LOT-R

Time frame: 12 months post-surgery

Pain coping strategies post-intervention as assessed by the Coping Strategies Questionnaire (CSQ)

Time frame: 24h before surgery

Pain coping strategies 1 month post-surgery as assessed by CSQ

Time frame: 1 month post-surgery

Pain coping strategies at 6 months post-surgery as assessed by CSQ

Time frame: 6 months post-surgery

Pain coping strategies at 12 months post-surgery as assessed by CSQ

Time frame: 12 months post-surgery

Hope post-intervention as assessed by the Portuguese Hope Scale (Escala Sobre a Esperança - ESE)

Time frame: 24h before surgery

Hope at 1 month post-surgery as assessed by ESE

Time frame: 1 month post-surgery

Hope at 6 months post-surgery as assessed by ESE

Time frame: 6 months post-surgery

Hope at 12 months post-surgery as assessed by ESE

Time frame: 12 months post-surgery

Self-Efficacy post-intervention as assessed by the Self-Efficacy Scale developed for this study (KSESS)

Time frame: 24h before surgery

Self-Efficacy at 1 month post-surgery as assessed by KSESS

Time frame: 1 month post-surgery

Self-Efficacy at 6 months post-surgery as assessed by KSESS

Time frame: 6 months post-surgery

Self-Efficacy at 12 months post-surgery as assessed by KSESS

Time frame: 12 months post-surgery

Salivary cortisol levels post-intervention

Time frame: 24h before surgery

Salivary cortisol levels 72h post-surgery

Time frame: 72h post-surgery

Salivary cortisol levels at 1 month post-surgery

Time frame: 1 month post-surgery

Salivary cortisol levels at 6 months post-surgery

Time frame: 6 months post-surgery

Salivary cortisol levels at 12 months post-surgery

Time frame: 12 months post-surgery

Salivary α-amylase levels post-intervention

Time frame: 24h before surgery

Salivary α-amylase levels 72h post-surgery

Time frame: 72h post-surgery

Salivary α-amylase levels at 1 month post-surgery

Time frame: 1 month post- surgery

Salivary α-amylase at 6 months post-surgery

Time frame: 6 months post-surgery

Salivary α-amylase at 12 months post-surgery

Time frame: 12 months post-surgery

Inflammatory biomarkers

IL-1β, IL-6, IL-10, TNFα, MCP-1, hs-CRP

Time frame: 24h before surgery