Effectiveness of a Psychological Intervention in Patients Undergoing Total Knee Arthroplasty (PsInTKA)

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

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

Study Overview

• Status: Terminated
• Conditions: Knee Arthroplasty, Total
• Intervention / Treatment: Other: PNE+HyP

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Braga, Portugal, 4710-057
    • Life and Health Sciences Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (PNE+HyP); 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; 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.
No Intervention: Control Group; No intervention / Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Minho
• Collaborators: Hospital de Braga

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): December 18, 2020

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 12, 2016

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Hypnosis; Knee Arthroplasty; Catastrophizing; Optimism; Pain Neuroscience Education; Distress; Self-Efficacy; Hope
• Other Study ID Numbers: SFRH/BPD/103529/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No