Effectiveness of a Psychological Intervention in Patients Undergoing Total Knee Arthroplasty

Knee Arthroplasty, Total Clinical Trial

— PsInTKA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02988947
• Other study ID #: SFRH/BPD/103529/2014
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 18, 2020

Study information

• Verified date: April 2021
• Source: University of Minho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty, Total

Intervention

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.

Locations

Country	Name	City	State
Portugal	Life and Health Sciences Research Institute	Braga

Sponsors (2)

Lead Sponsor	Collaborator
University of Minho	Hospital de Braga

Country where clinical trial is conducted

Portugal, 

Outcome

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