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

This study is not yet open for participant recruitment.
Verified October 2017 by Patrícia Ribeiro Pinto, University of Minho
Sponsor:
ClinicalTrials.gov Identifier:
NCT02988947
First Posted: December 12, 2016
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Hospital de Braga
Information provided by (Responsible Party):
Patrícia Ribeiro Pinto, University of Minho
  Purpose
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

Condition Intervention
Knee Arthroplasty, Total Other: PNE+HyP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Patrícia Ribeiro Pinto, University of Minho:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 [ 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 [ Time Frame: 24h before surgery ]
    IL-1β, IL-6, IL-10, TNFα, MCP-1, hs-CRP


Estimated Enrollment: 128
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988947


Contacts
Contact: Patricia R Pinto, PhD 00351253604926 patipinto@med.uminho.pt

Locations
Portugal
Life and Health Sciences Research Institute Not yet recruiting
Braga, Portugal, 4710-057
Contact: Patrícia R Pinto, PhD    00351253604926    patipinto@med.uminho.pt   
Sponsors and Collaborators
University of Minho
Hospital de Braga
  More Information

Responsible Party: Patrícia Ribeiro Pinto, Post-doctoral fellow, University of Minho
ClinicalTrials.gov Identifier: NCT02988947     History of Changes
Other Study ID Numbers: SFRH/BPD/103529/2014
First Submitted: August 9, 2016
First Posted: December 12, 2016
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patrícia Ribeiro Pinto, University of Minho:
Knee Arthroplasty
Hypnosis
Pain Neuroscience Education
Pain
Catastrophizing
Optimism
Distress
Hope
Self-Efficacy