<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02988947</url>
  </required_header>
  <id_info>
    <org_study_id>SFRH/BPD/103529/2014</org_study_id>
    <nct_id>NCT02988947</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Psychological Intervention in Patients Undergoing Total Knee Arthroplasty</brief_title>
  <acronym>PsInTKA</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital de Braga</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minho</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness of a combined Pain Neuroscience&#xD;
      Education (PNE) and Hypnosis (HyP) psychological intervention aiming at the control and&#xD;
      prevention of pain and promotion of post-surgical recovery in patients undergoing Total Knee&#xD;
      Arthroplasty&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective Randomized Controlled Trial (RCT), comparing an experimental group&#xD;
      (EG), submitted to a PNE/HyP based psychological intervention, and a control group (CG),&#xD;
      submitted to usual treatment and care.&#xD;
&#xD;
      After recruitment and evaluation of inclusion/exclusion criteria, patients entering the study&#xD;
      will sign the Informed Consent. Baseline evaluation is performed at 1 month pre-surgery and,&#xD;
      afterwards, patients are randomly assigned to EG (PNE+Hyp plus usual care) or CG (usual care&#xD;
      only). The EG will be submitted to 3 pre-surgical and 1 (or 2) post-surgical reinforcement&#xD;
      sessions. At 1 month post-surgery, the intervention group will be subdivided and participants&#xD;
      will be randomly assigned to receive a reinforcement session or no intervention at this&#xD;
      point. The psychological intervention sessions are based on the educative principles of Pain&#xD;
      Neuroscience Education and on Hypnosis strategies for the promotion of pain control, positive&#xD;
      coping strategies and psychological variables.&#xD;
&#xD;
      Patients will be evaluated on 6 moments: T0 - baseline, 1 month pre surgery; T1 - post&#xD;
      intervention/24h before surgery; T2 - 72h post-surgery; T3 - 1 month post surgery; T4 - 6&#xD;
      months post surgery; T5 - 12 months post intervention. Patients will fill in self report&#xD;
      measures and perform physiological evaluation to analyse relevant bio-markers (salivary&#xD;
      cortisol and α-amylase) that are related to stress levels and SNS functioning and translate&#xD;
      the impact of psychological interventions on physiological parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unavailability of the clinical team&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 18, 2020</completion_date>
  <primary_completion_date type="Actual">December 18, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity post-intervention as assessed by Numerical Rating Scale (NRS) and WOMAC</measure>
    <time_frame>24h before surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain intensity 72h post-surgery as assessed by NRS</measure>
    <time_frame>72h post-surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain intensity 1 month post-surgery as assessed by NRS and WOMAC</measure>
    <time_frame>1 month post-surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain intensity 6 months post-surgery as assessed by NRS and WOMAC</measure>
    <time_frame>6 months post-surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain intensity 12 months post-surgery as assessed by NRS and WOMAC</measure>
    <time_frame>12 months post-surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical functioning post-intervention as assessed by WOMAC</measure>
    <time_frame>24h before surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical functioning 1 month post-surgery as assessed by WOMAC</measure>
    <time_frame>1 month post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical functioning 6 months post-surgery as assessed by WOMAC</measure>
    <time_frame>6 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical functioning 12 months post-surgery as assessed by WOMAC</measure>
    <time_frame>12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain knowledge post-intervention as assessed by the Neurophisiology of Pain Questionnaire (NPQ)</measure>
    <time_frame>24h before surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain knowledge 1 month post-surgery as assessed by the NPQ</measure>
    <time_frame>1 month post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain knowledge 6 months post-surgery as assessed by NPQ</measure>
    <time_frame>6 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain knowledge 12 months post-surgery as assessed by NPQ</measure>
    <time_frame>12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional distress post-intervention as assessed by the Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>24h before surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional distress 1 month post-surgery as assessed by HADS</measure>
    <time_frame>1 month post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional distress 6 months post-surgery as assessed by HADS</measure>
    <time_frame>6 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional distress 12 months post-surgery as assessed by HADS</measure>
    <time_frame>12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimism post-intervention as assessed by the Life Orientation Test (LOT-R)</measure>
    <time_frame>24h before surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimism 1 month post-surgery as assessed by LOT</measure>
    <time_frame>1 month post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimism 6 months post-surgery as assessed by LOT-R</measure>
    <time_frame>6 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimism 12 months post-surgery as assessed LOT-R</measure>
    <time_frame>12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain coping strategies post-intervention as assessed by the Coping Strategies Questionnaire (CSQ)</measure>
    <time_frame>24h before surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain coping strategies 1 month post-surgery as assessed by CSQ</measure>
    <time_frame>1 month post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain coping strategies at 6 months post-surgery as assessed by CSQ</measure>
    <time_frame>6 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain coping strategies at 12 months post-surgery as assessed by CSQ</measure>
    <time_frame>12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hope post-intervention as assessed by the Portuguese Hope Scale (Escala Sobre a Esperança - ESE)</measure>
    <time_frame>24h before surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hope at 1 month post-surgery as assessed by ESE</measure>
    <time_frame>1 month post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hope at 6 months post-surgery as assessed by ESE</measure>
    <time_frame>6 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hope at 12 months post-surgery as assessed by ESE</measure>
    <time_frame>12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy post-intervention as assessed by the Self-Efficacy Scale developed for this study (KSESS)</measure>
    <time_frame>24h before surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy at 1 month post-surgery as assessed by KSESS</measure>
    <time_frame>1 month post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy at 6 months post-surgery as assessed by KSESS</measure>
    <time_frame>6 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy at 12 months post-surgery as assessed by KSESS</measure>
    <time_frame>12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary cortisol levels post-intervention</measure>
    <time_frame>24h before surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary cortisol levels 72h post-surgery</measure>
    <time_frame>72h post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary cortisol levels at 1 month post-surgery</measure>
    <time_frame>1 month post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary cortisol levels at 6 months post-surgery</measure>
    <time_frame>6 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary cortisol levels at 12 months post-surgery</measure>
    <time_frame>12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary α-amylase levels post-intervention</measure>
    <time_frame>24h before surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary α-amylase levels 72h post-surgery</measure>
    <time_frame>72h post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary α-amylase levels at 1 month post-surgery</measure>
    <time_frame>1 month post- surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary α-amylase at 6 months post-surgery</measure>
    <time_frame>6 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary α-amylase at 12 months post-surgery</measure>
    <time_frame>12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory biomarkers</measure>
    <time_frame>24h before surgery</time_frame>
    <description>IL-1β, IL-6, IL-10, TNFα, MCP-1, hs-CRP</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Knee Arthroplasty, Total</condition>
  <arm_group>
    <arm_group_label>Intervention Group (PNE+HyP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention / Standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PNE+HyP</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention Group (PNE+HyP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Planned unilateral total knee arthroplasty due to gonarthrosis&#xD;
&#xD;
          -  Giving consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to write and read&#xD;
&#xD;
          -  Cognitive deficit (assessed by MMSE)&#xD;
&#xD;
          -  Revision TKA&#xD;
&#xD;
          -  Bilateral TKA&#xD;
&#xD;
          -  TKA for reasons other than gonarthrosis (fracture, malignancy or infection)&#xD;
&#xD;
          -  Psychiatric or neurological deficit (e.g. Schizophrenia or Alzheimers')&#xD;
&#xD;
          -  Diagnosis of rheumatoid arthritis, Psoriatic arthritis, Systemic lupus erythematosus,&#xD;
             Anquilosant spondylitis or other severe disease&#xD;
&#xD;
          -  Contralateral hip or knee arthroplasty in the previous 6 months&#xD;
&#xD;
          -  Planned contralateral hip or knee arthroplasty in the next 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Life and Health Sciences Research Institute</name>
      <address>
        <city>Braga</city>
        <zip>4710-057</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Minho</investigator_affiliation>
    <investigator_full_name>Patrícia Ribeiro Pinto</investigator_full_name>
    <investigator_title>Post-doctoral fellow</investigator_title>
  </responsible_party>
  <keyword>Knee Arthroplasty</keyword>
  <keyword>Hypnosis</keyword>
  <keyword>Pain Neuroscience Education</keyword>
  <keyword>Pain</keyword>
  <keyword>Catastrophizing</keyword>
  <keyword>Optimism</keyword>
  <keyword>Distress</keyword>
  <keyword>Hope</keyword>
  <keyword>Self-Efficacy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02988947
org study id: SFRH/BPD/103529/2014
nct id: NCT02988947
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Pain intensity post-intervention as assessed by Numerical Rating Scale (NRS) and WOMAC
time frame: 24h before surgery
measure: Pain intensity 72h post-surgery as assessed by NRS
time frame: 72h post-surgery
measure: Pain intensity 1 month post-surgery as assessed by NRS and WOMAC
time frame: 1 month post-surgery
measure: Pain intensity 6 months post-surgery as assessed by NRS and WOMAC
time frame: 6 months post-surgery
measure: Pain intensity 12 months post-surgery as assessed by NRS and WOMAC
time frame: 12 months post-surgery
measure: Physical functioning post-intervention as assessed by WOMAC
time frame: 24h before surgery
measure: Physical functioning 1 month post-surgery as assessed by WOMAC
time frame: 1 month post-surgery
measure: Physical functioning 6 months post-surgery as assessed by WOMAC
time frame: 6 months post-surgery
measure: Physical functioning 12 months post-surgery as assessed by WOMAC
time frame: 12 months post-surgery
measure: Pain knowledge post-intervention as assessed by the Neurophisiology of Pain Questionnaire (NPQ)
time frame: 24h before surgery
measure: Pain knowledge 1 month post-surgery as assessed by the NPQ
time frame: 1 month post-surgery
measure: Pain knowledge 6 months post-surgery as assessed by NPQ
time frame: 6 months post-surgery
measure: Pain knowledge 12 months post-surgery as assessed by NPQ
time frame: 12 months post-surgery
measure: Emotional distress post-intervention as assessed by the Hospital Anxiety and Depression Scale (HADS)
time frame: 24h before surgery
measure: Emotional distress 1 month post-surgery as assessed by HADS
time frame: 1 month post-surgery
measure: Emotional distress 6 months post-surgery as assessed by HADS
time frame: 6 months post-surgery
measure: Emotional distress 12 months post-surgery as assessed by HADS
time frame: 12 months post-surgery
measure: Optimism post-intervention as assessed by the Life Orientation Test (LOT-R)
time frame: 24h before surgery
measure: Optimism 1 month post-surgery as assessed by LOT
time frame: 1 month post-surgery
measure: Optimism 6 months post-surgery as assessed by LOT-R
time frame: 6 months post-surgery
measure: Optimism 12 months post-surgery as assessed LOT-R
time frame: 12 months post-surgery
measure: Pain coping strategies post-intervention as assessed by the Coping Strategies Questionnaire (CSQ)
time frame: 24h before surgery
measure: Pain coping strategies 1 month post-surgery as assessed by CSQ
time frame: 1 month post-surgery
measure: Pain coping strategies at 6 months post-surgery as assessed by CSQ
time frame: 6 months post-surgery
measure: Pain coping strategies at 12 months post-surgery as assessed by CSQ
time frame: 12 months post-surgery
measure: Hope post-intervention as assessed by the Portuguese Hope Scale (Escala Sobre a Esperança - ESE)
time frame: 24h before surgery
measure: Hope at 1 month post-surgery as assessed by ESE
time frame: 1 month post-surgery
measure: Hope at 6 months post-surgery as assessed by ESE
time frame: 6 months post-surgery
measure: Hope at 12 months post-surgery as assessed by ESE
time frame: 12 months post-surgery
measure: Self-Efficacy post-intervention as assessed by the Self-Efficacy Scale developed for this study (KSESS)
time frame: 24h before surgery
measure: Self-Efficacy at 1 month post-surgery as assessed by KSESS
time frame: 1 month post-surgery
measure: Self-Efficacy at 6 months post-surgery as assessed by KSESS
time frame: 6 months post-surgery
measure: Self-Efficacy at 12 months post-surgery as assessed by KSESS
time frame: 12 months post-surgery
measure: Salivary cortisol levels post-intervention
time frame: 24h before surgery
measure: Salivary cortisol levels 72h post-surgery
time frame: 72h post-surgery
measure: Salivary cortisol levels at 1 month post-surgery
time frame: 1 month post-surgery
measure: Salivary cortisol levels at 6 months post-surgery
time frame: 6 months post-surgery
measure: Salivary cortisol levels at 12 months post-surgery
time frame: 12 months post-surgery
measure: Salivary α-amylase levels post-intervention
time frame: 24h before surgery
measure: Salivary α-amylase levels 72h post-surgery
time frame: 72h post-surgery
measure: Salivary α-amylase levels at 1 month post-surgery
time frame: 1 month post- surgery
measure: Salivary α-amylase at 6 months post-surgery
time frame: 6 months post-surgery
measure: Salivary α-amylase at 12 months post-surgery
time frame: 12 months post-surgery
measure: Inflammatory biomarkers
time frame: 24h before surgery
description: IL-1β, IL-6, IL-10, TNFα, MCP-1, hs-CRP
arm group label: Intervention Group (PNE+HyP)
arm group type: Experimental
description: 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.
arm group label: Control Group
arm group type: No Intervention
description: No intervention / Standard care
intervention type: Other
intervention name: PNE+HyP
description: 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.
arm group label: Intervention Group (PNE+HyP)
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: University of Minho
investigator full name: Patrícia Ribeiro Pinto
investigator title: Post-doctoral fellow
sharing ipd: No