<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/NCT03231566</url>
  </required_header>
  <id_info>
    <org_study_id>710848-3</org_study_id>
    <nct_id>NCT03231566</nct_id>
  </id_info>
  <brief_title>Pain Neuroscience Education in Total Knee Arthroplasty</brief_title>
  <official_title>A Randomized Clinical Trial of Preoperative Pain Neuroscience Education for Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nevada, Las Vegas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nevada, Las Vegas</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>
      To determine if education about pain given prior to Knee Arthroplasty will result in better&#xD;
      outcomes following surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine if a preoperative pain neuroscience education (PNE) program would result in&#xD;
      superior outcomes compared to usual preoperative education for total knee arthroplasty (TKA).&#xD;
      Patients will receive traditional hospital preoperative TKA program (usual care group) or&#xD;
      receive the same program plus an additional 30-minute PNE program (experimental group). Pre&#xD;
      and post measurements at 1, 3 and 6 months for pain, function, fear of movement and pain&#xD;
      catastrophization. We will also compare opioid usage, healthcare expenses and patient&#xD;
      satisfaction between groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2015</start_date>
  <completion_date type="Actual">March 20, 2017</completion_date>
  <primary_completion_date type="Actual">March 20, 2017</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Outcome measures were mailed by patients in prepaid envelopes</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>Change from Baseline to 1 month, 3 months and 6 months post-surgery</time_frame>
    <description>Numeric Pain Rating Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Function</measure>
    <time_frame>Change from Baseline to 1 month, 3 months and 6 months post-surgery</time_frame>
    <description>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Catastrophization</measure>
    <time_frame>Change from Baseline to 1 month, 3 months and 6 months post-surgery</time_frame>
    <description>Pain Catastrophization Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fear of movement</measure>
    <time_frame>Change from Baseline to 1 month, 3 months and 6 months post-surgery</time_frame>
    <description>Tampa Scale of Kinesiophobia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid Use</measure>
    <time_frame>Change at 1 month</time_frame>
    <description>Oral Morphine Dose Equivalents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Expenses</measure>
    <time_frame>Change from Baseline to 1 month, 3 months and 6 months post-surgery</time_frame>
    <description>Costs associated with healthcare utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Change at 1 month, 3 months and 6 months post-surgery</time_frame>
    <description>Likert questions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Total Knee Replacement</condition>
  <arm_group>
    <arm_group_label>Usual education control group (CG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The CG received the traditional hospital preoperative program, which was consistent with current preoperative TKA protocols. The CG received education covering anatomy of the knee joint, information about the joint replacement surgery, what to expect when they were admitted for surgery, what to expect immediately after surgery, pain medications, postoperative rehabilitation/physical therapy, etc. The CG received a hospital-based booklet with this information.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group (EG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The EG underwent an additional 30-minute group PNE program, followed by the usual preoperative education program from the hospital. The PNE program used in this TKA study was an adaptation of the PNE program developed for LS. The educational program was designed to be delivered by a physical therapist in a group session to patients prior to their TKA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pain Neuroscience Education</intervention_name>
    <description>See arm/group description</description>
    <arm_group_label>Experimental group (EG)</arm_group_label>
    <arm_group_label>Usual education control group (CG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be scheduled to have a TKA and their standard preoperative TKA education program,&#xD;
             indicate their willingness to participate in the study, ability to read and understand&#xD;
             English, as the study included the use of an educational booklet, and be able and&#xD;
             willing to complete outcome data for 6 months after TKA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Because all potential participants for this study had been screened and cleared for&#xD;
             their orthopedic surgery, the only exclusion criterion was an unwillingness to&#xD;
             participate in the study and having had a previous TKA or scheduled for a bilateral&#xD;
             TKA.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Nevada Las Vegas - Department of Physical Therapy</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nevada, Las Vegas</investigator_affiliation>
    <investigator_full_name>Emilio J Puentedura, PT, DPT, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <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/NCT03231566
org study id: 710848-3
nct id: NCT03231566
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine if education about pain given prior to Knee Arthroplasty will result in better
      outcomes following surgery
To determine if a preoperative pain neuroscience education (PNE) program would result in
      superior outcomes compared to usual preoperative education for total knee arthroplasty (TKA).
      Patients will receive traditional hospital preoperative TKA program (usual care group) or
      receive the same program plus an additional 30-minute PNE program (experimental group). Pre
      and post measurements at 1, 3 and 6 months for pain, function, fear of movement and pain
      catastrophization. We will also compare opioid usage, healthcare expenses and patient
      satisfaction between groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Outcome measures were mailed by patients in prepaid envelopes
measure: Pain
time frame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
description: Numeric Pain Rating Scale
measure: Function
time frame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
description: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
measure: Pain Catastrophization
time frame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
description: Pain Catastrophization Scale
measure: Fear of movement
time frame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
description: Tampa Scale of Kinesiophobia
measure: Opioid Use
time frame: Change at 1 month
description: Oral Morphine Dose Equivalents
measure: Healthcare Expenses
time frame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
description: Costs associated with healthcare utilization
measure: Patient Satisfaction
time frame: Change at 1 month, 3 months and 6 months post-surgery
description: Likert questions
arm group label: Usual education control group (CG)
arm group type: Active Comparator
description: The CG received the traditional hospital preoperative program, which was consistent with current preoperative TKA protocols. The CG received education covering anatomy of the knee joint, information about the joint replacement surgery, what to expect when they were admitted for surgery, what to expect immediately after surgery, pain medications, postoperative rehabilitation/physical therapy, etc. The CG received a hospital-based booklet with this information.
arm group label: Experimental group (EG)
arm group type: Experimental
description: The EG underwent an additional 30-minute group PNE program, followed by the usual preoperative education program from the hospital. The PNE program used in this TKA study was an adaptation of the PNE program developed for LS. The educational program was designed to be delivered by a physical therapist in a group session to patients prior to their TKA.
intervention type: Behavioral
intervention name: Pain Neuroscience Education
description: See arm/group description
arm group label: Experimental group (EG)
arm group label: Usual education control group (CG)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nevada, Las Vegas
investigator full name: Emilio J Puentedura, PT, DPT, PhD
investigator title: Associate Professor
sharing ipd: No