xml: <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/NCT05981261</url>
    </required_header>
    <id_info>
      <org_study_id>Experimental pain in PD</org_study_id>
      <nct_id>NCT05981261</nct_id>
    </id_info>
    <brief_title>Experimental Pain in Parkinsons</brief_title>
    <acronym>ExPainPD</acronym>
    <official_title>Comparing Pain Intensity and Discomfort in Patients With Parkinson´s Disease and Healthy Controls During Inducement of Mechanical, Thermal, and Chemical Experimental Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Aarhus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Aarhus University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Aarhus</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>
        Study comparing pain intensity and discomfort in patients with Parkinson´s disease and&#xD;
        healthy controls during inducement of mechanical, thermal, and chemical experimental pain&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Project: Inducing experimental muscle pain in healthy volunteers, patients with Parkinson's&#xD;
        disease in levodopa treatment, and patients with Parkinson's disease with deep brain&#xD;
        stimulation treatment&#xD;
  &#xD;
        Research team:&#xD;
  &#xD;
          -  Andrea S. Poulsen (PI), PhD-student, AU&#xD;
  &#xD;
          -  Sophie Rosenkjær, PhD-student, AU&#xD;
  &#xD;
          -  Lene Vase, Professor, AU&#xD;
  &#xD;
          -  Nanna B. Finnerup, Professor, AUH&#xD;
  &#xD;
          -  Mette Møller, Leading doctor, AUH&#xD;
  &#xD;
          -  Erisela Qerama Montvilas, Clinical lector, AUH&#xD;
  &#xD;
          -  Jan Rosner, Post-doc, AUH&#xD;
  &#xD;
        Objective: Comparing induced pain levels in (1) healthy volunteers, (2) patients with&#xD;
        Parkinson's disease in levodopa treatment, and (3) patients with Parkinson's disease with&#xD;
        deep brain stimulation treatment&#xD;
  &#xD;
        Participants: 21 healthy volunteers, 21 patients with Parkinson's disease in levodopa&#xD;
        treatment, and 21 patients with Parkinson's disease with deep brain stimulation treatment&#xD;
        will be recruited from the Department of Neurology at Aarhus University Hospital.&#xD;
        Furthermore, recruitment sheets will be posted at Aarhus University Hospital, at&#xD;
        Parkinsonforeningen's webpage (https://www.parkinson.dk/) and newsletter and in local&#xD;
        newspapers. A power calculation for a Wilcoxcon-Mann-Whitney rank sum test (Three groups)&#xD;
        determine 21 in three test groups is adequate (effect size= 0.8; 1-β=.80; α=.05).&#xD;
  &#xD;
        Design:Between-subject randomized study where each participant will complete a ≈1 ½ hour test&#xD;
        session at the Department of Neurophysiology, Aarhus University Hospital, Denmark. Each test&#xD;
        session will include assessment of ongoing pain, experimental pain (thermal, mechanical, and&#xD;
        chemical), and motor response latencies.&#xD;
  &#xD;
        Procedure: Each test session proceeds as follow: First, participant is greeted in the entry&#xD;
        hall at AUH and escorted to the examination room. Investigator goes through test procedures&#xD;
        and introduce to assessments. Participant complete measures of ongoing pain followed by&#xD;
        assessment of motor response latencies. Then, assessments of thermal heat detection, pain&#xD;
        thresholds and pain-autonomic interactions on volar forearm. Next, sites of inducement of&#xD;
        mechanical and chemical pain (randomized gluteus medius muscle, tibialis anterior muscle, and&#xD;
        infraspinatus muscle) will be identified by use of manual palpation and defined by distinct&#xD;
        anatomical landmarks marked with a pen. For each site: assessment of mechanical pain&#xD;
        threshold followed by evaluation of intensity and discomfort during pain suprathreshold.&#xD;
        Then, inducement of chemical pain by use of hypertonic saline injections. Immediately after&#xD;
        injection, evaluation of pain intensity and discomfort followed by assessment of sensory and&#xD;
        affective verbal descriptions of pain and patient drawings of pain size and distribution.&#xD;
        Finally, measures of pain intensity and discomfort during mechanical suprathreshold pressure&#xD;
        on site of injection. There will be a 15 minutes interval between inducement of experimental&#xD;
        pain in the three sites for the pain to cease. Investigator escorts participant to the entry&#xD;
        hall and thank participant for taking part in the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 7, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>This is a within-subject design where each participant is exposed to experimental pain in infraspinatus muscle, gluteus medius muscle, and tibialis anteior muscle in a randomized order.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Thermal induced heat pain</measure>
      <time_frame>Immediately after assessment of ongoing pain (15 minutes)</time_frame>
      <description>Thermal heat detection and pain thresholds will be measured following the standardized &quot;Quantitative Sensory Testing&quot; protocol</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mechanical induced pain</measure>
      <time_frame>Immediately after assessment of thermal induced heat pain (15 minutes)</time_frame>
      <description>Mechanical pain thresholds and suprathresholds will be measured by use of a handhold pressor algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe placed on test muscle (gluteus medius muscle, tibialis anterior muscle, and infraspinatus muscle in a randomized order)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Chemical induced pain</measure>
      <time_frame>Immediately after assessment of mechanical pain (15 minutes)</time_frame>
      <description>Chemical pain will be induced by an injection of hypertonic saline (HS, 5,8% in 1 ml)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ongoing pain (Clinical pain in daily life)</measure>
      <time_frame>After assessment of motor response latencies measure (15 minutes)</time_frame>
      <description>Intensity and discomfort of ongoing pain in gluteus medius muscle, tibialis anterior muscle, and infraspinatus muscle will be assessed by use of 11- point Numeric Rating Scale (NRS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ongoing pain (Sensory and affective verbal descriptions of pain and patient drawings)</measure>
      <time_frame>After assessment of motor response latencies measures (15 minutes)</time_frame>
      <description>Sensory and affective verbal descriptions of pain and patient drawings of pain size and distribution will be measured by use of the short-form McGill Pain Questionnaire (SF-MPQ).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ongoing pain (Pain in PD)</measure>
      <time_frame>After assessment of motor response latencies measures (15 minutes)</time_frame>
      <description>Pain in PD will be assessed by King´s Parkinson´s disease pain scale (KPPS)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Motor response latencies measure</measure>
      <time_frame>Prior to assessment of ongoing pain (3 minutes)</time_frame>
      <description>To control for bias due to reaction time in measures which include participant stop buttons, motor response latencies will be assessed by use of a response box</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">63</enrollment>
    <condition>Pain</condition>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Experimental pain</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Experimental pain</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>inducement of experimental pain</intervention_name>
      <description>Inducement of experimental pain</description>
      <arm_group_label>Experimental pain</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            -  Group healthy volunteers: healthy subjects with no PD diagnosis&#xD;
  &#xD;
            -  Group PD patients levodopa: Include PD patients treated with levodopa&#xD;
  &#xD;
            -  Group PD patients DBS: Include PD patients with DBS Exclusion criteria&#xD;
  &#xD;
            -  Known other neurological or medical disorders (e.g., stroke, neuropathy, diabetes) or&#xD;
               other disorders with expected influence on experimental pain&#xD;
  &#xD;
            -  Known dementia (a score &lt;24 on the MoCA)&#xD;
  &#xD;
            -  Known untreated depression (a score ≥15 on the Beck Depression Inventory)&#xD;
  &#xD;
            -  Unable to cooperate&#xD;
  &#xD;
            -  Treated with painkillers except paracetamol and NSAID (except if pain and treatment is&#xD;
               ad-equately stable as evaluated by a doctor)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Andrea Søndergaard Poulsen, PhD student</last_name>
      <phone>+4561110138</phone>
      <email>andrea-s-p@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lene Vase, Professor</last_name>
      <email>lenevase@psy.au.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>aarhus university Hospital</name>
        <address>
          <city>Aarhus</city>
          <zip>8000</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andrea Søndergaard Poulsen</last_name>
        <phone>+4561110138</phone>
        <email>andrea-s-p@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 9, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981261
  org study id: Experimental pain in PD
  nct id: NCT05981261
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Study comparing pain intensity and discomfort in patients with Parkinson´s disease and
        healthy controls during inducement of mechanical, thermal, and chemical experimental pain
  Project: Inducing experimental muscle pain in healthy volunteers, patients with Parkinson's
        disease in levodopa treatment, and patients with Parkinson's disease with deep brain
        stimulation treatment
  
        Research team:
  
          -  Andrea S. Poulsen (PI), PhD-student, AU
  
          -  Sophie Rosenkjær, PhD-student, AU
  
          -  Lene Vase, Professor, AU
  
          -  Nanna B. Finnerup, Professor, AUH
  
          -  Mette Møller, Leading doctor, AUH
  
          -  Erisela Qerama Montvilas, Clinical lector, AUH
  
          -  Jan Rosner, Post-doc, AUH
  
        Objective: Comparing induced pain levels in (1) healthy volunteers, (2) patients with
        Parkinson's disease in levodopa treatment, and (3) patients with Parkinson's disease with
        deep brain stimulation treatment
  
        Participants: 21 healthy volunteers, 21 patients with Parkinson's disease in levodopa
        treatment, and 21 patients with Parkinson's disease with deep brain stimulation treatment
        will be recruited from the Department of Neurology at Aarhus University Hospital.
        Furthermore, recruitment sheets will be posted at Aarhus University Hospital, at
        Parkinsonforeningen's webpage (https://www.parkinson.dk/) and newsletter and in local
        newspapers. A power calculation for a Wilcoxcon-Mann-Whitney rank sum test (Three groups)
        determine 21 in three test groups is adequate (effect size= 0.8; 1-β=.80; α=.05).
  
        Design:Between-subject randomized study where each participant will complete a ≈1 ½ hour test
        session at the Department of Neurophysiology, Aarhus University Hospital, Denmark. Each test
        session will include assessment of ongoing pain, experimental pain (thermal, mechanical, and
        chemical), and motor response latencies.
  
        Procedure: Each test session proceeds as follow: First, participant is greeted in the entry
        hall at AUH and escorted to the examination room. Investigator goes through test procedures
        and introduce to assessments. Participant complete measures of ongoing pain followed by
        assessment of motor response latencies. Then, assessments of thermal heat detection, pain
        thresholds and pain-autonomic interactions on volar forearm. Next, sites of inducement of
        mechanical and chemical pain (randomized gluteus medius muscle, tibialis anterior muscle, and
        infraspinatus muscle) will be identified by use of manual palpation and defined by distinct
        anatomical landmarks marked with a pen. For each site: assessment of mechanical pain
        threshold followed by evaluation of intensity and discomfort during pain suprathreshold.
        Then, inducement of chemical pain by use of hypertonic saline injections. Immediately after
        injection, evaluation of pain intensity and discomfort followed by assessment of sensory and
        affective verbal descriptions of pain and patient drawings of pain size and distribution.
        Finally, measures of pain intensity and discomfort during mechanical suprathreshold pressure
        on site of injection. There will be a 15 minutes interval between inducement of experimental
        pain in the three sites for the pain to cease. Investigator escorts participant to the entry
        hall and thank participant for taking part in the study.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This is a within-subject design where each participant is exposed to experimental pain in infraspinatus muscle, gluteus medius muscle, and tibialis anteior muscle in a randomized order.
  primary purpose: Other
  masking: None (Open Label)
  measure: Thermal induced heat pain
  time frame: Immediately after assessment of ongoing pain (15 minutes)
  description: Thermal heat detection and pain thresholds will be measured following the standardized "Quantitative Sensory Testing" protocol
  measure: Mechanical induced pain
  time frame: Immediately after assessment of thermal induced heat pain (15 minutes)
  description: Mechanical pain thresholds and suprathresholds will be measured by use of a handhold pressor algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe placed on test muscle (gluteus medius muscle, tibialis anterior muscle, and infraspinatus muscle in a randomized order)
  measure: Chemical induced pain
  time frame: Immediately after assessment of mechanical pain (15 minutes)
  description: Chemical pain will be induced by an injection of hypertonic saline (HS, 5,8% in 1 ml)
  measure: Ongoing pain (Clinical pain in daily life)
  time frame: After assessment of motor response latencies measure (15 minutes)
  description: Intensity and discomfort of ongoing pain in gluteus medius muscle, tibialis anterior muscle, and infraspinatus muscle will be assessed by use of 11- point Numeric Rating Scale (NRS)
  measure: Ongoing pain (Sensory and affective verbal descriptions of pain and patient drawings)
  time frame: After assessment of motor response latencies measures (15 minutes)
  description: Sensory and affective verbal descriptions of pain and patient drawings of pain size and distribution will be measured by use of the short-form McGill Pain Questionnaire (SF-MPQ).
  measure: Ongoing pain (Pain in PD)
  time frame: After assessment of motor response latencies measures (15 minutes)
  description: Pain in PD will be assessed by King´s Parkinson´s disease pain scale (KPPS)
  measure: Motor response latencies measure
  time frame: Prior to assessment of ongoing pain (3 minutes)
  description: To control for bias due to reaction time in measures which include participant stop buttons, motor response latencies will be assessed by use of a response box
  arm group label: Experimental pain
  arm group type: Other
  description: Experimental pain
  intervention type: Other
  intervention name: inducement of experimental pain
  description: Inducement of experimental pain
  arm group label: Experimental pain
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Andrea Søndergaard Poulsen, PhD student
  phone: +4561110138
  email: andrea-s-p@hotmail.com
  last name: Lene Vase, Professor
  email: lenevase@psy.au.dk
  facility: 
  status: Recruiting
  contact: 
  country: Denmark
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  sharing ipd: No