<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/NCT02261012</url>
  </required_header>
  <id_info>
    <org_study_id>CRPS2014</org_study_id>
    <nct_id>NCT02261012</nct_id>
  </id_info>
  <brief_title>Examination of the Pathophysiologic Mechanisms of CRPS by Using QST, CPM, RIC, and Heart Rate Variability QST</brief_title>
  <official_title>Examination of the Pathological Mechanism of the Complex Regional Pain Syndrome of the Upper Limb in Comparison to Patients With Painful Carpal Tunnel Syndrome and Healthy Subjects - an Explorative Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruhr University of Bochum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruhr University of Bochum</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims for a better understanding of the pathophysiological mechanisms of the&#xD;
      complex regional pain syndrome (CRPS). This will be done by testing the quantitative sensory&#xD;
      testing, the remote ischemic conditioning, the conditioned pain modulation (CPM) and the&#xD;
      analysis of the heart-rate variability in patients with CRPS and a control-group. We&#xD;
      hypothesize decreased conditioned pain modulation, less effects of remote ischemic&#xD;
      conditioning and an affection of the heart-rate variability in patients with CPRS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CRPS is an illness which (seriously) affects patients in their daily life activity. The fact&#xD;
      that the pathophysiological mechanisms are not well understood yet makes it hard to treat&#xD;
      these patients in the right manner.&#xD;
&#xD;
      Possible patho-mechanisms might be microvascular changes and dysfunctions of the inhibitory&#xD;
      descending pain system. Furthermore, recent studies showed that CRPS patients have&#xD;
      macrovascular changes and a lower blood level of NO on the affected side. This indicates a NO&#xD;
      mediated perfusion dysfunction.&#xD;
&#xD;
      Aim of this study is to examine the pathophysiological mechanism of CRPS in relation to&#xD;
      healthy subjects and patients with a different type of pain syndrome (carpal tunnel syndrome)&#xD;
      on the upper limb.&#xD;
&#xD;
      The investigators try to get a better understanding of the changes in the pain inhibitory&#xD;
      system and micro- and macrocirculating blood-systems, as well as of the autonomic system of&#xD;
      CRPS-patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CPM effect</measure>
    <time_frame>60 seconds</time_frame>
    <description>Conditioned Pain Modulation measured by the Heat-Cold-Pain Method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Remote Ischemic Conditioning</measure>
    <time_frame>45 minutes</time_frame>
    <description>the perfusion increasing effect after RIC in all groups</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>Complex Regional Pain Syndrome</condition>
  <condition>Carpal Tunnel Syndrome</condition>
  <condition>Neuralgia</condition>
  <arm_group>
    <arm_group_label>30 healthy probands</arm_group_label>
    <description>group without the condition of interest</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 CRPS patients</arm_group_label>
    <description>group with condition of interest</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 CTS patients</arm_group_label>
    <description>group with a different type of pain on the upper limbs</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy subjects, CRPS-patients, CTS-patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        CRPS-patients&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral pain on the upper limbs, based on a scintigraphic ensured CRPS (average&#xD;
             pain in the last 4 weeks ≥ 3 in pain Detect)&#xD;
&#xD;
          -  Pain history &lt; 1 year&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Bilateral pain on the upper limbs&#xD;
&#xD;
          -  Inadequate knowledge of the german language in speaking and writing&#xD;
&#xD;
          -  Acute psychiatric sickness&#xD;
&#xD;
          -  Polyneuropathy&#xD;
&#xD;
          -  Any added neuropathic sickness on the not affected upper limb sight&#xD;
&#xD;
          -  Intolerable pain during the testing&#xD;
&#xD;
          -  Injuries within the tested areal&#xD;
&#xD;
          -  Acute injuries on the hand&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Missing informed consent&#xD;
&#xD;
        CTS-patients&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral pain on the upper limbs, based on a scintigraphic ensured CRPS (average&#xD;
             pain in the last 4 weeks ≥ 3 in pain Detect)&#xD;
&#xD;
          -  Pain history &lt; 1 year&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Bilateral pain on the upper limbs&#xD;
&#xD;
          -  Inadequate knowledge of the german language in speaking and writing&#xD;
&#xD;
          -  Acute psychiatric sickness&#xD;
&#xD;
          -  Polyneuropathy&#xD;
&#xD;
          -  Any added neuropathic sickness on the not affected upper limb sight&#xD;
&#xD;
          -  Intolerable pain during the testing&#xD;
&#xD;
          -  Injuries within the tested areal&#xD;
&#xD;
          -  Acute injuries on the hand&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Missing informed consent&#xD;
&#xD;
        Healthy subjects&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Inadequate knowledge of the german language in speaking and writing&#xD;
&#xD;
          -  Current pain&#xD;
&#xD;
          -  Pain within in the last 14 days&#xD;
&#xD;
          -  Any serious internistic medicin&#xD;
&#xD;
          -  Any chronic skin disease&#xD;
&#xD;
          -  Any central neural sickness&#xD;
&#xD;
          -  Polyneuropathy&#xD;
&#xD;
          -  Peripheral nerve lesion within the testing areal&#xD;
&#xD;
          -  Any radiculopathy with permanent pain (in the last 3 months)&#xD;
&#xD;
          -  Any psychiatric sickness&#xD;
&#xD;
          -  Migraine ( at least one attack in the last 24 h)&#xD;
&#xD;
          -  Repeating headache (in the last 3 month on &gt;5 days/month)&#xD;
&#xD;
          -  Taking any analgesics in the last 14 days&#xD;
&#xD;
          -  Taking triptans in the last 24 months&#xD;
&#xD;
          -  Taking any psychotropic's in the last 3 months&#xD;
&#xD;
          -  Any repeated taking of medication, including amber or different psychostimulants&#xD;
             (excluding contraceptives)&#xD;
&#xD;
          -  Taking of any prescription and non-prescription drugs (except contraceptives) in the&#xD;
             last 7 days or 5 half-life periods(which is always longer) before including into the&#xD;
             study&#xD;
&#xD;
          -  Achilles reflex absent or within in the side-difference pathologic hypoactive or&#xD;
             hyperactive&#xD;
&#xD;
          -  pallaesthesia &lt;5/8 (&lt;4/8 at &gt;60 years) on the internal malleolus on both sides&#xD;
&#xD;
          -  abuse of alcohol or medications/drugs (corresponding to the DSM IV criteria)&#xD;
&#xD;
          -  joining a medical study &lt;30 days before inclusion into the current study&#xD;
&#xD;
          -  jet lag, irregular work schedule, sleep deprivation within the last 3 days&#xD;
&#xD;
          -  change of intestity during physical activity, e.g. beginning an activity in the last&#xD;
             weeks before inclusion into the current study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tina Mainka, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Bergmannsheil, Department of Pain Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH</name>
      <address>
        <city>Bochum</city>
        <state>Nordrhein-Westfalen</state>
        <zip>44789</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>February 7, 2016</last_update_submitted>
  <last_update_submitted_qc>February 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruhr University of Bochum</investigator_affiliation>
    <investigator_full_name>Christoph Maier, Prof. Dr.</investigator_full_name>
    <investigator_title>Head of the Dep. of Pain Management</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Complex Regional Pain Syndromes</mesh_term>
    <mesh_term>Reflex Sympathetic Dystrophy</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT02261012
org study id: CRPS2014
nct id: NCT02261012
lead sponsor: 
has dmc: No
This study aims for a better understanding of the pathophysiological mechanisms of the
      complex regional pain syndrome (CRPS). This will be done by testing the quantitative sensory
      testing, the remote ischemic conditioning, the conditioned pain modulation (CPM) and the
      analysis of the heart-rate variability in patients with CRPS and a control-group. We
      hypothesize decreased conditioned pain modulation, less effects of remote ischemic
      conditioning and an affection of the heart-rate variability in patients with CPRS.
CRPS is an illness which (seriously) affects patients in their daily life activity. The fact
      that the pathophysiological mechanisms are not well understood yet makes it hard to treat
      these patients in the right manner.

      Possible patho-mechanisms might be microvascular changes and dysfunctions of the inhibitory
      descending pain system. Furthermore, recent studies showed that CRPS patients have
      macrovascular changes and a lower blood level of NO on the affected side. This indicates a NO
      mediated perfusion dysfunction.

      Aim of this study is to examine the pathophysiological mechanism of CRPS in relation to
      healthy subjects and patients with a different type of pain syndrome (carpal tunnel syndrome)
      on the upper limb.

      The investigators try to get a better understanding of the changes in the pain inhibitory
      system and micro- and macrocirculating blood-systems, as well as of the autonomic system of
      CRPS-patients.
observational model: Case-Control
time perspective: Prospective
measure: CPM effect
time frame: 60 seconds
description: Conditioned Pain Modulation measured by the Heat-Cold-Pain Method
measure: Remote Ischemic Conditioning
time frame: 45 minutes
description: the perfusion increasing effect after RIC in all groups
arm group label: 30 healthy probands
description: group without the condition of interest
arm group label: 30 CRPS patients
description: group with condition of interest
arm group label: 30 CTS patients
description: group with a different type of pain on the upper limbs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tina Mainka, Dr. med.
role: Principal Investigator
affiliation: University Hospital Bergmannsheil, Department of Pain Medicine
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ruhr University of Bochum
investigator full name: Christoph Maier, Prof. Dr.
investigator title: Head of the Dep. of Pain Management
mesh term: Carpal Tunnel Syndrome
mesh term: Neuralgia
mesh term: Complex Regional Pain Syndromes
mesh term: Reflex Sympathetic Dystrophy
mesh term: Syndrome