<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/NCT03022864</url>
  </required_header>
  <id_info>
    <org_study_id>MRI20161121</org_study_id>
    <nct_id>NCT03022864</nct_id>
  </id_info>
  <brief_title>Accurate Diagnosis System for Postoperative Chronic Pain Based on fMRI</brief_title>
  <official_title>Establishment of Accurate Diagnosis and Treatment System for Postoperative Chronic Pain Based on Functional Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative pain is an ideal model for study on acute pain changing into chronic pain. The&#xD;
      functional imaging of magnetic resonance can reflect the extent and character of pain exactly&#xD;
      and the structural imaging of it can be a sign of the change. By analyzing fMRI results of&#xD;
      participants with acute pain and following them up for three months, the investigators expect&#xD;
      to find objective indicators for acute pain changing into chronic pain and give preventive&#xD;
      analgesia for people with high risk of chronic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The day before surgery, evaluate and choose patients according to inclusion and exclusion&#xD;
      criteria. Use the same anaesthesia and management and record information needed by the case&#xD;
      report format. Patients are examined by fMRI on their brains during the first week after&#xD;
      surgery. Follow up the patients after surgery for three months to find out whether they have&#xD;
      chronic pain. The NRS, DN4, ID pain and QLQ-C30 are used for each patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>different fMRI results of specific brain regions between people with and without chronic pain</measure>
    <time_frame>in the first week after surgery</time_frame>
    <description>amplitude of low frequency fluctuation(ALFF) and regional homogeneity(ReHo) of related brain regions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the incidence of chronic pain after mastectomy</measure>
    <time_frame>six months after surgery</time_frame>
    <description>calculate the percentage of participants who rate pain more than three points on numerical rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the quality of life in patients after mastectomy</measure>
    <time_frame>six months after surgery</time_frame>
    <description>the results of brief pain inventory in the first week after surgery and the EORTC QLQ-C30 results in the first, second and third month after surgery</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Mammary Cancer</condition>
  <arm_group>
    <arm_group_label>Chronic pain</arm_group_label>
    <description>Follow up the patients for three months after surgery using the designed table. If the patient evaluate the pain more than 3 points according the Numerical Rating Scale, then it can be considered that the patient has chronic pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No chronic pain</arm_group_label>
    <description>Follow up the patients for three months after surgery using the designed table. If the patient evaluate the pain no more than 3 points according the Numerical Rating Scale, then it can be considered that the patient doesn't have chronic pain.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        people who undergo selective operation of mastectomy with or without axillary lymph node&#xD;
        dissection in ambulatory operation room of Shanghai RenJi Hospital （East part ) during year&#xD;
        2016 to 2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  junior high school degree or above&#xD;
&#xD;
          -  can be communicated in mandarin normally&#xD;
&#xD;
          -  selective operation of mastectomy with or without axillary lymph node dissection&#xD;
&#xD;
          -  similar operation method and incision size&#xD;
&#xD;
          -  BMI between 18 and 30&#xD;
&#xD;
          -  ASA grade I-II；informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with brain disease or with brain disease history&#xD;
&#xD;
          -  Opioid allergy&#xD;
&#xD;
          -  with claustrophobia&#xD;
&#xD;
          -  with history of chronic pain&#xD;
&#xD;
          -  with psychological or emotional problems&#xD;
&#xD;
          -  Serious hearing or visual impairment&#xD;
&#xD;
          -  those who refuse to participant in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weifeng Yu, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>RenJi Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Apkarian AV, Bushnell MC, Treede RD, Zubieta JK. Human brain mechanisms of pain perception and regulation in health and disease. Eur J Pain. 2005 Aug;9(4):463-84. doi: 10.1016/j.ejpain.2004.11.001. Epub 2005 Jan 21.</citation>
    <PMID>15979027</PMID>
  </reference>
  <reference>
    <citation>Bailly F, Maigne JY, Genevay S, Marty M, Gandjbakhch F, Rozenberg S, Foltz V. Inflammatory pain pattern and pain with lumbar extension associated with Modic 1 changes on MRI: a prospective case-control study of 120 patients. Eur Spine J. 2014 Mar;23(3):493-7. doi: 10.1007/s00586-013-3036-6. Epub 2013 Sep 25.</citation>
    <PMID>24221918</PMID>
  </reference>
  <reference>
    <citation>Baliki MN, Geha PY, Fields HL, Apkarian AV. Predicting value of pain and analgesia: nucleus accumbens response to noxious stimuli changes in the presence of chronic pain. Neuron. 2010 Apr 15;66(1):149-60. doi: 10.1016/j.neuron.2010.03.002.</citation>
    <PMID>20399736</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</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>Breast Neoplasms</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <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/NCT03022864
org study id: MRI20161121
nct id: NCT03022864
lead sponsor: 
has dmc: No
Postoperative pain is an ideal model for study on acute pain changing into chronic pain. The
      functional imaging of magnetic resonance can reflect the extent and character of pain exactly
      and the structural imaging of it can be a sign of the change. By analyzing fMRI results of
      participants with acute pain and following them up for three months, the investigators expect
      to find objective indicators for acute pain changing into chronic pain and give preventive
      analgesia for people with high risk of chronic pain.
The day before surgery, evaluate and choose patients according to inclusion and exclusion
      criteria. Use the same anaesthesia and management and record information needed by the case
      report format. Patients are examined by fMRI on their brains during the first week after
      surgery. Follow up the patients after surgery for three months to find out whether they have
      chronic pain. The NRS, DN4, ID pain and QLQ-C30 are used for each patient.
observational model: Case-Control
time perspective: Prospective
measure: different fMRI results of specific brain regions between people with and without chronic pain
time frame: in the first week after surgery
description: amplitude of low frequency fluctuation(ALFF) and regional homogeneity(ReHo) of related brain regions
measure: the incidence of chronic pain after mastectomy
time frame: six months after surgery
description: calculate the percentage of participants who rate pain more than three points on numerical rating scale
measure: the quality of life in patients after mastectomy
time frame: six months after surgery
description: the results of brief pain inventory in the first week after surgery and the EORTC QLQ-C30 results in the first, second and third month after surgery
arm group label: Chronic pain
description: Follow up the patients for three months after surgery using the designed table. If the patient evaluate the pain more than 3 points according the Numerical Rating Scale, then it can be considered that the patient has chronic pain.
arm group label: No chronic pain
description: Follow up the patients for three months after surgery using the designed table. If the patient evaluate the pain no more than 3 points according the Numerical Rating Scale, then it can be considered that the patient doesn't have chronic pain.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Weifeng Yu, Doctor
role: Study Chair
affiliation: RenJi Hospital
citation: Apkarian AV, Bushnell MC, Treede RD, Zubieta JK. Human brain mechanisms of pain perception and regulation in health and disease. Eur J Pain. 2005 Aug;9(4):463-84. doi: 10.1016/j.ejpain.2004.11.001. Epub 2005 Jan 21.
PMID: 15979027
citation: Bailly F, Maigne JY, Genevay S, Marty M, Gandjbakhch F, Rozenberg S, Foltz V. Inflammatory pain pattern and pain with lumbar extension associated with Modic 1 changes on MRI: a prospective case-control study of 120 patients. Eur Spine J. 2014 Mar;23(3):493-7. doi: 10.1007/s00586-013-3036-6. Epub 2013 Sep 25.
PMID: 24221918
citation: Baliki MN, Geha PY, Fields HL, Apkarian AV. Predicting value of pain and analgesia: nucleus accumbens response to noxious stimuli changes in the presence of chronic pain. Neuron. 2010 Apr 15;66(1):149-60. doi: 10.1016/j.neuron.2010.03.002.
PMID: 20399736
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Chronic Pain
sharing ipd: No