<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/NCT03275233</url>
  </required_header>
  <id_info>
    <org_study_id>PCIPWPPN</org_study_id>
    <nct_id>NCT03275233</nct_id>
  </id_info>
  <brief_title>Psychiatric Comorbidities in Patients With Painful Peripheral Neuropathy</brief_title>
  <official_title>Psychiatric Comorbidities in Patient With Painful Peripheral Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Psychiatric comorbidities in patient with Painful Peripheral neuropathy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neuropathic pain has been redefined by the International Association for the Study of Pain,&#xD;
      as'' pain caused by a lesion or disease of somatosensory system''.Diabetic peripheral&#xD;
      neuropathy is the result of nerve damage in the toes, feet, and hands . Approximately 50% of&#xD;
      those diabetic peripheral neuropathy have neuropathic pain .&#xD;
&#xD;
      Patients with persistent neuropathic pain experience work disability and activity limitation,&#xD;
      with a substantial impact on their social functioning. As any chronic pain state comorbid&#xD;
      depression, anxiety and sleep disturbance are common occurring in up to one half of those&#xD;
      with painful neuropathy.&#xD;
&#xD;
      The relationship between chronic pain and cognitive function has not been adequately studied&#xD;
      and little is known about cognitive functioning in neuropathic conditions. This may be&#xD;
      because the clinicians pay more attention to psychiatric comorbidities, such as depression&#xD;
      and anxiety.Although chronic pain associated with cognitive deficits may impact on everyday&#xD;
      behaviour and interfere with emotional decision-making tasks.&#xD;
&#xD;
      In a cross-sectional survey at the Mayo clinic, the prevalence of clinician-diagnosed&#xD;
      symptomatic or painful diabetic peripheral neuropathy was 13-15% out of 78% of those with any&#xD;
      type of diabetic peripheral neuropathy . Many patients with diabetic peripheral neuropathy&#xD;
      experience neuropathic pain, typically characterized as burning, electric, sharp and shooting&#xD;
      which initially starts in both feet and may progress to involve calves, fingers, and hands&#xD;
      (stocking and glove pattern) .&#xD;
&#xD;
      Recently it has been demonstrated an association between diabetes , diabetes complication and&#xD;
      impairment of mental health and particular emphasis has been placed on the association&#xD;
      between painful diabetic sensory neuropathy with depression .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 4, 2019</start_date>
  <completion_date type="Anticipated">January 4, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 4, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Psychiatric comorbidities in diabetic patients with painful(symptomatic)peripheral neuropathy.</measure>
    <time_frame>6 month</time_frame>
    <description>1- Pain assessment using visual analogue scale (VAS).</description>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Painful Peripheral Neuropathy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with painful peripheral neuropathy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Any female or male diabetic patient is aged 18 years or above had diabetic peripheral&#xD;
             neuropathy.&#xD;
&#xD;
          2. patients must be able to swallow tables&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients have other comorbid psychiatric disorders or psychological troubles that is&#xD;
             not secondary to diabetic neuropathy according to clinical and psychiatric evaluation,&#xD;
&#xD;
          2. Patients have any other causes of pain condition, or had skin conditions that are&#xD;
             likely to confound the assessment of diabetic peripheral neuropathic pain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>66 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Noha Mohamed Abo Elfetoh, Professor</last_name>
    <phone>01006800910</phone>
    <email>noha_ahmed_re@yahoo.com</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>April 19, 2019</last_update_submitted>
  <last_update_submitted_qc>April 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Andrew Ibrahim Farag</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03275233
org study id: PCIPWPPN
nct id: NCT03275233
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Psychiatric comorbidities in patient with Painful Peripheral neuropathy
Neuropathic pain has been redefined by the International Association for the Study of Pain,
      as'' pain caused by a lesion or disease of somatosensory system''.Diabetic peripheral
      neuropathy is the result of nerve damage in the toes, feet, and hands . Approximately 50% of
      those diabetic peripheral neuropathy have neuropathic pain .

      Patients with persistent neuropathic pain experience work disability and activity limitation,
      with a substantial impact on their social functioning. As any chronic pain state comorbid
      depression, anxiety and sleep disturbance are common occurring in up to one half of those
      with painful neuropathy.

      The relationship between chronic pain and cognitive function has not been adequately studied
      and little is known about cognitive functioning in neuropathic conditions. This may be
      because the clinicians pay more attention to psychiatric comorbidities, such as depression
      and anxiety.Although chronic pain associated with cognitive deficits may impact on everyday
      behaviour and interfere with emotional decision-making tasks.

      In a cross-sectional survey at the Mayo clinic, the prevalence of clinician-diagnosed
      symptomatic or painful diabetic peripheral neuropathy was 13-15% out of 78% of those with any
      type of diabetic peripheral neuropathy . Many patients with diabetic peripheral neuropathy
      experience neuropathic pain, typically characterized as burning, electric, sharp and shooting
      which initially starts in both feet and may progress to involve calves, fingers, and hands
      (stocking and glove pattern) .

      Recently it has been demonstrated an association between diabetes , diabetes complication and
      impairment of mental health and particular emphasis has been placed on the association
      between painful diabetic sensory neuropathy with depression .
observational model: Case-Only
time perspective: Prospective
measure: Psychiatric comorbidities in diabetic patients with painful(symptomatic)peripheral neuropathy.
time frame: 6 month
description: 1- Pain assessment using visual analogue scale (VAS).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 66 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Noha Mohamed Abo Elfetoh, Professor
phone: 01006800910
email: noha_ahmed_re@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Andrew Ibrahim Farag
investigator title: Principal Investigator
mesh term: Peripheral Nervous System Diseases
mesh term: Pain
sharing ipd: Undecided