<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/NCT04505332</url>
  </required_header>
  <id_info>
    <org_study_id>20.12.07</org_study_id>
    <nct_id>NCT04505332</nct_id>
  </id_info>
  <brief_title>Back Pain and Arthroplasty in Orthopedists</brief_title>
  <official_title>Investigation of the Relationship Between Back Pain and Arthroplasty in Orthopedists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uludag University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uludag University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The relationship between arthroplasty and low back pain in orthopedists will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>back pain in orthopedists</measure>
    <time_frame>2 month</time_frame>
    <description>The relationship between arthroplasty performing and back pain in orthopaedics. Some orthopaedics perform arthroplasty every day, some perform 2 or 3 times a day. This can cause some pain in the low back due to the position during the operation. In our study, the investigators will have a survey of orthopaedics and answer some questions: How long have they been doing this job, how many arthroplasty operation they made during a day, do they have any complaints of low back pain. The investigators will try to relate back pain with their answers.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Pain, Chronic</condition>
  <condition>Back Pain</condition>
  <arm_group>
    <arm_group_label>orthopedists</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>orthopedists working actively and performing arthroplasty every day</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>arthroplasty</intervention_name>
    <description>back pain in orthopedists due to working actively and performing arthroplasty every day</description>
    <arm_group_label>orthopedists</arm_group_label>
    <other_name>back pain</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Those who have received specialization of orthopaedics and work as a orthopaedics&#xD;
             surgery.&#xD;
&#xD;
          -  Those who want to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with discomfort and operation due to the low back pain&#xD;
&#xD;
          -  Physicians in other branches&#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>Ali Erkan YENIGUL</last_name>
    <phone>05058254619</phone>
    <email>alierkanyenigul@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ali Erkan YENIGUL</name>
      <address>
        <city>Bursa</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ali Erkan YENIGUL</last_name>
      <phone>05058254619</phone>
      <phone_ext>05058254619</phone_ext>
      <email>alierkanyenigul@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uludag University</investigator_affiliation>
    <investigator_full_name>Ali Erkan YENİGUL</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>Back Pain</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/NCT04505332
org study id: 20.12.07
nct id: NCT04505332
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The relationship between arthroplasty and low back pain in orthopedists will be evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: back pain in orthopedists
time frame: 2 month
description: The relationship between arthroplasty performing and back pain in orthopaedics. Some orthopaedics perform arthroplasty every day, some perform 2 or 3 times a day. This can cause some pain in the low back due to the position during the operation. In our study, the investigators will have a survey of orthopaedics and answer some questions: How long have they been doing this job, how many arthroplasty operation they made during a day, do they have any complaints of low back pain. The investigators will try to relate back pain with their answers.
arm group label: orthopedists
arm group type: Other
description: orthopedists working actively and performing arthroplasty every day
intervention type: Procedure
intervention name: arthroplasty
description: back pain in orthopedists due to working actively and performing arthroplasty every day
arm group label: orthopedists
other name: back pain
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ali Erkan YENIGUL
phone: 05058254619
email: alierkanyenigul@hotmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Uludag University
investigator full name: Ali Erkan YENİGUL
investigator title: Principal Investigator
mesh term: Back Pain
mesh term: Chronic Pain
sharing ipd: No