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/NCT06001359</url>
    </required_header>
    <id_info>
      <org_study_id>radiculopathy</org_study_id>
      <nct_id>NCT06001359</nct_id>
    </id_info>
    <brief_title>Functional Limitation, Pain and Quality of Life in Patients With Cervical Spondylotic Radiculopathy</brief_title>
    <official_title>Functional Limitation, Pain, Disability and Quality of Life in Patients With Cervical Spondylotic Radiculopathy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karabuk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Karabuk 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>
        Radiculopathy is a neurological condition in which transmission along a spinal nerve and its&#xD;
        roots is limited or inhibited. It is most caused by spondylotic changes such as cervical disc&#xD;
        herniation leading to nerve root compression, inflammatory changes, and the formation of bony&#xD;
        prominences in this region [1]. Pain is the initial symptom and cervical radiculopathy should&#xD;
        be suspected when pain radiates from the neck to the shoulder and arm, accompanied by sensory&#xD;
        complaints and motor weakness. It is most commonly caused by spondylotic changes, such as&#xD;
        cervical disc herniation and bony prominences in this area, leading to nerve root compression&#xD;
        and inflammatory changes. Stenotic changes in the spine, which are often observed with aging,&#xD;
        can cause nerve damage and compression in individuals, causing radicular pain. However, there&#xD;
        is insufficient study in which the relationship between pain caused by cervical spondylotic&#xD;
        radiculopathy caused by stenosis and functional disability, disability and quality of life&#xD;
        due to radiculopathy in patients is insufficient. In addition, the lack of a comprehensive&#xD;
        outcome scale that evaluates the functional limitation caused by radicular pain has also led&#xD;
        to a deficiency in the evaluation of functional limitation. In this context, CRES is a newly&#xD;
        developed scale used to evaluate functional limitation associated with radicular pain. In&#xD;
        this context, in this study, it was aimed to examine the relationship between pain,&#xD;
        functional disability, disability and quality of life in patients with cervical spondylotic&#xD;
        radiculopathy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Neck Pain</measure>
      <time_frame>baseline</time_frame>
      <description>The Numeric Rating Scale measures the severity of pain. Scores range from 0 (no pain/numbness) to 10 (worst possible pain/numbness).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Funcitonal disability</measure>
      <time_frame>baseline</time_frame>
      <description>The Cervical Radiculopathy Impact Scale (CRIS) will used to determine the functional limitation. This scale includes 21 questions consisting of 3 sub-headings.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Disability</measure>
      <time_frame>baseline</time_frame>
      <description>Neck Disability Index (NDI) will used to evaluate the effect of neck pain on activities of daily living</description>
    </primary_outcome>
    <primary_outcome>
      <measure>life quality</measure>
      <time_frame>baseline</time_frame>
      <description>The EuroQol Five-Dimensions - 3-Level (EQ-5D-3L) General Quality of Life Scale will used to evaluate the quality of life of individuals</description>
    </primary_outcome>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Radiculopathy</condition>
    <condition>Elderly</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>No intervention</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          64 patients with spondylotic radiculopathy will be included.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  over 18 years of age&#xD;
  &#xD;
            -  with lateral-foraminal spinal stenosis in the cervical region&#xD;
  &#xD;
            -  with or without neck pain consistent with the diagnosis obtained from magnetic&#xD;
               resonance imaging&#xD;
  &#xD;
            -  with unilateral root symptoms such as pain, numbness, weakness in the affected limb,&#xD;
               and diagnosis based on MRI and computerized tomography&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  signs of increased ventral pressure, such as ventral osteophytes, disc calcification,&#xD;
               and ligament hypertrophy&#xD;
  &#xD;
            -  severe neurological deficits, pregnant women, spinal malignancies,&#xD;
  &#xD;
            -  those who had undergone cervical surgery in the last 12 months&#xD;
  &#xD;
            -  and those who could not cooperate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Aydın Sinan Apaydın, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Assistant Professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aydın Sinan Aydın Sinan, +905065897613</last_name>
      <phone>+905065897613</phone>
      <email>dr.sinanapaydin@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Karabuk University</name>
        <address>
          <city>Karabük</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aydın Sinan Apaydın, PhD</last_name>
        <phone>+905065897613</phone>
        <email>dr.sinanapaydin@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Thoomes EJ, Scholten-Peeters GG, de Boer AJ, Olsthoorn RA, Verkerk K, Lin C, Verhagen AP. Lack of uniform diagnostic criteria for cervical radiculopathy in conservative intervention studies: a systematic review. Eur Spine J. 2012 Aug;21(8):1459-70. doi: 10.1007/s00586-012-2297-9. Epub 2012 Apr 25.</citation>
      <PMID>22531897</PMID>
    </reference>
    <reference>
      <citation>Patel EA, Perloff MD. Radicular Pain Syndromes: Cervical, Lumbar, and Spinal Stenosis. Semin Neurol. 2018 Dec;38(6):634-639. doi: 10.1055/s-0038-1673680. Epub 2018 Dec 6.</citation>
      <PMID>30522138</PMID>
    </reference>
    <reference>
      <citation>Kelly JC, Groarke PJ, Butler JS, Poynton AR, O'Byrne JM. The natural history and clinical syndromes of degenerative cervical spondylosis. Adv Orthop. 2012;2012:393642. doi: 10.1155/2012/393642. Epub 2011 Nov 28.</citation>
      <PMID>22162812</PMID>
    </reference>
    <results_reference>
      <citation>Grasso G, Salli M, Torregrossa F. Does Hybrid Surgery Improve Quality of Life in Multilevel Cervical Degenerative Disk Disease? Five-Year Follow-up Study. World Neurosurg. 2020 Aug;140:527-533. doi: 10.1016/j.wneu.2020.03.097.</citation>
      <PMID>32797985</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Karabuk University</investigator_affiliation>
      <investigator_full_name>Aydın Sinan Apaydin</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Radiculopathy</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/NCT06001359
  org study id: radiculopathy
  nct id: NCT06001359
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Radiculopathy is a neurological condition in which transmission along a spinal nerve and its
        roots is limited or inhibited. It is most caused by spondylotic changes such as cervical disc
        herniation leading to nerve root compression, inflammatory changes, and the formation of bony
        prominences in this region [1]. Pain is the initial symptom and cervical radiculopathy should
        be suspected when pain radiates from the neck to the shoulder and arm, accompanied by sensory
        complaints and motor weakness. It is most commonly caused by spondylotic changes, such as
        cervical disc herniation and bony prominences in this area, leading to nerve root compression
        and inflammatory changes. Stenotic changes in the spine, which are often observed with aging,
        can cause nerve damage and compression in individuals, causing radicular pain. However, there
        is insufficient study in which the relationship between pain caused by cervical spondylotic
        radiculopathy caused by stenosis and functional disability, disability and quality of life
        due to radiculopathy in patients is insufficient. In addition, the lack of a comprehensive
        outcome scale that evaluates the functional limitation caused by radicular pain has also led
        to a deficiency in the evaluation of functional limitation. In this context, CRES is a newly
        developed scale used to evaluate functional limitation associated with radicular pain. In
        this context, in this study, it was aimed to examine the relationship between pain,
        functional disability, disability and quality of life in patients with cervical spondylotic
        radiculopathy.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Neck Pain
  time frame: baseline
  description: The Numeric Rating Scale measures the severity of pain. Scores range from 0 (no pain/numbness) to 10 (worst possible pain/numbness).
  measure: Funcitonal disability
  time frame: baseline
  description: The Cervical Radiculopathy Impact Scale (CRIS) will used to determine the functional limitation. This scale includes 21 questions consisting of 3 sub-headings.
  measure: Disability
  time frame: baseline
  description: Neck Disability Index (NDI) will used to evaluate the effect of neck pain on activities of daily living
  measure: life quality
  time frame: baseline
  description: The EuroQol Five-Dimensions - 3-Level (EQ-5D-3L) General Quality of Life Scale will used to evaluate the quality of life of individuals
  intervention type: Other
  intervention name: No intervention
  description: No intervention
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Aydın Sinan Apaydın, PhD
  role: Study Director
  affiliation: Assistant Professor
  last name: Aydın Sinan Aydın Sinan, +905065897613
  phone: +905065897613
  email: dr.sinanapaydin@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Thoomes EJ, Scholten-Peeters GG, de Boer AJ, Olsthoorn RA, Verkerk K, Lin C, Verhagen AP. Lack of uniform diagnostic criteria for cervical radiculopathy in conservative intervention studies: a systematic review. Eur Spine J. 2012 Aug;21(8):1459-70. doi: 10.1007/s00586-012-2297-9. Epub 2012 Apr 25.
  PMID: 22531897
  citation: Patel EA, Perloff MD. Radicular Pain Syndromes: Cervical, Lumbar, and Spinal Stenosis. Semin Neurol. 2018 Dec;38(6):634-639. doi: 10.1055/s-0038-1673680. Epub 2018 Dec 6.
  PMID: 30522138
  citation: Kelly JC, Groarke PJ, Butler JS, Poynton AR, O'Byrne JM. The natural history and clinical syndromes of degenerative cervical spondylosis. Adv Orthop. 2012;2012:393642. doi: 10.1155/2012/393642. Epub 2011 Nov 28.
  PMID: 22162812
  citation: Grasso G, Salli M, Torregrossa F. Does Hybrid Surgery Improve Quality of Life in Multilevel Cervical Degenerative Disk Disease? Five-Year Follow-up Study. World Neurosurg. 2020 Aug;140:527-533. doi: 10.1016/j.wneu.2020.03.097.
  PMID: 32797985
  responsible party type: Principal Investigator
  investigator affiliation: Karabuk University
  investigator full name: Aydın Sinan Apaydin
  investigator title: Doctor
  mesh term: Radiculopathy
  sharing ipd: No