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/NCT06040047</url>
    </required_header>
    <id_info>
      <org_study_id>012/002739</org_study_id>
      <nct_id>NCT06040047</nct_id>
    </id_info>
    <brief_title>Prediction of Cervical Radiculopathy Success With PNF and Mobilization</brief_title>
    <official_title>Identifying Patients With Cervical Radiculopathy Responding to Proprioceptive Neuromuscular Facilitation Exercises Combined With Passive Cervical Mobilization: Clinical Prediction Rule</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo 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 goal of this predictive interventional study is todetrmine clinical predictors for&#xD;
        success with combined proprioceptive neuromusclualr faciitaion (PNF) and passive mobilization&#xD;
        ain patients with cervical radiculopathy (CR).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will answer the question, what are the factors affecting success with PNF and&#xD;
        mobilization for patients with CR? No control group. The goal of this new study is to see the&#xD;
        effect of age, duration of symptoms, forward posture angle and neck disability index response&#xD;
        to passive mobilization combined with the PNF technique&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</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>Cervical pain</measure>
      <time_frame>6 weeks</time_frame>
      <description>Score on numeric pain rating scale (points)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cervical disability</measure>
      <time_frame>6 weeks</time_frame>
      <description>Disability will be measured with Northwick Park neck pain Questionnaire.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cervical proprioception</measure>
      <time_frame>6 weeks</time_frame>
      <description>Cervical joint position error will be measured with laser pointer.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Cervical Radiculopathy</condition>
    <arm_group>
      <arm_group_label>PNF plus mobilization</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This single group will receive passive mobilization and proprioceptive neuromuscular facilitation for cervical region.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Proprioceptive neuromuscular facilitation</intervention_name>
      <description>Contract relax technique for each neck motion for three repetitions.</description>
      <arm_group_label>PNF plus mobilization</arm_group_label>
      <other_name>PNF</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Passive mobilization</intervention_name>
      <description>To restore normal joint play, postero-anterior passive joint mobilization of cervical spine segments and cervicothoracic junction in limited motion will be applied.</description>
      <arm_group_label>PNF plus mobilization</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants with cervical radiculopathy.&#xD;
  &#xD;
            -  Age ranges between 40 and 60 years old.&#xD;
  &#xD;
            -  Minimum score (3 out of 10-point) on a visual analog scale (VAS)&#xD;
  &#xD;
            -  Orthopedic clinical confirmation reveals a history of neck pain.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Whiplash injury.&#xD;
  &#xD;
            -  Previous Cervical surgery.&#xD;
  &#xD;
            -  Pain less than three months.&#xD;
  &#xD;
            -  Mechanical and non-specific neck pain.&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
            -  Bilateral arm pain.&#xD;
  &#xD;
            -  Inflammatory arthritides.&#xD;
  &#xD;
            -  Osteoporosis.&#xD;
  &#xD;
            -  Symptoms of vertebrobasilar insufficiency.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmed ElMelhat, Phd</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ElMelhat, PhD</last_name>
      <phone>01112595022</phone>
      <email>ahmedelmelhat@pt.cu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>ME</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>ME Shalash</last_name>
        <phone>01115504972</phone>
        <email>adelmotawea123@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Ahmed ElMelhat</investigator_full_name>
      <investigator_title>lecturer, orthopedic physiotherapy department</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Radiculopathy</mesh_term>
    </condition_browse>
    <!-- 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/NCT06040047
  org study id: 012/002739
  nct id: NCT06040047
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this predictive interventional study is todetrmine clinical predictors for
        success with combined proprioceptive neuromusclualr faciitaion (PNF) and passive mobilization
        ain patients with cervical radiculopathy (CR).
  This study will answer the question, what are the factors affecting success with PNF and
        mobilization for patients with CR? No control group. The goal of this new study is to see the
        effect of age, duration of symptoms, forward posture angle and neck disability index response
        to passive mobilization combined with the PNF technique
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Cervical pain
  time frame: 6 weeks
  description: Score on numeric pain rating scale (points)
  measure: Cervical disability
  time frame: 6 weeks
  description: Disability will be measured with Northwick Park neck pain Questionnaire.
  measure: Cervical proprioception
  time frame: 6 weeks
  description: Cervical joint position error will be measured with laser pointer.
  arm group label: PNF plus mobilization
  arm group type: Experimental
  description: This single group will receive passive mobilization and proprioceptive neuromuscular facilitation for cervical region.
  intervention type: Other
  intervention name: Proprioceptive neuromuscular facilitation
  description: Contract relax technique for each neck motion for three repetitions.
  arm group label: PNF plus mobilization
  other name: PNF
  intervention type: Other
  intervention name: Passive mobilization
  description: To restore normal joint play, postero-anterior passive joint mobilization of cervical spine segments and cervicothoracic junction in limited motion will be applied.
  arm group label: PNF plus mobilization
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Ahmed ElMelhat, Phd
  role: Principal Investigator
  affiliation: Cairo University
  last name: ElMelhat, PhD
  phone: 01112595022
  email: ahmedelmelhat@pt.cu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Ahmed ElMelhat
  investigator title: lecturer, orthopedic physiotherapy department
  mesh term: Radiculopathy