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/NCT06028958</url>
    </required_header>
    <id_info>
      <org_study_id>REC-UOL-487-08-2023</org_study_id>
      <nct_id>NCT06028958</nct_id>
    </id_info>
    <brief_title>Global Postural Re-Education And Neck Isometric Exercises In Cervical Radiculopathy RADICULOPATHY</brief_title>
    <official_title>Effects Of Global Postural Re-Education And Neck Isometric Exercises In Patients With Cervical Radiculopathy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Lahore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Lahore</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Cervical radiculopathy is a common neurological disorder that is caused by compression of the&#xD;
        nerve, inflammation of nerve roots, or space-occupying lesions. Cervical radiculopathy is the&#xD;
        most common health-related problem worldwide. The conservative approach like education,&#xD;
        specific exercises, and spinal manipulation is usually given for chronic cases with good&#xD;
        outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cervical Radiculopathy is a condition in which a nerve is entrapped between the bones and&#xD;
        causes numbness and tingling. Neck isometric exercises are a basic treatment plan for&#xD;
        strength training. Global postural reeducation is a technique the manual cervical traction&#xD;
        along with body alignment that helps to reduce symptoms more rapidly. This whole procedure is&#xD;
        completed more easily, without a machine and satisfying for the patient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The outcome accessor will be unaware of the treatment group.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pain Intensity</measure>
      <time_frame>Pain intensity will be measured at baseline, and change in pain intensity will be measured at 1st week, and 2nd week of treatment..</time_frame>
      <description>Neck pain will be assessed utilizing the 10cm Visual Analogue Scale. The members will register their current pain level by selecting any from 0(no pain) to 10(unbearable pain) presented ahead a level line.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Level of Functional Disability</measure>
      <time_frame>Change in Functional Status will be measured at baseline, at first week, and at second week of treatment.</time_frame>
      <description>The level of Functional disability will be measured by using the neck disability index. It contains 10 readings including pain intensity, personal care, headache, lifting, reading, concentration, work, driving sleeping, and recreation. The questions are measured on a 6-point scale from 0 (no disability) to 5 (full disability). The numeric response for each item is summed for a score varying from 0 to 50.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">85</enrollment>
    <condition>Cervical Radiculopathy</condition>
    <arm_group>
      <arm_group_label>Neck Isometrics Exercises</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group of participants will receive neck isometric exercises along with routine physical therapy and a hot pack. In this regimen, the patient is commanded to apply minimal resistance on the physiotherapist's hand in front, back, and lateral positions. This resistance is applied for 10 sec with a 15 sec hold with 10-15 repetitions. The protocol will be given to the participants for two weeks. Each session will be of 40 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Global Posture Re-Education</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group of participants will receive the Global Posture Re-Education technique with a hot pack. The protocol will be given to the participants for two weeks (1 session on an alternative day with the home plan). Each session will be of 40 minutes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Neck Isometrics Exercises</intervention_name>
      <description>Isometric exercises are tightening (contractions) of a specific muscle or group of muscles. During isometric exercises, the muscle doesn't noticeably change length. The affected joint also doesn't move. Isometric exercises help maintain strength.</description>
      <arm_group_label>Neck Isometrics Exercises</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Global Posture Re-Education</intervention_name>
      <description>Global postural rehabilitation (GPR) is an approach that considers the body in its overall aspect. This technique aims to relax the envelope of the muscles (fascia) while relaxing the muscle chains to reduce the strain on the joints. The end result is a more suitable posture and less pain.</description>
      <arm_group_label>Global Posture Re-Education</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 18 to 35 years.&#xD;
  &#xD;
            2. Both genders, Males and females&#xD;
  &#xD;
            3. One-sided upper limb pain or numbness&#xD;
  &#xD;
            4. Any 2 out of 4 tests are positive Spurling test, Distraction test, Ipsilateral&#xD;
               cervical traction test, and Upper Limb test&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Bilateral upper limb pain&#xD;
  &#xD;
            2. Previous history of cervical surgery&#xD;
  &#xD;
            3. Cervical spine&#xD;
  &#xD;
            4. Injection therapy in the past 2 weeks&#xD;
  &#xD;
            5. Being Pregnant women&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ashfaq Dr Ahmed, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>The University of Lahore</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bushra Umer, MS</last_name>
      <phone>+923089266552</phone>
      <email>bushraumer05@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ayesha Jamil, M.Phil</last_name>
      <phone>+923244481031</phone>
      <email>ayesha.jamil@uipt.uol.edu.pk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Lahore</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>5400</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bushra Umer, MS</last_name>
        <phone>+923089266552</phone>
        <email>bushraumer05@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Ayesha Jamil, M.Phil</last_name>
        <phone>+923244481031</phone>
        <email>ayesha.jamil@uipt.uol.edu.pk</email>
      </contact_backup>
      <investigator>
        <last_name>Bushra Umer, MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</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>Radiculopathy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>It will be shared soon after publication</ipd_time_frame>
    </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/NCT06028958
  org study id: REC-UOL-487-08-2023
  nct id: NCT06028958
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Cervical radiculopathy is a common neurological disorder that is caused by compression of the
        nerve, inflammation of nerve roots, or space-occupying lesions. Cervical radiculopathy is the
        most common health-related problem worldwide. The conservative approach like education,
        specific exercises, and spinal manipulation is usually given for chronic cases with good
        outcomes.
  Cervical Radiculopathy is a condition in which a nerve is entrapped between the bones and
        causes numbness and tingling. Neck isometric exercises are a basic treatment plan for
        strength training. Global postural reeducation is a technique the manual cervical traction
        along with body alignment that helps to reduce symptoms more rapidly. This whole procedure is
        completed more easily, without a machine and satisfying for the patient.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: The outcome accessor will be unaware of the treatment group.
  measure: Pain Intensity
  time frame: Pain intensity will be measured at baseline, and change in pain intensity will be measured at 1st week, and 2nd week of treatment..
  description: Neck pain will be assessed utilizing the 10cm Visual Analogue Scale. The members will register their current pain level by selecting any from 0(no pain) to 10(unbearable pain) presented ahead a level line.
  measure: Level of Functional Disability
  time frame: Change in Functional Status will be measured at baseline, at first week, and at second week of treatment.
  description: The level of Functional disability will be measured by using the neck disability index. It contains 10 readings including pain intensity, personal care, headache, lifting, reading, concentration, work, driving sleeping, and recreation. The questions are measured on a 6-point scale from 0 (no disability) to 5 (full disability). The numeric response for each item is summed for a score varying from 0 to 50.
  arm group label: Neck Isometrics Exercises
  arm group type: Active Comparator
  description: This group of participants will receive neck isometric exercises along with routine physical therapy and a hot pack. In this regimen, the patient is commanded to apply minimal resistance on the physiotherapist's hand in front, back, and lateral positions. This resistance is applied for 10 sec with a 15 sec hold with 10-15 repetitions. The protocol will be given to the participants for two weeks. Each session will be of 40 minutes.
  arm group label: Global Posture Re-Education
  arm group type: Experimental
  description: This group of participants will receive the Global Posture Re-Education technique with a hot pack. The protocol will be given to the participants for two weeks (1 session on an alternative day with the home plan). Each session will be of 40 minutes.
  intervention type: Other
  intervention name: Neck Isometrics Exercises
  description: Isometric exercises are tightening (contractions) of a specific muscle or group of muscles. During isometric exercises, the muscle doesn't noticeably change length. The affected joint also doesn't move. Isometric exercises help maintain strength.
  arm group label: Neck Isometrics Exercises
  intervention type: Other
  intervention name: Global Posture Re-Education
  description: Global postural rehabilitation (GPR) is an approach that considers the body in its overall aspect. This technique aims to relax the envelope of the muscles (fascia) while relaxing the muscle chains to reduce the strain on the joints. The end result is a more suitable posture and less pain.
  arm group label: Global Posture Re-Education
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: No
  last name: Ashfaq Dr Ahmed, PhD
  role: Study Chair
  affiliation: The University of Lahore
  last name: Bushra Umer, MS
  phone: +923089266552
  email: bushraumer05@gmail.com
  last name: Ayesha Jamil, M.Phil
  phone: +923244481031
  email: ayesha.jamil@uipt.uol.edu.pk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Radiculopathy
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd time frame: It will be shared soon after publication