<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/NCT03838315</url>
  </required_header>
  <id_info>
    <org_study_id>IIRS-IUISB/MphilOPT/002</org_study_id>
    <nct_id>NCT03838315</nct_id>
  </id_info>
  <brief_title>Effects of Neural Mobilization With or Without Soft Tissue Mobilization in Cervical Radiculopathy</brief_title>
  <official_title>Effects of Neural Mobilization With or Without Soft Tissue Mobilization in Cervical Radiculopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isra University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isra University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate Effects of Neural Mobilization with or without Soft Tissue&#xD;
      Mobilization in Cervical Radiculopathy, half of the subjects will receive treatment of Neural&#xD;
      Mobilization along with Soft Tissue Mobilization whereas half of the subjects will receive&#xD;
      only Neural Mobilization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neural mobilization and Soft Tissue Mobilization both treatments are used to treat Cervical&#xD;
      Radiculopathy but they work differently.&#xD;
&#xD;
      Neural mobilization technique is different for all 3 nerves i.e Radial, ulnar and median.&#xD;
      Neural Mobilization Technique target the single nerve which is being compressed and showing&#xD;
      symptoms.&#xD;
&#xD;
      Soft Tissue Mobilization include traction which decompresses the nerve and stretches the&#xD;
      surrounding muscles along with help to reduce pain and tingling sensation. whereas hot pack&#xD;
      helps to increase blood circulation and warm up muscles and isometric exercises provide&#xD;
      strengthening and build endurance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 20, 2019</start_date>
  <completion_date type="Anticipated">June 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 20, 2019</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>
    <intervention_model_description>Subjects will be assigned randomly into two groups: Neural Mobilization with Soft tissue mobilization and Neural mobilization without Soft tissue mobilization.A coin will be flipped at start of data collection for the first patient to be assigned odd number and included in Neural mobilization with Soft tissue mobilization group. Later on odd and even numbered subjects will be included in specific group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neck Pain Numeric Scale</measure>
    <time_frame>4weeks</time_frame>
    <description>Pain intensity in one of the upper limb is measured by Numeric pain scale in which &quot;0&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neck Disability Index</measure>
    <time_frame>4weeks</time_frame>
    <description>Neck disability index scale used to measure ability to manage neck pain in everyday life in terms of: Pain intensity, Personal care, Lifting, Reading, Headaches, and Concentration. In which &quot;0&quot; shows disability and &quot;5&quot; shows normal.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cervical Radiculopathy</condition>
  <arm_group>
    <arm_group_label>Neural Mobilization with Soft Tissue Mobilization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neural Mobilization with Soft Tissue Mobilization group will be assessed by spurling's test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Neural mobilization Techniques which involve Median, Radial and Ulnar Nerve Mobilization and Post Isometric Relaxation Techniques.&#xD;
Frequency for Neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 40mints each session)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neural mobilization without Soft Tissue Mobilization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neural Mobilization without Soft Tissue Mobilization group will be assessed by spurling's test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Neural Mobilization Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 30mints each session)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neural Mobilization with Soft Tissue Mobilization</intervention_name>
    <description>Cervical Traction for 10mints 7%of body weight with 7 second hold time and 5 second rest time.&#xD;
Hot Pack for 10mints. Neural mobilization technique includes Median, Radial and Ulnar nerve mobilization. Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 10minute.&#xD;
•Post isometric relaxation technique</description>
    <arm_group_label>Neural Mobilization with Soft Tissue Mobilization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neural Mobilization without Soft Tissue Mobilization</intervention_name>
    <description>Cervical Traction for 10mints 7%of body weight with 7 second hold time and 5 second rest time.&#xD;
Hot Pack&#xD;
Neural mobilization technique includes Median, Radial and Ulnar nerve mobilization Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 10minute.</description>
    <arm_group_label>Neural mobilization without Soft Tissue Mobilization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with age 18 to 55years&#xD;
&#xD;
          -  Patients having pain more than 3months&#xD;
&#xD;
          -  Radiating pain in one of the upper limb&#xD;
&#xD;
          -  Spurling's test positive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Traumatic injury of upper limb or cervical spine&#xD;
&#xD;
          -  Vertebral artery test positive(dizziness, vomiting, diplopia, drop attacks etc)&#xD;
&#xD;
          -  Patient asymptomatic for pain but symptomatic for tingling and paraesthesia&#xD;
&#xD;
          -  Circulatory disturbance of upper extremity&#xD;
&#xD;
          -  Known history of high level of spinal cord injury and malignancy&#xD;
&#xD;
          -  Thoracic Outlet syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Noor Ul Ain, MPhilOPT</last_name>
    <phone>0333-5292822</phone>
    <email>Noorabid2015@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Waqar Ahmed Awan, Ph D Rehab</last_name>
    <phone>03335348846</phone>
    <email>wawan01@hotmail.com</email>
  </overall_contact_backup>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 9, 2019</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isra University</investigator_affiliation>
    <investigator_full_name>Noor Abid</investigator_full_name>
    <investigator_title>Research Associate</investigator_title>
  </responsible_party>
  <keyword>Cervical Radiculopathy,</keyword>
  <keyword>Neural Mobilizations,</keyword>
  <keyword>Soft Tissue Mobilization</keyword>
  <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>


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/NCT03838315
org study id: IIRS-IUISB/MphilOPT/002
nct id: NCT03838315
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will evaluate Effects of Neural Mobilization with or without Soft Tissue
      Mobilization in Cervical Radiculopathy, half of the subjects will receive treatment of Neural
      Mobilization along with Soft Tissue Mobilization whereas half of the subjects will receive
      only Neural Mobilization.
Neural mobilization and Soft Tissue Mobilization both treatments are used to treat Cervical
      Radiculopathy but they work differently.

      Neural mobilization technique is different for all 3 nerves i.e Radial, ulnar and median.
      Neural Mobilization Technique target the single nerve which is being compressed and showing
      symptoms.

      Soft Tissue Mobilization include traction which decompresses the nerve and stretches the
      surrounding muscles along with help to reduce pain and tingling sensation. whereas hot pack
      helps to increase blood circulation and warm up muscles and isometric exercises provide
      strengthening and build endurance.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be assigned randomly into two groups: Neural Mobilization with Soft tissue mobilization and Neural mobilization without Soft tissue mobilization.A coin will be flipped at start of data collection for the first patient to be assigned odd number and included in Neural mobilization with Soft tissue mobilization group. Later on odd and even numbered subjects will be included in specific group.
primary purpose: Treatment
masking: None (Open Label)
measure: Neck Pain Numeric Scale
time frame: 4weeks
description: Pain intensity in one of the upper limb is measured by Numeric pain scale in which "0"
measure: Neck Disability Index
time frame: 4weeks
description: Neck disability index scale used to measure ability to manage neck pain in everyday life in terms of: Pain intensity, Personal care, Lifting, Reading, Headaches, and Concentration. In which "0" shows disability and "5" shows normal.
arm group label: Neural Mobilization with Soft Tissue Mobilization
arm group type: Experimental
description: Neural Mobilization with Soft Tissue Mobilization group will be assessed by spurling's test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Neural mobilization Techniques which involve Median, Radial and Ulnar Nerve Mobilization and Post Isometric Relaxation Techniques.
Frequency for Neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 40mints each session)
arm group label: Neural mobilization without Soft Tissue Mobilization
arm group type: Active Comparator
description: Neural Mobilization without Soft Tissue Mobilization group will be assessed by spurling's test and than will involved in treatment protocol i.e Cervical Traction, Hot packs, Neural Mobilization Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 30mints each session)
intervention type: Other
intervention name: Neural Mobilization with Soft Tissue Mobilization
description: Cervical Traction for 10mints 7%of body weight with 7 second hold time and 5 second rest time.
Hot Pack for 10mints. Neural mobilization technique includes Median, Radial and Ulnar nerve mobilization. Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 10minute.
•Post isometric relaxation technique
arm group label: Neural Mobilization with Soft Tissue Mobilization
intervention type: Other
intervention name: Neural Mobilization without Soft Tissue Mobilization
description: Cervical Traction for 10mints 7%of body weight with 7 second hold time and 5 second rest time.
Hot Pack
Neural mobilization technique includes Median, Radial and Ulnar nerve mobilization Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 10minute.
arm group label: Neural mobilization without Soft Tissue Mobilization
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Noor Ul Ain, MPhilOPT
phone: 0333-5292822
email: Noorabid2015@gmail.com
last name: Waqar Ahmed Awan, Ph D Rehab
phone: 03335348846
email: wawan01@hotmail.com
responsible party type: Principal Investigator
investigator affiliation: Isra University
investigator full name: Noor Abid
investigator title: Research Associate
mesh term: Radiculopathy