<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/NCT04498338</url>
  </required_header>
  <id_info>
    <org_study_id>Interventional</org_study_id>
    <nct_id>NCT04498338</nct_id>
  </id_info>
  <brief_title>Neural Mobilization and Conventional Physical Therapy After Laminectomy</brief_title>
  <official_title>Effects of Neural Mobilization Augmented by Traditional Physical Therapy on Pain, Functional Disability and H-reflex in Patients After Lumbar Laminectomy: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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 was conducted to evaluate the effect of addition of neural mobilization to a&#xD;
      standard post-operative physical therapy program in patients with lumbar laminectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After Laminectomy, patients are suffering from many problems as pain, weakness. This study&#xD;
      was conducted on two groups of patients who underwent lumbar Laminectomy as a surgical&#xD;
      treatment for lumbar canal stenosis. The control group received TENS and strengthening&#xD;
      exercises, while the study group received neural mobilization in addition to the program that&#xD;
      was given to the control group. The outcome measures include pain intensity, nerve root&#xD;
      compression and functional level which were measured pre-treatment and post-treatment through&#xD;
      using visual analogue scale, H-reflex latency and Oswestry Disability Index (ODI)&#xD;
      respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 31, 2019</start_date>
  <completion_date type="Actual">February 27, 2020</completion_date>
  <primary_completion_date type="Actual">February 27, 2020</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>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>It was evaluated through visual analogue scale (VAS). Visual analogue scale (VAS) is a 10-cm line with a &quot;0&quot; at the left end for &quot;no pain&quot; and 10 at the right end for &quot;worst possible pain&quot;, each patient was asked to indicate on the line where his pain is in relation to the two extremes by circling the number.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nerve root compression</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>It was assessed through assessment of latency of H-reflex of S1. The participant was in prone-lying position. The active recording electrode was located on the soleus between the two heads of the gastrocnemius, while reference recording electrode was located on the Achilles tendon. The stimulation was applied at the midline in the popliteal fossa on the tibial nerve.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional ability</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>The functional ability was evaluated by Oswestery disability index (ODI). Oswestery disability index (ODI) is a valid and reliable tool for assessment of functional ability.&#xD;
The minimum value of this scale is 0. The maximum value of this scale is 100. The higher scores mean worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Laminectomy</condition>
  <arm_group>
    <arm_group_label>Neural mobilization and conventional physical therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neural mobilization combined with conventional physical therapy program (Transcutaneous electrical nerve stimulation (TENs) and exercise program) were performed three times/week for 6 successive weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional physical therapy program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional physical therapy program (Transcutaneous electrical nerve stimulation (TENs) and exercise program) was performed three times/week for 6 successive weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neural mobilization combined with conventional physical therapy program</intervention_name>
    <description>Neural mobilization of sciatic nerve combined with TENs and exercise program applied 3 times/week for successive 6 weeks.</description>
    <arm_group_label>Neural mobilization and conventional physical therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional physical therapy program</intervention_name>
    <description>TENs and exercise program applied 3 times/week for successive 6 weeks.</description>
    <arm_group_label>Conventional physical therapy program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged from 35-50 years.&#xD;
&#xD;
          -  Underwent lumbar laminectomy of one or two levels.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had arthritis in the joints of the lower limbs (which would limit&#xD;
             walking).&#xD;
&#xD;
          -  Patients who had tumors, fractures or infections of the spine.&#xD;
&#xD;
          -  Patients who had diabetes mellitus.&#xD;
&#xD;
          -  Patients who had polyneuropathy.&#xD;
&#xD;
          -  Patients who had evidence of spinal cord compression.&#xD;
&#xD;
          -  Patients who had previous spinal surgery.&#xD;
&#xD;
          -  Patients who had spinal stability problems (e.g. spondilo-listhesis, spondilolysis).&#xD;
&#xD;
          -  Patients who had sensory loss.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moussa A Sharaf, Assist Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University, Egypt</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Khalid Z Fouda, Assist Prof</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Moussa Abdelfattah Youssif Sharaf</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT04498338/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04498338
org study id: Interventional
nct id: NCT04498338
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was conducted to evaluate the effect of addition of neural mobilization to a
      standard post-operative physical therapy program in patients with lumbar laminectomy.
After Laminectomy, patients are suffering from many problems as pain, weakness. This study
      was conducted on two groups of patients who underwent lumbar Laminectomy as a surgical
      treatment for lumbar canal stenosis. The control group received TENS and strengthening
      exercises, while the study group received neural mobilization in addition to the program that
      was given to the control group. The outcome measures include pain intensity, nerve root
      compression and functional level which were measured pre-treatment and post-treatment through
      using visual analogue scale, H-reflex latency and Oswestry Disability Index (ODI)
      respectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain intensity
time frame: Up to 6 weeks
description: It was evaluated through visual analogue scale (VAS). Visual analogue scale (VAS) is a 10-cm line with a "0" at the left end for "no pain" and 10 at the right end for "worst possible pain", each patient was asked to indicate on the line where his pain is in relation to the two extremes by circling the number.
measure: Nerve root compression
time frame: Up to 6 weeks
description: It was assessed through assessment of latency of H-reflex of S1. The participant was in prone-lying position. The active recording electrode was located on the soleus between the two heads of the gastrocnemius, while reference recording electrode was located on the Achilles tendon. The stimulation was applied at the midline in the popliteal fossa on the tibial nerve.
measure: Functional ability
time frame: Up to 6 weeks
description: The functional ability was evaluated by Oswestery disability index (ODI). Oswestery disability index (ODI) is a valid and reliable tool for assessment of functional ability.
The minimum value of this scale is 0. The maximum value of this scale is 100. The higher scores mean worse outcome.
arm group label: Neural mobilization and conventional physical therapy
arm group type: Experimental
description: Neural mobilization combined with conventional physical therapy program (Transcutaneous electrical nerve stimulation (TENs) and exercise program) were performed three times/week for 6 successive weeks.
arm group label: Conventional physical therapy program
arm group type: Active Comparator
description: Conventional physical therapy program (Transcutaneous electrical nerve stimulation (TENs) and exercise program) was performed three times/week for 6 successive weeks.
intervention type: Other
intervention name: Neural mobilization combined with conventional physical therapy program
description: Neural mobilization of sciatic nerve combined with TENs and exercise program applied 3 times/week for successive 6 weeks.
arm group label: Neural mobilization and conventional physical therapy
intervention type: Other
intervention name: Conventional physical therapy program
description: TENs and exercise program applied 3 times/week for successive 6 weeks.
arm group label: Conventional physical therapy program
criteria: 
gender: All
minimum age: 35 Years
maximum age: 50 Years
healthy volunteers: No
last name: Moussa A Sharaf, Assist Prof
role: Principal Investigator
affiliation: Cairo University, Egypt
last name: Khalid Z Fouda, Assist Prof
role: Study Director
affiliation: Cairo University, Egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Moussa Abdelfattah Youssif Sharaf
investigator title: Assistant Professor
sharing ipd: No
ipd description: There is not a plan to make IPD available.
provided document: 