<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/NCT04427423</url>
  </required_header>
  <id_info>
    <org_study_id>SKhan</org_study_id>
    <nct_id>NCT04427423</nct_id>
  </id_info>
  <brief_title>Positional Distraction and Stabilization Exercises in Adults With Lumbar Radiculopathy.</brief_title>
  <official_title>Experimental-controlled, Randomized, Single Blind Trial of Effectiveness of Positional Distraction With Stabilization Exercises Versus Stabilization Exercises Alone in the Management of Lumbar Radiculopathy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dow University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dow University of Health Sciences</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 evaluate the addition of positional distraction to stabilization exercises in the&#xD;
      treatment of lumbar radiculopathy in adults. Half of the patients will recieve positional&#xD;
      distraction and stabilization exercises in combination, while the other half will recieve&#xD;
      stabilization exercises only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In positioanl distraction making use of the body position to produce traction at an isolated&#xD;
      spinal level to maximally open the affected neuroforamen. It is an alternative to lumbar&#xD;
      mechanical traction.&#xD;
&#xD;
      The spinal level of vertebral level requiring traction is palpated and a soft roll is placed&#xD;
      and the patient side lies on the unaffected side. For further distraction both hips are&#xD;
      flexed until movement is noted at the spinal level needing traction.&#xD;
&#xD;
      Further, distraction applied by rotating upper trunk to opposite side of pain.&#xD;
&#xD;
      Stabilization exercises are mainly used for the stability of joints and for improving muscle&#xD;
      strength.&#xD;
&#xD;
      The first step of lumbar stabilization exercises are to maintain functional back positions&#xD;
      during all activities. The second step is to improve strength and endurance of the core&#xD;
      muscles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2020</start_date>
  <completion_date type="Actual">January 25, 2021</completion_date>
  <primary_completion_date type="Actual">December 12, 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>
    <intervention_model_description>All the patients will be randomly allocated into treatment and control groups 50 in experimental and 50 in control group. The treatment group will receive positional with stabilization exercises while the control group will be treated with stabilization exercises only.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The patients were blinded from the treatment groups that either he/she are in experimental or control group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Pain intensity at 8 weeks</measure>
    <time_frame>All the subjects were assessed before and after 8 weeks of treatment.</time_frame>
    <description>The pain intensity measured on self reported Visual Analogue Scale. (0 means no pain and 10 is the high intensity of pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Disability at 8 weeks</measure>
    <time_frame>All the subjects were assessed before and after 8 weeks of treatment.</time_frame>
    <description>The disability were assessed on Roland Morris Disability Questionnaire. where 0 means no disability and 24 is the high disability.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Lumbar Radiculopathy</condition>
  <arm_group>
    <arm_group_label>Positional Distraction plus Stabilization Exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment group will receive positional distraction with stabilization exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stabilization Exercise group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>control group will be treated with stabilization exercises only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>physical therapy treatment</intervention_name>
    <description>the experimental group received positional distraction plus stabilization exercises and the control group received stabilization exercises only.</description>
    <arm_group_label>Positional Distraction plus Stabilization Exercise group</arm_group_label>
    <arm_group_label>Stabilization Exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of lumbar radiculopathy&#xD;
&#xD;
          -  Age limit 30-50 years&#xD;
&#xD;
          -  Both males and females&#xD;
&#xD;
          -  Pain history more than 12 weeks but less than one year&#xD;
&#xD;
          -  Patient having lumbar disc bulge at maximum two adjacent levels&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any type of tumor and infection in the spine&#xD;
&#xD;
          -  Spondylolisthesis at L4- L5, L5-S1&#xD;
&#xD;
          -  Fracture of the lumbar spine&#xD;
&#xD;
          -  Sciatica other than lumbar region (piriformis syndrome)&#xD;
&#xD;
          -  Acute cardiopulmonary conditions&#xD;
&#xD;
          -  Morbid obesity (BMI &amp;gt; 30)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>IPMR DUHS</last_name>
    <role>Study Director</role>
    <affiliation>Dow University of Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dow University of Health Sciences</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>74200</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>April 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>February 21, 2021</last_update_submitted>
  <last_update_submitted_qc>February 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2021</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>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04427423
org study id: SKhan
nct id: NCT04427423
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluate the addition of positional distraction to stabilization exercises in the
      treatment of lumbar radiculopathy in adults. Half of the patients will recieve positional
      distraction and stabilization exercises in combination, while the other half will recieve
      stabilization exercises only.
In positioanl distraction making use of the body position to produce traction at an isolated
      spinal level to maximally open the affected neuroforamen. It is an alternative to lumbar
      mechanical traction.

      The spinal level of vertebral level requiring traction is palpated and a soft roll is placed
      and the patient side lies on the unaffected side. For further distraction both hips are
      flexed until movement is noted at the spinal level needing traction.

      Further, distraction applied by rotating upper trunk to opposite side of pain.

      Stabilization exercises are mainly used for the stability of joints and for improving muscle
      strength.

      The first step of lumbar stabilization exercises are to maintain functional back positions
      during all activities. The second step is to improve strength and endurance of the core
      muscles.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All the patients will be randomly allocated into treatment and control groups 50 in experimental and 50 in control group. The treatment group will receive positional with stabilization exercises while the control group will be treated with stabilization exercises only.
primary purpose: Prevention
masking: Single (Participant)
masking description: The patients were blinded from the treatment groups that either he/she are in experimental or control group.
measure: Change from baseline Pain intensity at 8 weeks
time frame: All the subjects were assessed before and after 8 weeks of treatment.
description: The pain intensity measured on self reported Visual Analogue Scale. (0 means no pain and 10 is the high intensity of pain).
measure: Change from baseline Disability at 8 weeks
time frame: All the subjects were assessed before and after 8 weeks of treatment.
description: The disability were assessed on Roland Morris Disability Questionnaire. where 0 means no disability and 24 is the high disability.
arm group label: Positional Distraction plus Stabilization Exercise group
arm group type: Experimental
description: The treatment group will receive positional distraction with stabilization exercises
arm group label: Stabilization Exercise group
arm group type: Active Comparator
description: control group will be treated with stabilization exercises only.
intervention type: Other
intervention name: physical therapy treatment
description: the experimental group received positional distraction plus stabilization exercises and the control group received stabilization exercises only.
arm group label: Positional Distraction plus Stabilization Exercise group
arm group label: Stabilization Exercise group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: No
last name: IPMR DUHS
role: Study Director
affiliation: Dow University of Health Sciences
facility: 
country: Pakistan
responsible party type: Sponsor
mesh term: Radiculopathy
sharing ipd: No