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/NCT06010381</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/003370</org_study_id>
      <nct_id>NCT06010381</nct_id>
    </id_info>
    <brief_title>Muscle Energy Technique Versus Maitland Mobilization on Shoulder Pain and Disability</brief_title>
    <official_title>Muscle Energy Technique Versus Maitland Mobilization on Shoulder Pain and Disability After Neck Dissection Surgeries.</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>No</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>
        The purpose of this study was to investigate the effect of muscle energy technique versus&#xD;
        Maitland's mobilization on shoulder pain and disability after neck dissection surgeries.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Thirty patients with shoulder pain and limited ROM post-neck dissection surgeries&#xD;
        participated in this study. Patients were subdivided into two groups, fifteen patients in&#xD;
        each group. Group A received the muscle energy technique and group B received Maitland's&#xD;
        mobilization.&#xD;
  &#xD;
        Data obtained from both groups regarding Visual Analogue Scale (VAS), The Shoulder Pain and&#xD;
        Disability Index (SPADI), and shoulder flexion, abduction, and external ROM were&#xD;
        statistically analyzed and compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">November 1, 2021</start_date>
    <completion_date type="Anticipated">September 13, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 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>
      <intervention_model_description>Patients were subdivided into two groups, fifteen patients in each group. Group A received the muscle energy technique and group B received Maitland's mobilization.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual analogue scale (VAS)</measure>
      <time_frame>Change from baseline at four weeks after the intervention</time_frame>
      <description>A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiology and clinical research to measure the intensity or frequency of various symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The SPADI (Shoulder Pain and Disability Index)</measure>
      <time_frame>Change from baseline at four weeks after the intervention</time_frame>
      <description>It is a self-reported questionnaire consisting of 13 items divided in two parts: pain and disability sub-scale.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Shoulder active range of motion</measure>
      <time_frame>Change from baseline at four weeks after the intervention</time_frame>
      <description>Through using the universal goniometer to measure the shoulder flexion, abduction and, external rotation.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Neck Cancer</condition>
    <condition>Mobility Limitation</condition>
    <condition>Pain Syndrome</condition>
    <condition>Shoulder Pain</condition>
    <condition>Surgery</condition>
    <arm_group>
      <arm_group_label>Muscle energy technique</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group includes 15 patients who received muscle energy technique post-surgery in addition to traditional shoulder exercise, 3 sessions/week for four weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Maitland mobilization</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group includes 15 patients who received mobilization in addition to traditional shoulder exercise, 3 sessions/week for four weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Muscle energy technique</intervention_name>
      <description>It was applied on the shoulder flexion and the external rotation. An isometric contraction of the agonist muscle (the muscle which requires stretching) for 7 seconds with gentle muscle contraction to avoid the risk of increasing the muscle tone. This contraction started just short of the restrictive barrier. After that, the patient is asked to relax for 2-3 seconds and then the therapist stretches the contracted muscle in the opposite direction for 30 seconds. This is repeated three repetitions for each muscle.</description>
      <arm_group_label>Muscle energy technique</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Maitland mobilization</intervention_name>
      <description>At the start of each session, the physical therapist examined the patient's ROM in all directions to obtain information about the end-range position and the end feel of the glenohumeral joint. Start with rhythmic mid-range mobilization with the patient in a supine position. The therapist's hands are placed close to the glenohumeral joint, and the humerus is brought into a position of maximal flexion in the sagittal plane. After 10 to 15 repetitions of intensive mobilization techniques in this end-range position, the direction of mobilization will be altered by varying the plane of elevation or by varying the degree of rotation. When alternating the direction of mobilization, other movements such as gliding techniques and distraction in that joint position were (inferior gliding, anterior gliding, and posterior gliding).</description>
      <arm_group_label>Maitland mobilization</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional shoulder exercise</intervention_name>
      <description>Traditional shoulder exercises in the form of shoulder range of motion exercises, stretching exercises and, scapular stabilization.</description>
      <arm_group_label>Maitland mobilization</arm_group_label>
      <arm_group_label>Muscle energy technique</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age range between 25-70 years.&#xD;
  &#xD;
            -  Male and female patients participated in the study.&#xD;
  &#xD;
            -  All patients had shoulder pain following different NDS&#xD;
  &#xD;
            -  All patients had no previous shoulder pain.&#xD;
  &#xD;
            -  All patients enrolled in the study had their informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous shoulder pain from any other causes.&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
            -  Epileptics.&#xD;
  &#xD;
            -  Radiotherapy.&#xD;
  &#xD;
            -  Chemotherapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shaimaa MA El Sayeh, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Lecturer at Faculty of Physical Therapy, Cairo University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Shaimaa Mohamed Ahmed El Sayeh</name>
        <address>
          <city>Cairo</city>
          <zip>02</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Shaimaa Mohamed Ahmed Elsayeh</investigator_full_name>
      <investigator_title>Lecturer of Physical Therapy</investigator_title>
    </responsible_party>
    <keyword>Muscle energy technique</keyword>
    <keyword>Maitland's mobilization</keyword>
    <keyword>shoulder pain and disability</keyword>
    <keyword>neck dissection surgeries</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Shoulder Pain</mesh_term>
      <mesh_term>Mobility Limitation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06010381
  org study id: P.T.REC/012/003370
  nct id: NCT06010381
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study was to investigate the effect of muscle energy technique versus
        Maitland's mobilization on shoulder pain and disability after neck dissection surgeries.
  Thirty patients with shoulder pain and limited ROM post-neck dissection surgeries
        participated in this study. Patients were subdivided into two groups, fifteen patients in
        each group. Group A received the muscle energy technique and group B received Maitland's
        mobilization.
  
        Data obtained from both groups regarding Visual Analogue Scale (VAS), The Shoulder Pain and
        Disability Index (SPADI), and shoulder flexion, abduction, and external ROM were
        statistically analyzed and compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients were subdivided into two groups, fifteen patients in each group. Group A received the muscle energy technique and group B received Maitland's mobilization.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Visual analogue scale (VAS)
  time frame: Change from baseline at four weeks after the intervention
  description: A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiology and clinical research to measure the intensity or frequency of various symptoms.
  measure: The SPADI (Shoulder Pain and Disability Index)
  time frame: Change from baseline at four weeks after the intervention
  description: It is a self-reported questionnaire consisting of 13 items divided in two parts: pain and disability sub-scale.
  measure: Shoulder active range of motion
  time frame: Change from baseline at four weeks after the intervention
  description: Through using the universal goniometer to measure the shoulder flexion, abduction and, external rotation.
  arm group label: Muscle energy technique
  arm group type: Active Comparator
  description: This group includes 15 patients who received muscle energy technique post-surgery in addition to traditional shoulder exercise, 3 sessions/week for four weeks.
  arm group label: Maitland mobilization
  arm group type: Active Comparator
  description: This group includes 15 patients who received mobilization in addition to traditional shoulder exercise, 3 sessions/week for four weeks.
  intervention type: Other
  intervention name: Muscle energy technique
  description: It was applied on the shoulder flexion and the external rotation. An isometric contraction of the agonist muscle (the muscle which requires stretching) for 7 seconds with gentle muscle contraction to avoid the risk of increasing the muscle tone. This contraction started just short of the restrictive barrier. After that, the patient is asked to relax for 2-3 seconds and then the therapist stretches the contracted muscle in the opposite direction for 30 seconds. This is repeated three repetitions for each muscle.
  arm group label: Muscle energy technique
  intervention type: Other
  intervention name: Maitland mobilization
  description: At the start of each session, the physical therapist examined the patient's ROM in all directions to obtain information about the end-range position and the end feel of the glenohumeral joint. Start with rhythmic mid-range mobilization with the patient in a supine position. The therapist's hands are placed close to the glenohumeral joint, and the humerus is brought into a position of maximal flexion in the sagittal plane. After 10 to 15 repetitions of intensive mobilization techniques in this end-range position, the direction of mobilization will be altered by varying the plane of elevation or by varying the degree of rotation. When alternating the direction of mobilization, other movements such as gliding techniques and distraction in that joint position were (inferior gliding, anterior gliding, and posterior gliding).
  arm group label: Maitland mobilization
  intervention type: Other
  intervention name: Traditional shoulder exercise
  description: Traditional shoulder exercises in the form of shoulder range of motion exercises, stretching exercises and, scapular stabilization.
  arm group label: Maitland mobilization
  arm group label: Muscle energy technique
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Shaimaa MA El Sayeh, PhD
  role: Study Director
  affiliation: Lecturer at Faculty of Physical Therapy, Cairo University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Shaimaa Mohamed Ahmed Elsayeh
  investigator title: Lecturer of Physical Therapy
  mesh term: Shoulder Pain
  mesh term: Mobility Limitation
  sharing ipd: No