<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/NCT03771495</url>
  </required_header>
  <id_info>
    <org_study_id>G Pflügler 09-18</org_study_id>
    <nct_id>NCT03771495</nct_id>
  </id_info>
  <brief_title>The Immediate Effects of Passive Hip Joint Mobilization on Hip Muscle Strength in Patients With Anterior Knee Pain</brief_title>
  <official_title>What Are the Immediate Effects of Passive Hip Joint Mobilization on Hip Abductor/External Rotator Muscle Strength in Patients With Anterior Knee Pain and Impaired Hip Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Hallam University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheffield Hallam University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to assess the immediate effects of passive hip joint mobilisation (in&#xD;
      comparison to a sham mobilisation) on eccentric hip abductor/external rotator muscle strength&#xD;
      on the basis of manual muscle testing with a hand-held-dynamometer within a double-blinded&#xD;
      cross-over study design. Patients with anterior knee pain and signs of impaired hip function&#xD;
      will be recruited in Vienna and surrounding area, measurements/data collection will be&#xD;
      conducted by two experienced physiotherapists in a physiotherapy group practice in 1150&#xD;
      Vienna.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2018</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>10 minutes</time_frame>
    <description>muscle strength data obtained from torque measurements of the hip abductor/external rotator muscles of participants before and after intervention via manual muscle testing (using a hand-held dynamometer)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Anterior Knee Pain Syndrome</condition>
  <condition>Patellofemoral Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Hip Joint Mobilization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>passive accessory movement on femur in anterior/posterior direction, grade III for four minutes and passive physiological movement of the most restricted hip joint movement, grade III for one minute (without pain), and a verbal education of hypothesized underlying effect mechanisms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laying on of Hands</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>grade I, very small amplitude without encountering any tissue resistance for five minutes, thus effectively a Laying on of Hands, with a verbal education of hypothesized underlying effect mechanisms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Joint Mobilization</intervention_name>
    <description>Manual Therapy Intervention, commonly used by physiotherapists</description>
    <arm_group_label>Hip Joint Mobilization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laying on of Hands</intervention_name>
    <description>Sham Hip Joint Mobilization</description>
    <arm_group_label>Laying on of Hands</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis: anterior knee pain&#xD;
&#xD;
          -  Prescription for physiotherapeutic treatment of anterior knee pain&#xD;
&#xD;
          -  signs of functional hip impairment:&#xD;
&#xD;
          -  impaired hip kinematics during single leg squat&#xD;
&#xD;
          -  reduced passive hip joint mobility in comparison to the other, unaffected side&#xD;
&#xD;
          -  manually weak tested hip abductors/external rota-tors in comparison to the other,&#xD;
             unaffected side&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intraarticular knee pathology&#xD;
&#xD;
          -  preceding trauma/operation of lower extremity on affected side&#xD;
&#xD;
          -  spinal disorders associated with low back pain, lumbar referred pain or nerve root&#xD;
             irritation&#xD;
&#xD;
          -  severe and/or recurring ankle sprains in recent history (significant enough, that it&#xD;
             required a period of immobilization)&#xD;
&#xD;
          -  other relevant comorbidities such as neurologic/rheumatologic/psychiatric diseases,&#xD;
             osteoporosis and malign disorders&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sionnadh McLean</last_name>
    <role>Study Director</role>
    <affiliation>Sheffield Hallam University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Praxisgemeinschaft &quot;Bewegungsoase&quot;</name>
      <address>
        <city>Vienna</city>
        <zip>1150</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>June 5, 2019</last_update_submitted>
  <last_update_submitted_qc>June 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mobilization</keyword>
  <keyword>muscle strength</keyword>
  <keyword>hip abductors</keyword>
  <keyword>hip external rotators</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Somatoform Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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>December 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03771495/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/NCT03771495
org study id: G Pflügler 09-18
nct id: NCT03771495
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to assess the immediate effects of passive hip joint mobilisation (in
      comparison to a sham mobilisation) on eccentric hip abductor/external rotator muscle strength
      on the basis of manual muscle testing with a hand-held-dynamometer within a double-blinded
      cross-over study design. Patients with anterior knee pain and signs of impaired hip function
      will be recruited in Vienna and surrounding area, measurements/data collection will be
      conducted by two experienced physiotherapists in a physiotherapy group practice in 1150
      Vienna.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Muscle Strength
time frame: 10 minutes
description: muscle strength data obtained from torque measurements of the hip abductor/external rotator muscles of participants before and after intervention via manual muscle testing (using a hand-held dynamometer)
arm group label: Hip Joint Mobilization
arm group type: Experimental
description: passive accessory movement on femur in anterior/posterior direction, grade III for four minutes and passive physiological movement of the most restricted hip joint movement, grade III for one minute (without pain), and a verbal education of hypothesized underlying effect mechanisms.
arm group label: Laying on of Hands
arm group type: Sham Comparator
description: grade I, very small amplitude without encountering any tissue resistance for five minutes, thus effectively a Laying on of Hands, with a verbal education of hypothesized underlying effect mechanisms.
intervention type: Other
intervention name: Joint Mobilization
description: Manual Therapy Intervention, commonly used by physiotherapists
arm group label: Hip Joint Mobilization
intervention type: Other
intervention name: Laying on of Hands
description: Sham Hip Joint Mobilization
arm group label: Laying on of Hands
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sionnadh McLean
role: Study Director
affiliation: Sheffield Hallam University
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Patellofemoral Pain Syndrome
mesh term: Syndrome
mesh term: Somatoform Disorders
sharing ipd: Undecided
provided document: 