<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/NCT02198014</url>
  </required_header>
  <id_info>
    <org_study_id>ARTHROPATHY</org_study_id>
    <secondary_id>ARTHROPAT</secondary_id>
    <nct_id>NCT02198014</nct_id>
  </id_info>
  <brief_title>Manual Therapy in Haemophilic Arthropathy of the Knee</brief_title>
  <acronym>ARTHROPA</acronym>
  <official_title>Effectiveness of Manual Therapy and Educational Physiotherapy in the Treatment of Hemophilic Arthropathy of the Knee. A Randomized Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess the effectiveness of two Physiotherapy treatments: one with manual&#xD;
      therapy using joint traction, passive muscle stretching, and isometric exercise, active&#xD;
      resisted and proprioception exercises; and other treatment with educational sessions and home&#xD;
      exercises to improve the ROM, muscle strength and proprioception in patients with haemophilia&#xD;
      and arthropathy of the knee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized trial with two treatment groups: one using joint traction, passive muscle&#xD;
      stretching and isometric exercises, active resisted and proprioception exercises (group MT);&#xD;
      and another with educational sessions and home exercises (group E); and a control group&#xD;
      (group C).&#xD;
&#xD;
      The intervention was carried out during twelve weeks, performing evaluation before and after&#xD;
      treatment, and six months of finalizing this. The treatment in MT group consisted of two&#xD;
      sessions per week for one hour each, and the treatment in group E consisted of a session of&#xD;
      90 minute every two weeks, with exercises daily home. The control group (group C) did not&#xD;
      receive any treatment. After the allocation to the groups, the composition was follows: MT&#xD;
      group = 7; E group = 7; and control group = 7.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Changes in the range of movement (ROM)</measure>
    <time_frame>Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)</time_frame>
    <description>Measurement of knee flexion and extension using a universal goniometer. Were taken as anatomical references, are indicated by Querol et al, using the reference method 0 to the mobile arm of the goniometer, as noted Norkin et al.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in quadriceps muscle circumference</measure>
    <time_frame>Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)</time_frame>
    <description>Measurement in the thigh, in two thirds of the flow distance between the anterior superior iliac spine and the joint line of the knee, using a tape measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in muscle strength of quadriceps</measure>
    <time_frame>Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)</time_frame>
    <description>Measured by the rupture test for hemophilia patients (with a gradation of 0 to 5 points, with 0 indicating normal strength and 5 is the absence of muscle contraction).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the perception of pain</measure>
    <time_frame>Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)</time_frame>
    <description>Using the visual analog scale, VAS, consisting of a gradation of 0 to 10 points (from no pain to worst pain imaginable).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the assessment of radiological joint deterioration</measure>
    <time_frame>Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)</time_frame>
    <description>We use the Petterson scale which consists of 13 items (0 indicates a normal joint and joint deterioration 13 maximum).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjects' physical characteristics</measure>
    <time_frame>Screening visit (pretreatment assessment)</time_frame>
    <description>Age of patient (years), Weight of patient (kg), Number of ankle haemarthrosis in previous year, Type of haemophilia (A or B), Severity of haemophilia (severe or moderate), Treatment (prophylaxis or on demand).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the frequency of knee hemarthrosis</measure>
    <time_frame>Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)</time_frame>
    <description>Evaluation of knee bleeding before, during and after physiotherapy treatment. Hemarthrosis must be diagnosed clinically.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Patients With Haemophilia</condition>
  <arm_group>
    <arm_group_label>Manual Therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We employed joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises. The treatment in this group consisted of two sessions per week for one hour each.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational gruop</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group received educational sessions and home exercises. The exercises are aimed at improving quadriceps strength, flexibility, range of motion and knee proprioception.&#xD;
Each educational session of 90 minute every two weeks, with exercises daily home</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group (group C) did not receive any treatment. The patients of this group were assessed by the same reviewers and under the same conditions as the subjects of the two intervention groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Therapy</intervention_name>
    <description>5 minutes. Thermotherapy shallow to 50 cm away from the knee. 15 minutes. Joint traction, grade I-II. Fixation of distal femur with cinch and manual fixation of proximal tibia. Patient in prone position and the traction is carried out in the submaximal ranges of flexion and extension.&#xD;
10 minutes. Passive muscle stretching of quadriceps (within the limits of mobility), through compression muscle, passive muscle stretching and relaxation of muscle.&#xD;
10 minutes. Isometric and resisted exercises of quadriceps, in submaximal ranges, of flexion and extension.&#xD;
10 minutes. Proprioception exercises with unipodal support, with and without visual support, and posterior destabilization.&#xD;
10 minutes. Local cryotherapy with ice pack.</description>
    <arm_group_label>Manual Therapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Physiotherapy</intervention_name>
    <description>Theory. Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of knee; Anatomy of ankle musculature; Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.&#xD;
Practice: exercises in favor of gravity; active exercises for mobility and pain management; knee proprioception exercises; isometric and isotonic exercises of quadriceps; swimming and cycling technique.</description>
    <arm_group_label>Educational gruop</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be over the age of 18 years&#xD;
&#xD;
          -  Diagnosis of haemophilia A or B&#xD;
&#xD;
          -  Patients with haemophilic arthropathy in one or both knees&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had a haemarthrosis of knee during intervention&#xD;
&#xD;
          -  Patients with different medical diagnosis (eg, Von Willebrand's disease)&#xD;
&#xD;
          -  Patients with antibodies to FVIII or FIX (inhibitors).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>RUBEN CUESTA-BARRIUSO, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Católica San Antonio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad de Murcia</name>
      <address>
        <city>Murcia</city>
        <zip>30100</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 22, 2014</last_update_submitted>
  <last_update_submitted_qc>July 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>RUBÉN CUESTA-BARRIUSO</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Knee</keyword>
  <keyword>Joint disease</keyword>
  <keyword>Haemophilia</keyword>
  <keyword>Physiotherapy modalities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Hemophilia A</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 7, 2015</submitted>
    <returned>November 13, 2015</returned>
    <submitted>June 29, 2016</submitted>
    <returned>August 12, 2016</returned>
    <submitted>August 26, 2016</submitted>
    <returned>October 18, 2016</returned>
  </pending_results>
  <!-- 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/NCT02198014
org study id: ARTHROPATHY
secondary id: ARTHROPAT
nct id: NCT02198014
lead sponsor: 
has dmc: No
This study aims to assess the effectiveness of two Physiotherapy treatments: one with manual
      therapy using joint traction, passive muscle stretching, and isometric exercise, active
      resisted and proprioception exercises; and other treatment with educational sessions and home
      exercises to improve the ROM, muscle strength and proprioception in patients with haemophilia
      and arthropathy of the knee.
Randomized trial with two treatment groups: one using joint traction, passive muscle
      stretching and isometric exercises, active resisted and proprioception exercises (group MT);
      and another with educational sessions and home exercises (group E); and a control group
      (group C).

      The intervention was carried out during twelve weeks, performing evaluation before and after
      treatment, and six months of finalizing this. The treatment in MT group consisted of two
      sessions per week for one hour each, and the treatment in group E consisted of a session of
      90 minute every two weeks, with exercises daily home. The control group (group C) did not
      receive any treatment. After the allocation to the groups, the composition was follows: MT
      group = 7; E group = 7; and control group = 7.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in the range of movement (ROM)
time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
description: Measurement of knee flexion and extension using a universal goniometer. Were taken as anatomical references, are indicated by Querol et al, using the reference method 0 to the mobile arm of the goniometer, as noted Norkin et al.
measure: Changes in quadriceps muscle circumference
time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
description: Measurement in the thigh, in two thirds of the flow distance between the anterior superior iliac spine and the joint line of the knee, using a tape measure
measure: Changes in muscle strength of quadriceps
time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
description: Measured by the rupture test for hemophilia patients (with a gradation of 0 to 5 points, with 0 indicating normal strength and 5 is the absence of muscle contraction).
measure: Changes in the perception of pain
time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
description: Using the visual analog scale, VAS, consisting of a gradation of 0 to 10 points (from no pain to worst pain imaginable).
measure: Changes in the assessment of radiological joint deterioration
time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
description: We use the Petterson scale which consists of 13 items (0 indicates a normal joint and joint deterioration 13 maximum).
measure: Subjects' physical characteristics
time frame: Screening visit (pretreatment assessment)
description: Age of patient (years), Weight of patient (kg), Number of ankle haemarthrosis in previous year, Type of haemophilia (A or B), Severity of haemophilia (severe or moderate), Treatment (prophylaxis or on demand).
measure: Changes in the frequency of knee hemarthrosis
time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
description: Evaluation of knee bleeding before, during and after physiotherapy treatment. Hemarthrosis must be diagnosed clinically.
arm group label: Manual Therapy group
arm group type: Experimental
description: We employed joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises. The treatment in this group consisted of two sessions per week for one hour each.
arm group label: Educational gruop
arm group type: Experimental
description: This group received educational sessions and home exercises. The exercises are aimed at improving quadriceps strength, flexibility, range of motion and knee proprioception.
Each educational session of 90 minute every two weeks, with exercises daily home
arm group label: Control group
arm group type: No Intervention
description: The control group (group C) did not receive any treatment. The patients of this group were assessed by the same reviewers and under the same conditions as the subjects of the two intervention groups.
intervention type: Other
intervention name: Manual Therapy
description: 5 minutes. Thermotherapy shallow to 50 cm away from the knee. 15 minutes. Joint traction, grade I-II. Fixation of distal femur with cinch and manual fixation of proximal tibia. Patient in prone position and the traction is carried out in the submaximal ranges of flexion and extension.
10 minutes. Passive muscle stretching of quadriceps (within the limits of mobility), through compression muscle, passive muscle stretching and relaxation of muscle.
10 minutes. Isometric and resisted exercises of quadriceps, in submaximal ranges, of flexion and extension.
10 minutes. Proprioception exercises with unipodal support, with and without visual support, and posterior destabilization.
10 minutes. Local cryotherapy with ice pack.
arm group label: Manual Therapy group
intervention type: Other
intervention name: Educational Physiotherapy
description: Theory. Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of knee; Anatomy of ankle musculature; Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
Practice: exercises in favor of gravity; active exercises for mobility and pain management; knee proprioception exercises; isometric and isotonic exercises of quadriceps; swimming and cycling technique.
arm group label: Educational gruop
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: RUBEN CUESTA-BARRIUSO, PhD
role: Principal Investigator
affiliation: Universidad Católica San Antonio
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: RUBÉN CUESTA-BARRIUSO
investigator title: PhD
mesh term: Joint Diseases
mesh term: Hemophilia A
submitted: October 7, 2015
returned: November 13, 2015
submitted: June 29, 2016
returned: August 12, 2016
submitted: August 26, 2016
returned: October 18, 2016