<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/NCT02198040</url>
  </required_header>
  <id_info>
    <org_study_id>ELBOW</org_study_id>
    <secondary_id>ELBOW</secondary_id>
    <nct_id>NCT02198040</nct_id>
  </id_info>
  <brief_title>Physiotherapy in the Haemophilic Arthropathy of the Elbow.</brief_title>
  <acronym>ELBOW</acronym>
  <official_title>Physiotherapy in the Treatment of Elbow Hemophilic Arthropathy: Manual Therapy vs Educational Physiotherapy. A Pilot Sudy</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>
      The aim of this study is to assess the effectiveness of two treatments of Physiotherapy: one&#xD;
      with joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation&#xD;
      (PNF), and the other with education sessions and home exercises, for the improvement of the&#xD;
      ROM, biceps strength, perimeter of arm and the perception of pain in PwH and arthropathy of&#xD;
      the elbow.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention was carried out during twelve weeks, performing evaluations before and after&#xD;
      treatment, and six months of finalizing this. The treatment of MT group consisted of two&#xD;
      sessions per week, one hour each, and the treatment of group E consisted in a session for 90&#xD;
      minutes every two weeks, with daily home exercises. The control group (group C) did not&#xD;
      receive any intervention.&#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 Range of Motion of Elbow</measure>
    <time_frame>Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)</time_frame>
    <description>Measurement the changes of flexion and extension of elbow (in degrees) using a universal goniometer. We were taken as anatomical references, those specified by Querol et al, using the zero-method-reference for the mobile arm goniometer as indicated Norkin et al.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the Circumference of Arm</measure>
    <time_frame>Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)</time_frame>
    <description>Measurement of the arm circumference (in cm) at baseline as a result of hemophilic arthropathy and after treatment and follow-up. The measurement in the upper third of the arm, in the middle of the triceps muscle belly, with a tape measure. We use this outcome to measure circumference of the arm, it is the most clinical measurement used by physiotherapists.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Biceps Strength</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 breaking test for patients with haemophilia with a score from 0 to 5 (where 0 indicates normal strength and 5 is the absence of muscle contraction).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the Pain Perception of Elbow</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 analogue scale, VAS (subjective rating scale with a score from 0 to 10, where 0 indicates no pain and 10 the maximum pain imaginable by the patient).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Radiological Joint Deterioration</measure>
    <time_frame>Screening visit (pretreatment assessment)</time_frame>
    <description>Pettersson scale is an additive scale that assesses the radiological joint damage in patients with hemophilic arthropathy. It is scored as a range of 0-13 points (0: no joint damage; 13: maximum joint damage). This scale assesses: osteoporosis, widened epiphyseal, irregularity of the chondral surface, joint space narrowing, subchondral cyst formation, joint margins erosion, joint incongruence and joint deformity (angulation and displacement)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characteristics of the Patients</measure>
    <time_frame>Screening visit (pretreatment assessment)</time_frame>
    <description>Age of patients included in teh study (years)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Elbow Hemarthrosis</measure>
    <time_frame>Screening visit (pretreatment assessment)</time_frame>
    <description>Number of elbow hemarthrosis in the month prior to study</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Patients With Hemophilia</condition>
  <arm_group>
    <arm_group_label>Manual Therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.</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 did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Therapy</intervention_name>
    <description>5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.&#xD;
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.&#xD;
15 minutes. Passive muscle stretching (within the limits of mobility).&#xD;
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder.&#xD;
10 minutes. Local cryotherapy with ice bag and protection between it and the skin</description>
    <arm_group_label>Manual Therapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational group</intervention_name>
    <description>Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.&#xD;
Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.</description>
    <arm_group_label>Educational group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years&#xD;
&#xD;
          -  Patients diagnosed with hemophilia A or B&#xD;
&#xD;
          -  Patients with hemophilic arthropathy in one or both elbows&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with another medical diagnosis (eg, Von Willebrand's disease)&#xD;
&#xD;
          -  Patients with presence of antibodies to FVIII or FIX (inhibitors)&#xD;
&#xD;
          -  Patients who had a haemarthrosis of elbow during the study&#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>December 2016</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>
  <results_first_submitted>October 7, 2015</results_first_submitted>
  <results_first_submitted_qc>December 30, 2016</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2017</results_first_posted>
  <last_update_submitted>January 31, 2018</last_update_submitted>
  <last_update_submitted_qc>January 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2018</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, PhD</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Elbow</keyword>
  <keyword>Joint disease</keyword>
  <keyword>Hemophilia</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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>27 patients Hemophilia of the Association of Murcia were recruited between January to October 2013</recruitment_details>
      <pre_assignment_details>28 patients who met the exclusion criteria. Only one declined to participate for personal reasons.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Manual Therapy Group</title>
          <description>The treatment of this group consisted of two sessions per week, one hour each. Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.&#xD;
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.&#xD;
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.&#xD;
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist, to adduction, internal rotation of shoulder with flexion of elbow and palmar flexion of wrist and fingers.&#xD;
10</description>
        </group>
        <group group_id="P2">
          <title>Educational Gruop</title>
          <description>The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.&#xD;
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.&#xD;
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.</description>
        </group>
        <group group_id="P3">
          <title>Control Group</title>
          <description>The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Work reasons</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Manual Therapy Group</title>
          <description>The treatment of this group consisted of two sessions per week, one hour each.&#xD;
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.&#xD;
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.&#xD;
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.&#xD;
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist, to adduction, internal rotation of shoulder with flexion of elbow and palmar flexion of wrist and fingers.&#xD;
10 minutes. Local cryotherapy with ice bag and protection between it and the skin</description>
        </group>
        <group group_id="B2">
          <title>Educational Gruop</title>
          <description>The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.&#xD;
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.&#xD;
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.</description>
        </group>
        <group group_id="B3">
          <title>Control Group</title>
          <description>The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="9"/>
            <count group_id="B4" value="27"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Radiological joint deterioration</title>
          <description>Radiological joint deterioration of elbows with Pettersson score. Mean score (and standard deviation) for elbow joint evaluated in patients enrolled in the study. This scale has a range from 0 to 13 points (0 indicates no joint damage and 13 indicates maximum joint damage) to assess the hemophilic arthropathy.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.63" spread="1.62"/>
                    <measurement group_id="B2" value="8.50" spread="3.40"/>
                    <measurement group_id="B3" value="7.57" spread="2.90"/>
                    <measurement group_id="B4" value="8.61" spread="2.809"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in Range of Motion of Elbow</title>
        <description>Measurement the changes of flexion and extension of elbow (in degrees) using a universal goniometer. We were taken as anatomical references, those specified by Querol et al, using the zero-method-reference for the mobile arm goniometer as indicated Norkin et al.</description>
        <time_frame>Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)</time_frame>
        <population>It has made an analysis by intention to treat with the 27 patients included in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Educational Gruop</title>
            <description>The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.&#xD;
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.&#xD;
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.</description>
          </group>
          <group group_id="O2">
            <title>Manual Therapy Group</title>
            <description>The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation&#xD;
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.&#xD;
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.&#xD;
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.&#xD;
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.&#xD;
10 minutes. Local cryotherapy with ice bag and protection between it and the skin</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Range of Motion of Elbow</title>
          <description>Measurement the changes of flexion and extension of elbow (in degrees) using a universal goniometer. We were taken as anatomical references, those specified by Querol et al, using the zero-method-reference for the mobile arm goniometer as indicated Norkin et al.</description>
          <population>It has made an analysis by intention to treat with the 27 patients included in the study.</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pretreatment assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138.31" spread="16.103"/>
                    <measurement group_id="O2" value="136.13" spread="14.818"/>
                    <measurement group_id="O3" value="138.00" spread="19.958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postreatment assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135.56" spread="16.66"/>
                    <measurement group_id="O2" value="140.31" spread="11.24"/>
                    <measurement group_id="O3" value="138.43" spread="18.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow up assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139.19" spread="16.64"/>
                    <measurement group_id="O2" value="140.31" spread="14.44"/>
                    <measurement group_id="O3" value="138.07" spread="17.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in the Circumference of Arm</title>
        <description>Measurement of the arm circumference (in cm) at baseline as a result of hemophilic arthropathy and after treatment and follow-up. The measurement in the upper third of the arm, in the middle of the triceps muscle belly, with a tape measure. We use this outcome to measure circumference of the arm, it is the most clinical measurement used by physiotherapists.</description>
        <time_frame>Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)</time_frame>
        <population>It has made an analysis by intention to treat with the 27 patients included in the study</population>
        <group_list>
          <group group_id="O1">
            <title>Educational Gruop</title>
            <description>The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.&#xD;
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.&#xD;
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.</description>
          </group>
          <group group_id="O2">
            <title>Manual Therapy Group</title>
            <description>The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation&#xD;
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.&#xD;
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.&#xD;
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.&#xD;
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.&#xD;
10 minutes. Local cryotherapy with ice bag and protection between it and the skin</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Circumference of Arm</title>
          <description>Measurement of the arm circumference (in cm) at baseline as a result of hemophilic arthropathy and after treatment and follow-up. The measurement in the upper third of the arm, in the middle of the triceps muscle belly, with a tape measure. We use this outcome to measure circumference of the arm, it is the most clinical measurement used by physiotherapists.</description>
          <population>It has made an analysis by intention to treat with the 27 patients included in the study</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pretreatment assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.125" spread="3.144"/>
                    <measurement group_id="O2" value="31.331" spread="3.474"/>
                    <measurement group_id="O3" value="32.007" spread="3.837"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postreatment assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.23" spread="3.22"/>
                    <measurement group_id="O2" value="31.72" spread="3.20"/>
                    <measurement group_id="O3" value="31.85" spread="3.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow up assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.02" spread="3.13"/>
                    <measurement group_id="O2" value="30.96" spread="2.70"/>
                    <measurement group_id="O3" value="31.68" spread="4.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Biceps Strength</title>
        <description>Measured by the breaking test for patients with haemophilia with a score from 0 to 5 (where 0 indicates normal strength and 5 is the absence of muscle contraction).</description>
        <time_frame>Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)</time_frame>
        <population>It has made an analysis by intention to treat with the 27 patients included in the study</population>
        <group_list>
          <group group_id="O1">
            <title>Educational Gruop</title>
            <description>The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.&#xD;
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.&#xD;
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.</description>
          </group>
          <group group_id="O2">
            <title>Manual Therapy Group</title>
            <description>The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation&#xD;
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.&#xD;
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.&#xD;
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.&#xD;
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.&#xD;
10 minutes. Local cryotherapy with ice bag and protection between it and the skin</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Biceps Strength</title>
          <description>Measured by the breaking test for patients with haemophilia with a score from 0 to 5 (where 0 indicates normal strength and 5 is the absence of muscle contraction).</description>
          <population>It has made an analysis by intention to treat with the 27 patients included in the study</population>
          <units>points</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pretreatment assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="0.000"/>
                    <measurement group_id="O2" value="0.094" spread="0.272"/>
                    <measurement group_id="O3" value="0.143" spread="0.363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postreatment assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.12"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="0.07" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow up assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.17"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="0.07" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in the Pain Perception of Elbow</title>
        <description>Using the visual analogue scale, VAS (subjective rating scale with a score from 0 to 10, where 0 indicates no pain and 10 the maximum pain imaginable by the patient).</description>
        <time_frame>Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Educational Gruop</title>
            <description>The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.&#xD;
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.&#xD;
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.</description>
          </group>
          <group group_id="O2">
            <title>Manual Therapy Group</title>
            <description>The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation&#xD;
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.&#xD;
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.&#xD;
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.&#xD;
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.&#xD;
10 minutes. Local cryotherapy with ice bag and protection between it and the skin</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Pain Perception of Elbow</title>
          <description>Using the visual analogue scale, VAS (subjective rating scale with a score from 0 to 10, where 0 indicates no pain and 10 the maximum pain imaginable by the patient).</description>
          <units>points</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pretreatment assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.156" spread="0.301"/>
                    <measurement group_id="O2" value="0.719" spread="0.752"/>
                    <measurement group_id="O3" value="0.143" spread="0.305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postreatment assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="0.20"/>
                    <measurement group_id="O2" value="0.34" spread="0.43"/>
                    <measurement group_id="O3" value="0.07" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow up assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.35"/>
                    <measurement group_id="O2" value="0.12" spread="0.28"/>
                    <measurement group_id="O3" value="0.10" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Radiological Joint Deterioration</title>
        <description>Pettersson scale is an additive scale that assesses the radiological joint damage in patients with hemophilic arthropathy. It is scored as a range of 0-13 points (0: no joint damage; 13: maximum joint damage). This scale assesses: osteoporosis, widened epiphyseal, irregularity of the chondral surface, joint space narrowing, subchondral cyst formation, joint margins erosion, joint incongruence and joint deformity (angulation and displacement)</description>
        <time_frame>Screening visit (pretreatment assessment)</time_frame>
        <population>It has made an analysis by intention to treat with the 27 patients included in the study. It has been estimated the radiological joint damage means (and standard deviation) for elbow joint.</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Therapy Group</title>
            <description>The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation&#xD;
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.&#xD;
15 minutes. Joint traction of elbow. Joint traction in I-II degree of flexion and extension submaximal of elbow.&#xD;
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.&#xD;
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist.&#xD;
10</description>
          </group>
          <group group_id="O2">
            <title>Educational Gruop</title>
            <description>The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.&#xD;
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.&#xD;
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Radiological Joint Deterioration</title>
          <description>Pettersson scale is an additive scale that assesses the radiological joint damage in patients with hemophilic arthropathy. It is scored as a range of 0-13 points (0: no joint damage; 13: maximum joint damage). This scale assesses: osteoporosis, widened epiphyseal, irregularity of the chondral surface, joint space narrowing, subchondral cyst formation, joint margins erosion, joint incongruence and joint deformity (angulation and displacement)</description>
          <population>It has made an analysis by intention to treat with the 27 patients included in the study. It has been estimated the radiological joint damage means (and standard deviation) for elbow joint.</population>
          <units>points</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.63" spread="1.62"/>
                    <measurement group_id="O2" value="8.50" spread="3.40"/>
                    <measurement group_id="O3" value="7.57" spread="2.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Characteristics of the Patients</title>
        <description>Age of patients included in teh study (years)</description>
        <time_frame>Screening visit (pretreatment assessment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Educational Gruop</title>
            <description>The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.&#xD;
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.&#xD;
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.</description>
          </group>
          <group group_id="O2">
            <title>Manual Therapy Group</title>
            <description>The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation&#xD;
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.&#xD;
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.&#xD;
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.&#xD;
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.&#xD;
10 minutes. Local cryotherapy with ice bag and protection between it and the skin</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Characteristics of the Patients</title>
          <description>Age of patients included in teh study (years)</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.78" spread="15.72"/>
                    <measurement group_id="O2" value="32.33" spread="11.67"/>
                    <measurement group_id="O3" value="37.33" spread="12.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Elbow Hemarthrosis</title>
        <description>Number of elbow hemarthrosis in the month prior to study</description>
        <time_frame>Screening visit (pretreatment assessment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Educational Gruop</title>
            <description>The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.&#xD;
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.&#xD;
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.</description>
          </group>
          <group group_id="O2">
            <title>Manual Therapy Group</title>
            <description>The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation&#xD;
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.&#xD;
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.&#xD;
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.&#xD;
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.&#xD;
10 minutes. Local cryotherapy with ice bag and protection between it and the skin</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Elbow Hemarthrosis</title>
          <description>Number of elbow hemarthrosis in the month prior to study</description>
          <units>bleeding events</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemarthros the month before the beginning of the s</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.06" spread="1.23"/>
                    <measurement group_id="O2" value="1.06" spread="0.68"/>
                    <measurement group_id="O3" value="0.71" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemarthros during the study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="0.62" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Educational Gruop</title>
          <description>The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.&#xD;
Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.&#xD;
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.</description>
        </group>
        <group group_id="E2">
          <title>Manual Therapy Group</title>
          <description>The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation&#xD;
Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.&#xD;
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.&#xD;
15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.&#xD;
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.&#xD;
10 minutes. Local cryotherapy with ice bag and protection between it and the skin</description>
        </group>
        <group group_id="E3">
          <title>Control Group</title>
          <description>The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>A limitation of our study is the low sample size (n = 27), although 96% of paients who met the inclusion criteria participated Due to the randomization of subjects there was no division proportionate according to the severity of haemophilia</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Rubén Cuesta-Barriuso, PhD</name_or_title>
      <organization>Universidad de Murcia</organization>
      <phone>+34 913146508</phone>
      <email>ruben.cuestab@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02198040
org study id: ELBOW
secondary id: ELBOW
nct id: NCT02198040
lead sponsor: 
has dmc: No
The aim of this study is to assess the effectiveness of two treatments of Physiotherapy: one
      with joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation
      (PNF), and the other with education sessions and home exercises, for the improvement of the
      ROM, biceps strength, perimeter of arm and the perception of pain in PwH and arthropathy of
      the elbow.
The intervention was carried out during twelve weeks, performing evaluations before and after
      treatment, and six months of finalizing this. The treatment of MT group consisted of two
      sessions per week, one hour each, and the treatment of group E consisted in a session for 90
      minutes every two weeks, with daily home exercises. The control group (group C) did not
      receive any intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in Range of Motion of Elbow
time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
description: Measurement the changes of flexion and extension of elbow (in degrees) using a universal goniometer. We were taken as anatomical references, those specified by Querol et al, using the zero-method-reference for the mobile arm goniometer as indicated Norkin et al.
measure: Changes in the Circumference of Arm
time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
description: Measurement of the arm circumference (in cm) at baseline as a result of hemophilic arthropathy and after treatment and follow-up. The measurement in the upper third of the arm, in the middle of the triceps muscle belly, with a tape measure. We use this outcome to measure circumference of the arm, it is the most clinical measurement used by physiotherapists.
measure: Changes in Biceps Strength
time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
description: Measured by the breaking test for patients with haemophilia with a score from 0 to 5 (where 0 indicates normal strength and 5 is the absence of muscle contraction).
measure: Changes in the Pain Perception of Elbow
time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
description: Using the visual analogue scale, VAS (subjective rating scale with a score from 0 to 10, where 0 indicates no pain and 10 the maximum pain imaginable by the patient).
measure: Assessment of Radiological Joint Deterioration
time frame: Screening visit (pretreatment assessment)
description: Pettersson scale is an additive scale that assesses the radiological joint damage in patients with hemophilic arthropathy. It is scored as a range of 0-13 points (0: no joint damage; 13: maximum joint damage). This scale assesses: osteoporosis, widened epiphyseal, irregularity of the chondral surface, joint space narrowing, subchondral cyst formation, joint margins erosion, joint incongruence and joint deformity (angulation and displacement)
measure: Characteristics of the Patients
time frame: Screening visit (pretreatment assessment)
description: Age of patients included in teh study (years)
measure: Frequency of Elbow Hemarthrosis
time frame: Screening visit (pretreatment assessment)
description: Number of elbow hemarthrosis in the month prior to study
arm group label: Manual Therapy group
arm group type: Experimental
description: The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation
arm group label: Educational group
arm group type: Experimental
description: The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.
arm group label: Control group
arm group type: No Intervention
description: The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
intervention type: Other
intervention name: Manual Therapy
description: 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
15 minutes. Passive muscle stretching (within the limits of mobility).
15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder.
10 minutes. Local cryotherapy with ice bag and protection between it and the skin
arm group label: Manual Therapy group
intervention type: Other
intervention name: Educational group
description: Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.
arm group label: Educational group
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, PhD
investigator title: PhD
mesh term: Joint Diseases
mesh term: Hemophilia A
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: A limitation of our study is the low sample size (n = 27), although 96% of paients who met the inclusion criteria participated Due to the randomization of subjects there was no division proportionate according to the severity of haemophilia
point of contact: 