<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/NCT03009591</url>
  </required_header>
  <id_info>
    <org_study_id>HeL-Fascial</org_study_id>
    <nct_id>NCT03009591</nct_id>
  </id_info>
  <brief_title>Fascial Therapy in Elbow Hemophilic Arthropathy</brief_title>
  <acronym>HeL-Fascial</acronym>
  <official_title>Prospective and Multicenter Study to Assess the Safety and Effectiveness of a Physiotherapy Treatment Through Fascial Therapy in Hemophilic Elbow Arthropathy. A Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Real Fundación Victoria Eugenia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Real Fundación Victoria Eugenia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds,&#xD;
      especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints,&#xD;
      causing a progressive joint deterioration. Secondary disorders to this joint degeneration&#xD;
      include: biomechanical alterations, loss of range of movement and periarticular muscle&#xD;
      atrophy.&#xD;
&#xD;
      Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of a&#xD;
      treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of&#xD;
      the elbow.&#xD;
&#xD;
      Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy in&#xD;
      patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with&#xD;
      hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients&#xD;
      will be recruited in 6 centers, from different regions of Spain.&#xD;
&#xD;
      Intervention: Each session will last approximately 50 minutes, with three physiotherapy&#xD;
      sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers&#xD;
      that must be administered bilaterally:&#xD;
&#xD;
      Measuring instruments and study variables: goniometric evaluation (range of movement); visual&#xD;
      analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH Questionnaire&#xD;
      (functionality of upper limbs); SF-36 Questionnaire (perception of quality of life). At the&#xD;
      same time, the study will allow to determine joint bleeding caused by applied physiotherapy&#xD;
      treatment.&#xD;
&#xD;
      Expected results: First, it is intended to demonstrate the safety of this physiotherapy&#xD;
      technique in patients with hemophilia. Likewise, an improvement in the perception of elbow&#xD;
      pain and joint mobility is expected. An improved functionality of the upper limb is also&#xD;
      foreseen and with it, an enhanced perception of quality of life of these patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2018</start_date>
  <completion_date type="Actual">February 15, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline elbow joint bleeding frequency after treatment and at 3 months</measure>
    <time_frame>Screening visit, within the first seven days after treatment and after three months follow-up visit</time_frame>
    <description>After the first session of physiotherapy patients will be given a self-register where they can record all the observations they feel (from hematomas or hemarthros, to any other discomfort or perception). Similarly, the principal investigator of the study will monitor all patients within 48 hours after each physical therapy session.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline range of motion of elbow after treatment and at 3 months</measure>
    <time_frame>Screening visit, within the first seven days after treatment and after three months follow-up visit</time_frame>
    <description>Change from range of movement of elbow during treatment and follow-up period at 3 months. The range of motion of the elbow joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by Felipe Querol.&#xD;
Measurement instrument: universal goniometer with the protocol to measurement for patients with hemophilia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline elbow joint status after treatment and at 3 months</measure>
    <time_frame>Screening visit, within the first seven days after treatment and after three months follow-up visit</time_frame>
    <description>Change from elbow joint status during treatment and follow-up period at 3 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline joint pain of elbow after treatment and at 3 months</measure>
    <time_frame>Screening visit, within the first seven days after treatment and after three months follow-up visit</time_frame>
    <description>Change from joint pain of ankle during treatment and follow-up period at 3 months.The perception of ankle pain will be measured using visual analog scale (scale 0-10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline upper limb functionality after treatment and at 3 months</measure>
    <time_frame>Screening visit, within the first seven days after treatment and after three months follow-up visit</time_frame>
    <description>Change from upper limb functionality during treatment and follow-up period at 3 months. The perception of ankle pain will be measured using DASH Questionnaire. The Spanish version of this scale used internationally will evaluate upper limb functionality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline quality of life after treatment and at 3 months</measure>
    <time_frame>Screening visit, within the first seven days after treatment and after three months follow-up visit</time_frame>
    <description>Change from quality of life during treatment and follow-up period at 3 months. The quality of life perception will be measured using SF-36 Questionnaire. This scale will assess the perception of quality of life of patients included in the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Hemophilia</condition>
  <arm_group>
    <arm_group_label>Expermiental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients included in the experimental group should be on prophylactic treatment with FVIII / FIX concentrates. Likewise, the factor should be administered on the same day that they receive each of the fascial therapy treatment sessions. Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects included in the control group will not receive physical therapy through fascial therapy and will continue with their usual routine of physical activity and exercise, and with the same pharmacological treatment regimen with FVIII / FIX. At the end of the study period the intervention will be applied under the same conditions as the experimental group, analyzing the overall sample at the end of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental group</intervention_name>
    <description>Longitudinal surface sliding maneuver over the superficial fascia in the anterior region of the arm and the forearm. Applied in 3 strokes.&#xD;
Transverse sliding of the flexor muscles of the wrist and fingers.&#xD;
Transverse sliding for the biceps brachii muscle.&#xD;
Longitudinal surface sliding over the superficial fascia in the posterior arm region.&#xD;
Transverse sliding over the brachial triceps tendon.&#xD;
Transverse sliding for the pectoralis major muscle.&#xD;
Transverse sliding for the posterior axillary region pectoralis major muscle.&#xD;
Induction of the posterior axillary fold.&#xD;
Induction (crossed hands over the brachial region and forearm).&#xD;
Maneuver of transverse planes for the cervicothoracic region.&#xD;
Upper limb telescopic maneuver.</description>
    <arm_group_label>Expermiental group</arm_group_label>
    <other_name>Fascial therapy group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with hemophilia A and B&#xD;
&#xD;
          -  Patients adults (over 18 years)&#xD;
&#xD;
          -  Patients diagnosed with hemophilic arthropathy of the elbow (by clinical assessment&#xD;
             with the Hemophilia Joint Health Score)&#xD;
&#xD;
          -  Patients pn prophylactic treatment with FVIII / FIX concentrates.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without ambulation ability&#xD;
&#xD;
          -  Patients with inhibitors&#xD;
&#xD;
          -  Patients with neurological or cognitive alterations that impede the comprehension of&#xD;
             the questionnaires and physical tests&#xD;
&#xD;
          -  Patients who have not signed the informed consent document.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Victoria Eugenia Foundation</name>
      <address>
        <city>Madrid</city>
        <state>Madird</state>
        <zip>28029</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Real Fundación Victoria Eugenia</investigator_affiliation>
    <investigator_full_name>Rubén Cuesta-Barriuso, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hemophilia</keyword>
  <keyword>Elbow</keyword>
  <keyword>Arthropathy</keyword>
  <keyword>Joint pain</keyword>
  <keyword>Range of motion</keyword>
  <keyword>Myofascial techniques</keyword>
  <keyword>Safety patients</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Functionality</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03009591
org study id: HeL-Fascial
nct id: NCT03009591
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds,
      especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints,
      causing a progressive joint deterioration. Secondary disorders to this joint degeneration
      include: biomechanical alterations, loss of range of movement and periarticular muscle
      atrophy.

      Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of a
      treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of
      the elbow.

      Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy in
      patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with
      hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients
      will be recruited in 6 centers, from different regions of Spain.

      Intervention: Each session will last approximately 50 minutes, with three physiotherapy
      sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers
      that must be administered bilaterally:

      Measuring instruments and study variables: goniometric evaluation (range of movement); visual
      analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH Questionnaire
      (functionality of upper limbs); SF-36 Questionnaire (perception of quality of life). At the
      same time, the study will allow to determine joint bleeding caused by applied physiotherapy
      treatment.

      Expected results: First, it is intended to demonstrate the safety of this physiotherapy
      technique in patients with hemophilia. Likewise, an improvement in the perception of elbow
      pain and joint mobility is expected. An improved functionality of the upper limb is also
      foreseen and with it, an enhanced perception of quality of life of these patients.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline elbow joint bleeding frequency after treatment and at 3 months
time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
description: After the first session of physiotherapy patients will be given a self-register where they can record all the observations they feel (from hematomas or hemarthros, to any other discomfort or perception). Similarly, the principal investigator of the study will monitor all patients within 48 hours after each physical therapy session.
measure: Change from baseline range of motion of elbow after treatment and at 3 months
time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
description: Change from range of movement of elbow during treatment and follow-up period at 3 months. The range of motion of the elbow joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by Felipe Querol.
Measurement instrument: universal goniometer with the protocol to measurement for patients with hemophilia
measure: Change from baseline elbow joint status after treatment and at 3 months
time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
description: Change from elbow joint status during treatment and follow-up period at 3 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).
measure: Change from baseline joint pain of elbow after treatment and at 3 months
time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
description: Change from joint pain of ankle during treatment and follow-up period at 3 months.The perception of ankle pain will be measured using visual analog scale (scale 0-10).
measure: Change from baseline upper limb functionality after treatment and at 3 months
time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
description: Change from upper limb functionality during treatment and follow-up period at 3 months. The perception of ankle pain will be measured using DASH Questionnaire. The Spanish version of this scale used internationally will evaluate upper limb functionality.
measure: Change from baseline quality of life after treatment and at 3 months
time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
description: Change from quality of life during treatment and follow-up period at 3 months. The quality of life perception will be measured using SF-36 Questionnaire. This scale will assess the perception of quality of life of patients included in the study.
arm group label: Expermiental group
arm group type: Experimental
description: All patients included in the experimental group should be on prophylactic treatment with FVIII / FIX concentrates. Likewise, the factor should be administered on the same day that they receive each of the fascial therapy treatment sessions. Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:
arm group label: Control group
arm group type: No Intervention
description: Subjects included in the control group will not receive physical therapy through fascial therapy and will continue with their usual routine of physical activity and exercise, and with the same pharmacological treatment regimen with FVIII / FIX. At the end of the study period the intervention will be applied under the same conditions as the experimental group, analyzing the overall sample at the end of the study.
intervention type: Other
intervention name: Experimental group
description: Longitudinal surface sliding maneuver over the superficial fascia in the anterior region of the arm and the forearm. Applied in 3 strokes.
Transverse sliding of the flexor muscles of the wrist and fingers.
Transverse sliding for the biceps brachii muscle.
Longitudinal surface sliding over the superficial fascia in the posterior arm region.
Transverse sliding over the brachial triceps tendon.
Transverse sliding for the pectoralis major muscle.
Transverse sliding for the posterior axillary region pectoralis major muscle.
Induction of the posterior axillary fold.
Induction (crossed hands over the brachial region and forearm).
Maneuver of transverse planes for the cervicothoracic region.
Upper limb telescopic maneuver.
arm group label: Expermiental group
other name: Fascial therapy group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Real Fundación Victoria Eugenia
investigator full name: Rubén Cuesta-Barriuso, PhD
investigator title: Principal Investigator
mesh term: Joint Diseases
mesh term: Hemophilia A
sharing ipd: No