<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/NCT02200107</url>
  </required_header>
  <id_info>
    <org_study_id>OA-knee 015/2014</org_study_id>
    <nct_id>NCT02200107</nct_id>
  </id_info>
  <brief_title>Integrated Treatment Program for Osteoarthritis of the Knee</brief_title>
  <official_title>Implementing and Evaluating Integrated Medical and Physiotherapy Treatment Program for Osteoarthritis of the Knee by Family Doctors in Primary Care Clinics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the ability to assimilate and implement an&#xD;
      integrated treatment program osteoarthritis of the knee, including the diagnosis and&#xD;
      follow-up by a family physician in primary care clinics, combined with patient self-care&#xD;
      training and physiotherapy program&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Anticipated">December 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in WOMAC ( Western Ontario and McMaster Universities Arthritis Index ) score during participating in the program</measure>
    <time_frame>0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months</time_frame>
    <description>WOMAC score will be evaluated through a questionnaire (validated to Hebrew) at baseline and after a constant time period. For both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program. we will assess the change from baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in VAS pain score during participating in the program</measure>
    <time_frame>0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months</time_frame>
    <description>VAS score will be evaluated through a questionnaire (validated to Hebrew) at baseline and after a constant time period. For both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program. we will assess the change from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the consumption of drugs during participating in the program</measure>
    <time_frame>0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months</time_frame>
    <description>Prescriptions given by family doctor, for treating patient's knee complaints. It will be evaluated by the medical record registration of the patients, at baseline and after a constant time period. For both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Referrals to specialists doctors during participating in the program</measure>
    <time_frame>after 6 weeks since enrollment, and then for intervention group after completing physical therapy program, and for the control group after 6 months</time_frame>
    <description>Referrals given by family doctor. It will be evaluated by the medical record registration of the patients, for both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient satisfaction with treatment</measure>
    <time_frame>6 months after enrollment</time_frame>
    <description>Satisfaction Questionnaire</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">155</enrollment>
  <condition>Osteoarthritis Knee</condition>
  <arm_group>
    <arm_group_label>self management education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>self management education program delivered by family doctor in primary care clinics and during and physical therapy design</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine follow up according to standard practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>self management education</intervention_name>
    <arm_group_label>self management education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active complaint of knee pain&#xD;
&#xD;
          -  Diagnosis of knee osteoarthritis according to X-ray&#xD;
&#xD;
          -  Morning stiffness of less than 30 minutes AND/OR crepitus in active movement&#xD;
&#xD;
          -  Ability to read Hebrew&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous participation in physiotherapy treatment program&#xD;
&#xD;
          -  Gout in knee, rheumatoid arthritis, fibromyalgia&#xD;
&#xD;
          -  Complaints that appear in a knee which was operated in the past&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Severe limitations in mobility&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ohad Avny, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Clalit Health Service</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clalit Health Service</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Keren Cohen-Nahum, MD</last_name>
      <phone>+972523834141</phone>
      <email>kercona@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Ohad Avny, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>April 12, 2015</last_update_submitted>
  <last_update_submitted_qc>April 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteoarthritis Knee</keyword>
  <keyword>Self Care</keyword>
  <keyword>Treatment Outcome</keyword>
  <keyword>Patient Education as Topic</keyword>
  <keyword>Physical Therapy Modalities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <!-- 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/NCT02200107
org study id: OA-knee 015/2014
nct id: NCT02200107
lead sponsor: 
The purpose of this study is to determine the ability to assimilate and implement an
      integrated treatment program osteoarthritis of the knee, including the diagnosis and
      follow-up by a family physician in primary care clinics, combined with patient self-care
      training and physiotherapy program
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in WOMAC ( Western Ontario and McMaster Universities Arthritis Index ) score during participating in the program
time frame: 0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
description: WOMAC score will be evaluated through a questionnaire (validated to Hebrew) at baseline and after a constant time period. For both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program. we will assess the change from baseline.
measure: Change in VAS pain score during participating in the program
time frame: 0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
description: VAS score will be evaluated through a questionnaire (validated to Hebrew) at baseline and after a constant time period. For both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program. we will assess the change from baseline.
measure: Change in the consumption of drugs during participating in the program
time frame: 0, 6 weeks, for intervention group after completing physical therapy program, for the control group after 6 months
description: Prescriptions given by family doctor, for treating patient's knee complaints. It will be evaluated by the medical record registration of the patients, at baseline and after a constant time period. For both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program.
measure: Changes in Referrals to specialists doctors during participating in the program
time frame: after 6 weeks since enrollment, and then for intervention group after completing physical therapy program, and for the control group after 6 months
description: Referrals given by family doctor. It will be evaluated by the medical record registration of the patients, for both groups (intervention and control) after 6 weeks from enrollment and then for the control group after 6 months, and for the intervention group after completing physical therapy program.
measure: Patient satisfaction with treatment
time frame: 6 months after enrollment
description: Satisfaction Questionnaire
arm group label: self management education
arm group type: Experimental
description: self management education program delivered by family doctor in primary care clinics and during and physical therapy design
arm group label: control
arm group type: No Intervention
description: Routine follow up according to standard practice
intervention type: Behavioral
intervention name: self management education
arm group label: self management education
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Ohad Avny, MD
role: Study Chair
affiliation: Clalit Health Service
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee