<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/NCT02218749</url>
  </required_header>
  <id_info>
    <org_study_id>148611</org_study_id>
    <secondary_id>VGFOUGSB-421881</secondary_id>
    <nct_id>NCT02218749</nct_id>
  </id_info>
  <brief_title>Triaging Patients With Musculoskeletal Disorders Directly to Physiotherapists at Primary Health Care Clinics.</brief_title>
  <official_title>The Effects of Triaging Patients With Musculoskeletal Disorders Directly to Physiotherapists at Primary Health Care Clinics: a Pilot Study and Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Närhälsan Primary care Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Göteborg University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether initial triaging to physiotherapists of&#xD;
      patients with musculoskeletal disorders who seek health care from primary care clinics&#xD;
      affects the patients health and/or health care utilization differently than initial&#xD;
      consultation with a general practitioner.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Organizational barriers&#xD;
  </why_stopped>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">March 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>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of physician visits</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-evaluated level of pain latest week (0-10 scale)</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of physiotherapist visits</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days of sick-leave</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of referrals for external examinations and to specialists</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health-related quality of life measured with EQ-5D</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health-related quality of life measured with EQ-5D</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health-related quality of life measured with EQ-5D</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health-related quality of life measured with EQ-5D</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in experience of functional difficulty measured with DRI scale</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in experience of functional difficulty measured with DRI scale</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in experience of functional difficulty measured with DRI scale</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in experience of functional difficulty measured with DRI scale</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-evaluated level of pain latest week (0-10 scale)</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-evaluated level of pain latest week (0-10 scale)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-evaluated level of pain latest week (0-10 scale)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescriptions för analgesics for the actual musculoskeletal disorder</measure>
    <time_frame>2 weeks</time_frame>
    <description>Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescriptions för analgesics for the actual musculoskeletal disorder</measure>
    <time_frame>3 months</time_frame>
    <description>Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescriptions för analgesics for the actual musculoskeletal disorder</measure>
    <time_frame>6 months</time_frame>
    <description>Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescriptions för analgesics for the actual musculoskeletal disorder</measure>
    <time_frame>1 year</time_frame>
    <description>Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Musculoskeletal Disorders</condition>
  <arm_group>
    <arm_group_label>Initially triaged to physiotherapist</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initially triaged to physiotherapist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Initially triaged to physician</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Initially triaged to physician</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Initially triaged to physiotherapist</intervention_name>
    <arm_group_label>Initially triaged to physiotherapist</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Initially triaged to physician</intervention_name>
    <arm_group_label>Initially triaged to physician</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  seeking primary care clinic for musculoskeletal disorder&#xD;
&#xD;
          -  age 16-67 years&#xD;
&#xD;
          -  speaks enough Swedish or English to understand the patient information and complete&#xD;
             the questionnaires&#xD;
&#xD;
          -  triage nurse judges it suitable to triage participant to physiotherapist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has received treatment at the clinic by physician or physiotherapist during the&#xD;
             preceding month for the same problem&#xD;
&#xD;
          -  seeking for chronic musculoskeletal disorder with unchanged symptoms the latest 3&#xD;
             months and for which the patient has already tried physiotherapy&#xD;
&#xD;
          -  seeking for help with medical aids other than crutches&#xD;
&#xD;
          -  is in need of home care&#xD;
&#xD;
          -  has been included in the study earlier&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lena Bornhöft, MSc, RPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Göteborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Närhälsan Eriksberg Health centre</name>
      <address>
        <city>Gothenburg</city>
        <zip>417 64</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Närhälsan Biskopsgården Health centre</name>
      <address>
        <city>Gothenburg</city>
        <zip>418 33</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Närhälsan Kyrkbyn Health centre</name>
      <address>
        <city>Gothenburg</city>
        <zip>418 73</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>April 25, 2019</last_update_submitted>
  <last_update_submitted_qc>April 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</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/NCT02218749
org study id: 148611
secondary id: VGFOUGSB-421881
nct id: NCT02218749
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether initial triaging to physiotherapists of
      patients with musculoskeletal disorders who seek health care from primary care clinics
      affects the patients health and/or health care utilization differently than initial
      consultation with a general practitioner.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Care Provider, Outcomes Assessor)
measure: Number of physician visits
time frame: 1 year
measure: Change in self-evaluated level of pain latest week (0-10 scale)
time frame: 3 months
measure: Number of physiotherapist visits
time frame: 1 year
measure: Number of days of sick-leave
time frame: 1 year
measure: Number of referrals for external examinations and to specialists
time frame: 1 year
measure: Changes in health-related quality of life measured with EQ-5D
time frame: 2 weeks
measure: Changes in health-related quality of life measured with EQ-5D
time frame: 3 months
measure: Changes in health-related quality of life measured with EQ-5D
time frame: 6 months
measure: Changes in health-related quality of life measured with EQ-5D
time frame: 1 year
measure: Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
time frame: 2 weeks
measure: Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
time frame: 3 months
measure: Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
time frame: 6 months
measure: Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
time frame: 1 year
measure: Change in experience of functional difficulty measured with DRI scale
time frame: 2 weeks
measure: Change in experience of functional difficulty measured with DRI scale
time frame: 3 months
measure: Change in experience of functional difficulty measured with DRI scale
time frame: 6 months
measure: Change in experience of functional difficulty measured with DRI scale
time frame: 1 year
measure: Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
time frame: 2 weeks
measure: Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
time frame: 3 months
measure: Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
time frame: 6 months
measure: Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
time frame: 1 year
measure: Change in self-evaluated level of pain latest week (0-10 scale)
time frame: 2 weeks
measure: Change in self-evaluated level of pain latest week (0-10 scale)
time frame: 6 months
measure: Change in self-evaluated level of pain latest week (0-10 scale)
time frame: 1 year
measure: Prescriptions för analgesics for the actual musculoskeletal disorder
time frame: 2 weeks
description: Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.
measure: Prescriptions för analgesics for the actual musculoskeletal disorder
time frame: 3 months
description: Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.
measure: Prescriptions för analgesics for the actual musculoskeletal disorder
time frame: 6 months
description: Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.
measure: Prescriptions för analgesics for the actual musculoskeletal disorder
time frame: 1 year
description: Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.
arm group label: Initially triaged to physiotherapist
arm group type: Experimental
description: Initially triaged to physiotherapist
arm group label: Initially triaged to physician
arm group type: Active Comparator
description: Initially triaged to physician
intervention type: Other
intervention name: Initially triaged to physiotherapist
arm group label: Initially triaged to physiotherapist
intervention type: Other
intervention name: Initially triaged to physician
arm group label: Initially triaged to physician
criteria: 
gender: All
minimum age: 16 Years
maximum age: 67 Years
healthy volunteers: No
last name: Lena Bornhöft, MSc, RPT
role: Principal Investigator
affiliation: Göteborg University
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Musculoskeletal Diseases