<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/NCT02265172</url>
  </required_header>
  <id_info>
    <org_study_id>EPN GBG 328-09</org_study_id>
    <nct_id>NCT02265172</nct_id>
  </id_info>
  <brief_title>Physiotherapy Assessment of Patients Referred to Orthopaedic Surgeon</brief_title>
  <official_title>Does Orthopaedic Manual Therapy Assessment of Patients Referred to Orthopaedic Surgeon Bring Any Changes to Referral Routines, Patient Satisfaction and Health-related Variables?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vastra Gotaland Region</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many patients with musculoskeletal pain in primary healthcare are referred to orthopaedic&#xD;
      surgeon, however, a relatively low percentage of these patients are considered suitable for&#xD;
      orthopaedic intervention.&#xD;
&#xD;
      Physiotherapists are suitable for musculoskeletal assessments and are used as such in many&#xD;
      countries i.e. Advanced Practice Physiotherapists or Extended Scope Physiotherapists,&#xD;
      however, this is not an existing model of care in Sweden. To be able to consider this model&#xD;
      for implementation in Sweden it is necessary to evaluate it from a healthcare as well as from&#xD;
      a patient perspective.&#xD;
&#xD;
      The study is a randomised controlled trial. Overall aim is to evaluate if a orthopaedic&#xD;
      manual therapy assessment (physiotherapy) assessment of patients referred to orthopaedic&#xD;
      surgeon bring any changes to referral routines, patient satisfaction and health-related&#xD;
      variables when compared to standard practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomised controlled trial. Overall aim is to evaluate if a orthopaedic&#xD;
      manual therapy assessment (physiotherapy) assessment of patients referred to orthopaedic&#xD;
      surgeon bring any changes to referral routines, patient satisfaction and health-related&#xD;
      variables when compared to standard practice. Patients were randomised to either&#xD;
      physiotherapy assessment or standard practice (orthopaedic surgeon assessment).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2009</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">January 2011</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of referrals after consultation as a measure of Management outcome</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Scores on the questionnaire Quality from the Patient Perspective as a measure of Patient satisfaction</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores on the EuroQol-5D as a measure of Health-related quality of life</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores on the Pain Disability Index as a measure of Pain-related disability</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of sick-leave days</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost per quality adjusted life year (QUALY) gained as a measure of cost-utitily</measure>
    <time_frame>12 months</time_frame>
    <description>QUALYs are calculated from the EuroQol-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores on the Pain Belief Screening Instrument as a measure of risk for long-term disability</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Musculoskeletal Pain</condition>
  <arm_group>
    <arm_group_label>Physiotherapy screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Screening consisted of a 60-min appointment including assessment, diagnosis and management. The patients received advice regarding ergonomics, exercises and/or treatment when needed. Management options were;&#xD;
Referral for orthopaedic surgeon consultation.&#xD;
Referral back to the patient's General Practitioner.&#xD;
Referral for further investigation.&#xD;
Referral to the physiotherapy or the occupational therapy clinic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard practice (orthopaedic surgeon)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Appointment was 15 min, including assessment, diagnosis and management. The patients received advice, prescriptions or injections when needed. Management options were;&#xD;
Referral for orthopaedic intervention.&#xD;
Referral back to the patient's General Practitioner.&#xD;
Referral for further investigation.&#xD;
Referral to the physiotherapy or the occupational therapy clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physiotherapy screening</intervention_name>
    <description>Physiotherapy screening.</description>
    <arm_group_label>Physiotherapy screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard practice</intervention_name>
    <description>Orthopaedic surgeon assessment</description>
    <arm_group_label>Standard practice (orthopaedic surgeon)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients referred for orthopaedic surgeon with sub acute (four weeks to three months)&#xD;
             or chronic (&gt;three months) musculoskeletal pain who had the ability to understand&#xD;
             written and spoken Swedish.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosed hallux valgus, ganglion or trigger finger.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Larsson, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Närhalsan Research and development, Region of Västra Götaland</affiliation>
  </overall_official>
  <results_reference>
    <citation>Samsson K, Larsson ME. Physiotherapy screening of patients referred for orthopaedic consultation in primary healthcare - a randomised controlled trial. Man Ther. 2014 Oct;19(5):386-91. doi: 10.1016/j.math.2013.10.004. Epub 2013 Oct 29.</citation>
    <PMID>24246908</PMID>
  </results_reference>
  <results_reference>
    <citation>Samsson KS, Larsson ME. Physiotherapy triage assessment of patients referred for orthopaedic consultation - Long-term follow-up of health-related quality of life, pain-related disability and sick leave. Man Ther. 2015 Feb;20(1):38-45. doi: 10.1016/j.math.2014.06.009. Epub 2014 Jul 15.</citation>
    <PMID>25088308</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 24, 2014</last_update_submitted>
  <last_update_submitted_qc>October 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physiotherapy</keyword>
  <keyword>Orthopaedic</keyword>
  <keyword>Primary care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Pain</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/NCT02265172
org study id: EPN GBG 328-09
nct id: NCT02265172
lead sponsor: 
has dmc: No
Many patients with musculoskeletal pain in primary healthcare are referred to orthopaedic
      surgeon, however, a relatively low percentage of these patients are considered suitable for
      orthopaedic intervention.

      Physiotherapists are suitable for musculoskeletal assessments and are used as such in many
      countries i.e. Advanced Practice Physiotherapists or Extended Scope Physiotherapists,
      however, this is not an existing model of care in Sweden. To be able to consider this model
      for implementation in Sweden it is necessary to evaluate it from a healthcare as well as from
      a patient perspective.

      The study is a randomised controlled trial. Overall aim is to evaluate if a orthopaedic
      manual therapy assessment (physiotherapy) assessment of patients referred to orthopaedic
      surgeon bring any changes to referral routines, patient satisfaction and health-related
      variables when compared to standard practice.
The study is a randomised controlled trial. Overall aim is to evaluate if a orthopaedic
      manual therapy assessment (physiotherapy) assessment of patients referred to orthopaedic
      surgeon bring any changes to referral routines, patient satisfaction and health-related
      variables when compared to standard practice. Patients were randomised to either
      physiotherapy assessment or standard practice (orthopaedic surgeon assessment).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of referrals after consultation as a measure of Management outcome
time frame: 12 months
measure: Scores on the questionnaire Quality from the Patient Perspective as a measure of Patient satisfaction
time frame: 30 days
measure: Scores on the EuroQol-5D as a measure of Health-related quality of life
time frame: 12 months
measure: Scores on the Pain Disability Index as a measure of Pain-related disability
time frame: 12 months
measure: Number of sick-leave days
time frame: 12 months
measure: Cost per quality adjusted life year (QUALY) gained as a measure of cost-utitily
time frame: 12 months
description: QUALYs are calculated from the EuroQol-5D
measure: Scores on the Pain Belief Screening Instrument as a measure of risk for long-term disability
time frame: 12 months
arm group label: Physiotherapy screening
arm group type: Experimental
description: Screening consisted of a 60-min appointment including assessment, diagnosis and management. The patients received advice regarding ergonomics, exercises and/or treatment when needed. Management options were;
Referral for orthopaedic surgeon consultation.
Referral back to the patient's General Practitioner.
Referral for further investigation.
Referral to the physiotherapy or the occupational therapy clinic.
arm group label: Standard practice (orthopaedic surgeon)
arm group type: Active Comparator
description: Appointment was 15 min, including assessment, diagnosis and management. The patients received advice, prescriptions or injections when needed. Management options were;
Referral for orthopaedic intervention.
Referral back to the patient's General Practitioner.
Referral for further investigation.
Referral to the physiotherapy or the occupational therapy clinic.
intervention type: Procedure
intervention name: Physiotherapy screening
description: Physiotherapy screening.
arm group label: Physiotherapy screening
intervention type: Procedure
intervention name: Standard practice
description: Orthopaedic surgeon assessment
arm group label: Standard practice (orthopaedic surgeon)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 67 Years
healthy volunteers: No
last name: Maria Larsson, PhD
role: Study Director
affiliation: Närhalsan Research and development, Region of Västra Götaland
citation: Samsson K, Larsson ME. Physiotherapy screening of patients referred for orthopaedic consultation in primary healthcare - a randomised controlled trial. Man Ther. 2014 Oct;19(5):386-91. doi: 10.1016/j.math.2013.10.004. Epub 2013 Oct 29.
PMID: 24246908
citation: Samsson KS, Larsson ME. Physiotherapy triage assessment of patients referred for orthopaedic consultation - Long-term follow-up of health-related quality of life, pain-related disability and sick leave. Man Ther. 2015 Feb;20(1):38-45. doi: 10.1016/j.math.2014.06.009. Epub 2014 Jul 15.
PMID: 25088308
responsible party type: Sponsor
mesh term: Musculoskeletal Pain