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Physiotherapy Assessment of Patients Referred to Orthopaedic Surgeon

Primary Purpose

Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physiotherapy screening
Standard practice
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Musculoskeletal Pain focused on measuring Physiotherapy, Orthopaedic, Primary care

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients referred for orthopaedic surgeon with sub acute (four weeks to three months) or chronic (>three months) musculoskeletal pain who had the ability to understand written and spoken Swedish.

Exclusion Criteria:

  • diagnosed hallux valgus, ganglion or trigger finger.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Physiotherapy screening

    Standard practice (orthopaedic surgeon)

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Number of referrals after consultation as a measure of Management outcome

    Secondary Outcome Measures

    Scores on the questionnaire Quality from the Patient Perspective as a measure of Patient satisfaction
    Scores on the EuroQol-5D as a measure of Health-related quality of life
    Scores on the Pain Disability Index as a measure of Pain-related disability
    Number of sick-leave days
    Cost per quality adjusted life year (QUALY) gained as a measure of cost-utitily
    QUALYs are calculated from the EuroQol-5D
    Scores on the Pain Belief Screening Instrument as a measure of risk for long-term disability

    Full Information

    First Posted
    October 6, 2014
    Last Updated
    October 24, 2014
    Sponsor
    Vastra Gotaland Region
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02265172
    Brief Title
    Physiotherapy Assessment of Patients Referred to Orthopaedic Surgeon
    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?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Vastra Gotaland Region

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Musculoskeletal Pain
    Keywords
    Physiotherapy, Orthopaedic, Primary care

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    208 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physiotherapy screening
    Arm Type
    Experimental
    Arm 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 Title
    Standard practice (orthopaedic surgeon)
    Arm Type
    Active Comparator
    Arm 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(s)
    Physiotherapy screening
    Intervention Description
    Physiotherapy screening.
    Intervention Type
    Procedure
    Intervention Name(s)
    Standard practice
    Intervention Description
    Orthopaedic surgeon assessment
    Primary Outcome Measure Information:
    Title
    Number of referrals after consultation as a measure of Management outcome
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Scores on the questionnaire Quality from the Patient Perspective as a measure of Patient satisfaction
    Time Frame
    30 days
    Title
    Scores on the EuroQol-5D as a measure of Health-related quality of life
    Time Frame
    12 months
    Title
    Scores on the Pain Disability Index as a measure of Pain-related disability
    Time Frame
    12 months
    Title
    Number of sick-leave days
    Time Frame
    12 months
    Title
    Cost per quality adjusted life year (QUALY) gained as a measure of cost-utitily
    Description
    QUALYs are calculated from the EuroQol-5D
    Time Frame
    12 months
    Title
    Scores on the Pain Belief Screening Instrument as a measure of risk for long-term disability
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    67 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients referred for orthopaedic surgeon with sub acute (four weeks to three months) or chronic (>three months) musculoskeletal pain who had the ability to understand written and spoken Swedish. Exclusion Criteria: diagnosed hallux valgus, ganglion or trigger finger.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Larsson, PhD
    Organizational Affiliation
    Närhalsan Research and development, Region of Västra Götaland
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24246908
    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.
    Results Reference
    result
    PubMed Identifier
    25088308
    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.
    Results Reference
    result
    PubMed Identifier
    27286829
    Citation
    Samsson KS, Bernhardsson S, Larsson ME. Perceived quality of physiotherapist-led orthopaedic triage compared with standard practice in primary care: a randomised controlled trial. BMC Musculoskelet Disord. 2016 Jun 10;17:257. doi: 10.1186/s12891-016-1112-x.
    Results Reference
    derived

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    Physiotherapy Assessment of Patients Referred to Orthopaedic Surgeon

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