Physiotherapy Assessment of Patients Referred to Orthopaedic Surgeon

October 24, 2014 updated by: Vastra Gotaland Region

Does Orthopaedic Manual Therapy Assessment of Patients Referred to Orthopaedic Surgeon Bring Any Changes to Referral Routines, Patient Satisfaction and Health-related Variables?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physiotherapy screening

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.
Procedure: Physiotherapy screening
Physiotherapy screening.
Active Comparator: Standard practice (orthopaedic surgeon)

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.
Procedure: Standard practice
Orthopaedic surgeon assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of referrals after consultation as a measure of Management outcome
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores on the questionnaire Quality from the Patient Perspective as a measure of Patient satisfaction
Time Frame: 30 days
30 days
Scores on the EuroQol-5D as a measure of Health-related quality of life
Time Frame: 12 months
12 months
Scores on the Pain Disability Index as a measure of Pain-related disability
Time Frame: 12 months
12 months
Number of sick-leave days
Time Frame: 12 months
12 months
Cost per quality adjusted life year (QUALY) gained as a measure of cost-utitily
Time Frame: 12 months
QUALYs are calculated from the EuroQol-5D
12 months
Scores on the Pain Belief Screening Instrument as a measure of risk for long-term disability
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

  • Study Director: Maria Larsson, PhD, Närhalsan Research and development, Region of Västra Götaland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

October 6, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Estimate)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 24, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPN GBG 328-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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