NCT02265172

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
Last Updated

October 27, 2014

Status Verified

September 1, 2014

Enrollment Period

1.4 years

First QC Date

October 6, 2014

Last Update Submit

October 24, 2014

Conditions

Keywords

PhysiotherapyOrthopaedicPrimary care

Outcome Measures

Primary Outcomes (1)

  • Number of referrals after consultation as a measure of Management outcome

    12 months

Secondary Outcomes (6)

  • Scores on the questionnaire Quality from the Patient Perspective as a measure of Patient satisfaction

    30 days

  • Scores on the EuroQol-5D as a measure of Health-related quality of life

    12 months

  • Scores on the Pain Disability Index as a measure of Pain-related disability

    12 months

  • Number of sick-leave days

    12 months

  • Cost per quality adjusted life year (QUALY) gained as a measure of cost-utitily

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Physiotherapy screening

EXPERIMENTAL

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

Standard practice (orthopaedic surgeon)

ACTIVE COMPARATOR

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

Interventions

Physiotherapy screening.

Physiotherapy screening

Orthopaedic surgeon assessment

Standard practice (orthopaedic surgeon)

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • diagnosed hallux valgus, ganglion or trigger finger.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

  • 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.

  • Samsson KS, Bernhardsson S, Sandborgh M, Larsson MEH. The association between screened psychological risk for disability and appropriateness of orthopedic surgery in patients with musculoskeletal disorders - data from a Swedish RCT in primary care 2009-2011. Physiother Theory Pract. 2025 Aug;41(8):1579-1586. doi: 10.1080/09593985.2024.2448709. Epub 2025 Jan 5.

  • 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.

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Larsson, PhD

    Närhalsan Research and development, Region of Västra Götaland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 15, 2014

Study Start

August 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

October 27, 2014

Record last verified: 2014-09