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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02265172
Other study ID # EPN GBG 328-09
Secondary ID
Status Completed
Phase N/A
First received October 6, 2014
Last updated October 24, 2014
Start date August 2009
Est. completion date January 2012

Study information

Verified date September 2014
Source Vastra Gotaland Region
Contact n/a
Is FDA regulated No
Health authority Sweden: Swedish Research Council
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 208
Est. completion date January 2012
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 67 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
Physiotherapy screening
Physiotherapy screening.
Standard practice
Orthopaedic surgeon assessment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Vastra Gotaland Region

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of referrals after consultation as a measure of Management outcome 12 months No
Secondary Scores on the questionnaire Quality from the Patient Perspective as a measure of Patient satisfaction 30 days No
Secondary Scores on the EuroQol-5D as a measure of Health-related quality of life 12 months No
Secondary Scores on the Pain Disability Index as a measure of Pain-related disability 12 months No
Secondary Number of sick-leave days 12 months No
Secondary Cost per quality adjusted life year (QUALY) gained as a measure of cost-utitily QUALYs are calculated from the EuroQol-5D 12 months No
Secondary Scores on the Pain Belief Screening Instrument as a measure of risk for long-term disability 12 months No
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