Musculoskeletal PainNCT02265172
Physiotherapy Assessment of Patients Referred to Orthopaedic Surgeon
A study testing Physiotherapy screening and Standard practice in people with Musculoskeletal Pain, run by Vastra Gotaland Region.
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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Physiotherapy screening and Standard practice
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- diagnosed hallux valgus, ganglion or trigger finger.
About this study
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?
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.
Read the 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).
- Conditions
- Musculoskeletal Pain
- Being tested
- Physiotherapy screening, Standard practice
- Keywords
- Physiotherapy, Orthopaedic, Primary care
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy screeningProcedure or surgery
Physiotherapy screening.
Standard practiceProcedure or surgery
Orthopaedic surgeon assessment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of referrals after consultation as a measure of Management outcome
Measured: 12 months
Secondary outcomes (6)
Scores on the questionnaire Quality from the Patient Perspective as a measure of Patient satisfaction
Measured: 30 days
Scores on the EuroQol-5D as a measure of Health-related quality of life
Measured: 12 months
Scores on the Pain Disability Index as a measure of Pain-related disability
Measured: 12 months
Number of sick-leave days
Measured: 12 months
Cost per quality adjusted life year (QUALY) gained as a measure of cost-utitily
QUALYs are calculated from the EuroQol-5D
Measured: 12 months
Scores on the Pain Belief Screening Instrument as a measure of risk for long-term disability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startAug 2009
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Maria Larsson, PhD, Study director, Närhalsan Research and development, Region of Västra Götaland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265172
- Sponsor's protocol ID
- EPN GBG 328-09
- Status last verified
- Sep 2014
- First submitted
- 6 Oct 2014
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24246908Samsson 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.
PubMed 25088308Samsson 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.
PubMed 39757368Samsson 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.
PubMed 27286829
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02265172
- Acronym / sponsor ID
- EPN GBG 328-09
- Conditions
- Musculoskeletal Pain
- Keywords
- Physiotherapy, Orthopaedic, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Aug 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy screening | Experimental | Procedure: Physiotherapy screeningScreening 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. |
| Standard practice (orthopaedic surgeon) | Active comparator | Procedure: Standard practiceAppointment 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. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- diagnosed hallux valgus, ganglion or trigger finger.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy screeningPhysiotherapy screening. | Procedure or surgery | Physiotherapy screening |
| Standard practiceOrthopaedic surgeon assessment | Procedure or surgery | Standard practice (orthopaedic surgeon) |
Primary outcome
Number of referrals after consultation as a measure of Management outcome
Time frame: 12 months
6 secondary outcomes
Scores on the questionnaire Quality from the Patient Perspective as a measure of Patient satisfaction
Time frame: 30 days
Scores on the EuroQol-5D as a measure of Health-related quality of life
Time frame: 12 months
Scores on the Pain Disability Index as a measure of Pain-related disability
Time frame: 12 months
Number of sick-leave days
Time frame: 12 months
Cost per quality adjusted life year (QUALY) gained as a measure of cost-utitily
Time frame: 12 months
Scores on the Pain Belief Screening Instrument as a measure of risk for long-term disability
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
- Results publication: PubMed 24246908Samsson 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 publication: PubMed 25088308Samsson 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.
- Derived from this study: PubMed 39757368Samsson 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.
- Derived from this study: PubMed 27286829Samsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Larsson, PhD study director
Närhalsan Research and development, Region of Västra Götaland
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy screening and Standard practice in people with Musculoskeletal Pain, run by Vastra Gotaland Region.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of referrals after consultation as a measure of Management outcome (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02265172, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2014.