Musculoskeletal DisordersNCT02218749
Triaging Patients With Musculoskeletal Disorders Directly to Physiotherapists at Primary Health Care Clinics.
A study testing Initially triaged to physiotherapist and Initially triaged to physician in people with Musculoskeletal Disorders, run by Göteborg University at 3 sites in Sweden.
Trial summary
The purpose of this study is to determine whether initial triaging to physiotherapists of patients with musculoskeletal disorders who seek health care from primary care clinics affects the patients health and/or health care utilization differently than initial consultation with a general practitioner. Read more about this study
- Who is it for?
- Ages 16 to 67 years
- Conditions the study is for
- Musculoskeletal Disorders
- What is being tested?
- Initially triaged to physiotherapist and Initially triaged to physician
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesSweden
- Study dates
- Aug 2014to Mar 2019
- 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 16 to 67 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- seeking primary care clinic for musculoskeletal disorder
- age 16-67 years
- speaks enough Swedish or English to understand the patient information and complete the questionnaires
- triage nurse judges it suitable to triage participant to physiotherapist
Who cannot join
- has received treatment at the clinic by physician or physiotherapist during the preceding month for the same problem
- seeking for chronic musculoskeletal disorder with unchanged symptoms the latest 3 months and for which the patient has already tried physiotherapy
- seeking for help with medical aids other than crutches
- is in need of home care
- has been included in the study earlier
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Närhälsan Eriksberg Health centre
Gothenburg, 417 64
Närhälsan Biskopsgården Health centre
Gothenburg, 418 33
Närhälsan Kyrkbyn Health centre
Gothenburg, 418 73
About this study
Official title: The Effects of Triaging Patients With Musculoskeletal Disorders Directly to Physiotherapists at Primary Health Care Clinics: a Pilot Study and Randomized Controlled Trial.
The purpose of this study is to determine whether initial triaging to physiotherapists of patients with musculoskeletal disorders who seek health care from primary care clinics affects the patients health and/or health care utilization differently than initial consultation with a general practitioner.
- Conditions
- Musculoskeletal Disorders
- Being tested
- Initially triaged to physiotherapist, Initially triaged to physician
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initially triaged to physiotherapistOther
Initially triaged to physicianOther
| Study group | Role | What they receive |
|---|---|---|
| Initially triaged to physiotherapist | Experimental | Initially triaged to physiotherapist Receives: Other: Initially triaged to physiotherapist |
| Initially triaged to physician | Active comparator | Initially triaged to physician Receives: Other: Initially triaged to physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of physician visits
Measured: 1 year
Change in self-evaluated level of pain latest week (0-10 scale)
Measured: 3 months
Secondary outcomes (26)
Number of physiotherapist visits
Measured: 1 year
Number of days of sick-leave
Measured: 1 year
Number of referrals for external examinations and to specialists
Measured: 1 year
Changes in health-related quality of life measured with EQ-5D
Measured: 2 weeks
Changes in health-related quality of life measured with EQ-5D
Measured: 3 months
Changes in health-related quality of life measured with EQ-5D
Measured: 6 months
Changes in health-related quality of life measured with EQ-5D
Measured: 1 year
Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
Measured: 2 weeks
Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
Measured: 3 months
Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
Measured: 6 months
Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
Measured: 1 year
Change in experience of functional difficulty measured with DRI scale
Measured: 2 weeks
Change in experience of functional difficulty measured with DRI scale
Measured: 3 months
Change in experience of functional difficulty measured with DRI scale
Measured: 6 months
Change in experience of functional difficulty measured with DRI scale
Measured: 1 year
Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
Measured: 2 weeks
Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
Measured: 3 months
Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
Measured: 6 months
Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
Measured: 1 year
Change in self-evaluated level of pain latest week (0-10 scale)
Measured: 2 weeks
Change in self-evaluated level of pain latest week (0-10 scale)
Measured: 6 months
Change in self-evaluated level of pain latest week (0-10 scale)
Measured: 1 year
Prescriptions för analgesics for the actual musculoskeletal disorder
Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.
Measured: 2 weeks
Prescriptions för analgesics for the actual musculoskeletal disorder
Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.
Measured: 3 months
Prescriptions för analgesics for the actual musculoskeletal disorder
Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.
Measured: 6 months
Prescriptions för analgesics for the actual musculoskeletal disorder
Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2018
- Study completionMar 2019
Why it stopped: Organizational barriers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DisordersStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Närhälsan Primary care Research and Development
- Responsible party
- Sponsor
- Investigators
- Lena Bornhöft, MSc, RPT, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218749
- Sponsor's protocol ID
- 148611
- Other IDs
- VGFOUGSB-421881
- Status last verified
- Apr 2019
- First submitted
- 15 Aug 2014
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Bornhoft L, Thorn J, Svensson M, Nordeman L, Eggertsen R, Larsson MEH. More cost-effective management of patients with musculoskeletal disorders in primary care after direct triaging to physiotherapists for initial assessment compared to initial general practitioner assessment. BMC Musculoskelet Disord. 2019 May 1;20(1):186. doi: 10.1186/s12891-019-2553-9.
PubMed 31043169
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Triaging Patients With Musculoskeletal Disorders Directly to Physiotherapists at Primary Health Care Clinics: a Pilot Study and Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02218749
- Acronym / sponsor ID
- 148611
- Conditions
- Musculoskeletal Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Organizational barriers
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Närhälsan Primary care Research and Development
- Study start
- Aug 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 18 Aug 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.
The purpose of this study is to determine whether initial triaging to physiotherapists of patients with musculoskeletal disorders who seek health care from primary care clinics affects the patients health and/or health care utilization differently than initial consultation with a general practitioner.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initially triaged to physiotherapist | Experimental | Other: Initially triaged to physiotherapistInitially triaged to physiotherapist |
| Initially triaged to physician | Active comparator | Other: Initially triaged to physicianInitially triaged to physician |
Who may qualify
- Ages
- 16 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- seeking primary care clinic for musculoskeletal disorder
- age 16-67 years
- speaks enough Swedish or English to understand the patient information and complete the questionnaires
- triage nurse judges it suitable to triage participant to physiotherapist
Key exclusion criteria (5 listed)
- has received treatment at the clinic by physician or physiotherapist during the preceding month for the same problem
- seeking for chronic musculoskeletal disorder with unchanged symptoms the latest 3 months and for which the patient has already tried physiotherapy
- seeking for help with medical aids other than crutches
- is in need of home care
- has been included in the study earlier
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 |
|---|---|---|
| Initially triaged to physiotherapist | Other | Initially triaged to physiotherapist |
| Initially triaged to physician | Other | Initially triaged to physician |
Primary outcome
Number of physician visits
Time frame: 1 year
Change in self-evaluated level of pain latest week (0-10 scale)
Time frame: 3 months
26 secondary outcomes
Number of physiotherapist visits
Time frame: 1 year
Number of days of sick-leave
Time frame: 1 year
Number of referrals for external examinations and to specialists
Time frame: 1 year
Changes in health-related quality of life measured with EQ-5D
Time frame: 2 weeks
Changes in health-related quality of life measured with EQ-5D
Time frame: 3 months
Changes in health-related quality of life measured with EQ-5D
Time frame: 6 months
Changes in health-related quality of life measured with EQ-5D
Time frame: 1 year
Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
Time frame: 2 weeks
Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
Time frame: 3 months
Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
Time frame: 6 months
Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
Time frame: 1 year
Change in experience of functional difficulty measured with DRI scale
Time frame: 2 weeks
Change in experience of functional difficulty measured with DRI scale
Time frame: 3 months
Change in experience of functional difficulty measured with DRI scale
Time frame: 6 months
Change in experience of functional difficulty measured with DRI scale
Time frame: 1 year
Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
Time frame: 2 weeks
Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
Time frame: 3 months
Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
Time frame: 6 months
Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
Time frame: 1 year
Change in self-evaluated level of pain latest week (0-10 scale)
Time frame: 2 weeks
Change in self-evaluated level of pain latest week (0-10 scale)
Time frame: 6 months
Change in self-evaluated level of pain latest week (0-10 scale)
Time frame: 1 year
Prescriptions för analgesics for the actual musculoskeletal disorder
Time frame: 2 weeks
Prescriptions för analgesics for the actual musculoskeletal disorder
Time frame: 3 months
Prescriptions för analgesics for the actual musculoskeletal disorder
Time frame: 6 months
Prescriptions för analgesics for the actual musculoskeletal disorder
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Organizational barriers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Derived from this study: PubMed 31043169Bornhoft L, Thorn J, Svensson M, Nordeman L, Eggertsen R, Larsson MEH. More cost-effective management of patients with musculoskeletal disorders in primary care after direct triaging to physiotherapists for initial assessment compared to initial general practitioner assessment. BMC Musculoskelet Disord. 2019 May 1;20(1):186. doi: 10.1186/s12891-019-2553-9.
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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.
Lena Bornhöft, MSc, RPT principal investigator
Göteborg University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initially triaged to physiotherapist and Initially triaged to physician in people with Musculoskeletal Disorders, run by Göteborg University at 3 sites in Sweden.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Organizational barriers). Results are not available in the source record.
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 physician visits (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT02218749, which also lists 1 linked publication.
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 26 Apr 2019.