Triaging Patients With Musculoskeletal Disorders Directly to Physiotherapists at Primary Health Care Clinics.

April 25, 2019 updated by: Göteborg University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 417 64
        • Närhälsan Eriksberg Health centre
      • Gothenburg, Sweden, 418 33
        • Närhälsan Biskopsgården Health centre
      • Gothenburg, Sweden, 418 73
        • Närhälsan Kyrkbyn Health centre

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 67 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Initially triaged to physiotherapist
Other: Initially triaged to physiotherapist
Active Comparator: Initially triaged to physician
Other: Initially triaged to physician

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of physician visits
Time Frame: 1 year
1 year
Change in self-evaluated level of pain latest week (0-10 scale)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of physiotherapist visits
Time Frame: 1 year
1 year
Number of days of sick-leave
Time Frame: 1 year
1 year
Number of referrals for external examinations and to specialists
Time Frame: 1 year
1 year
Changes in health-related quality of life measured with EQ-5D
Time Frame: 2 weeks
2 weeks
Changes in health-related quality of life measured with EQ-5D
Time Frame: 3 months
3 months
Changes in health-related quality of life measured with EQ-5D
Time Frame: 6 months
6 months
Changes in health-related quality of life measured with EQ-5D
Time Frame: 1 year
1 year
Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
Time Frame: 2 weeks
2 weeks
Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
Time Frame: 3 months
3 months
Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
Time Frame: 6 months
6 months
Changes in attitudes regarding responsibility for musculoskeletal disorders measured with ARM scale
Time Frame: 1 year
1 year
Change in experience of functional difficulty measured with DRI scale
Time Frame: 2 weeks
2 weeks
Change in experience of functional difficulty measured with DRI scale
Time Frame: 3 months
3 months
Change in experience of functional difficulty measured with DRI scale
Time Frame: 6 months
6 months
Change in experience of functional difficulty measured with DRI scale
Time Frame: 1 year
1 year
Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
Time Frame: 2 weeks
2 weeks
Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
Time Frame: 3 months
3 months
Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
Time Frame: 6 months
6 months
Risk for developing chronic pain measured with the Örebro Musculoskeletal Pain Screening Questionnaire
Time Frame: 1 year
1 year
Change in self-evaluated level of pain latest week (0-10 scale)
Time Frame: 2 weeks
2 weeks
Change in self-evaluated level of pain latest week (0-10 scale)
Time Frame: 6 months
6 months
Change in self-evaluated level of pain latest week (0-10 scale)
Time Frame: 1 year
1 year
Prescriptions för analgesics for the actual musculoskeletal disorder
Time Frame: 2 weeks
Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.
2 weeks
Prescriptions för analgesics for the actual musculoskeletal disorder
Time Frame: 3 months
Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.
3 months
Prescriptions för analgesics for the actual musculoskeletal disorder
Time Frame: 6 months
Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.
6 months
Prescriptions för analgesics for the actual musculoskeletal disorder
Time Frame: 1 year
Received any prescriptions. Number of prescriptions. Number of occasions prescriptions were received. Type of prescription(s) received.
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Göteborg University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Närhälsan Primary care Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lena Bornhöft, MSc, RPT, Göteborg University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 148611
  • VGFOUGSB-421881 (Other Grant/Funding Number: FoU primärvård Göteborg och Södra Bohuslän)

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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