NCT02218749

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

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, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

3.6 years

First QC Date

August 15, 2014

Last Update Submit

April 25, 2019

Conditions

Musculoskeletal Disorders

Outcome Measures

Primary Outcomes (2)

  • Number of physician visits

    1 year

  • Change in self-evaluated level of pain latest week (0-10 scale)

    3 months

Secondary Outcomes (26)

  • Number of physiotherapist visits

    1 year

  • Number of days of sick-leave

    1 year

  • Number of referrals for external examinations and to specialists

    1 year

  • Changes in health-related quality of life measured with EQ-5D

    2 weeks

  • Changes in health-related quality of life measured with EQ-5D

    3 months

  • +21 more secondary outcomes

Study Arms (2)

Initially triaged to physiotherapist

EXPERIMENTAL

Initially triaged to physiotherapist

Other: Initially triaged to physiotherapist

Initially triaged to physician

ACTIVE COMPARATOR

Initially triaged to physician

Other: Initially triaged to physician

Interventions

Initially triaged to physiotherapistOTHER
Initially triaged to physiotherapist
Initially triaged to physicianOTHER
Initially triaged to physician

Eligibility Criteria

Age16 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Närhälsan Eriksberg Health centre

Gothenburg, 417 64, Sweden

Location

Närhälsan Biskopsgården Health centre

Gothenburg, 418 33, Sweden

Location

Närhälsan Kyrkbyn Health centre

Gothenburg, 418 73, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 31043169DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Lena Bornhöft, MSc, RPT

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2014

First Posted

August 18, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2019

Last Updated

April 26, 2019

Record last verified: 2019-04

Locations

SE(3)