Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis

June 4, 2020 updated by: Norwegian University of Science and Technology
The purpose of this study is to determine whether patients with spondyloarthritis are more satisfied with a physiotherapy-led outpatient clinic than usual care and whether there is a difference between patients in a physiotherapy-led outpatient clinic and those in usual care regarding disease activity, function and mobility.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • 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

  • Norway
      • Ålesund, Norway, 6026
        • Department of Rheumatology, Ålesund hospital

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

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • confirmed diagnosis spondyloarthritis, ankylosing spondylitis, spondylarthropathy, juvenile ankylosing spondylitis, psoriatic arthritis with affection of the spine
  • age between 18 and 45 (born 1969 - 1996)

Exclusion Criteria:

  • also diagnosed with potentially functionally impairing neuromuscular, neurological or muscular disorders
  • insufficient Norwegian language skills
  • cognitive impairment
  • no sign of inflammation or bone erosions in the sacroiliac joints or in the spine on imaging

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physiotherapy follow-up
Consultation at Physiotherapy-led Outpatient Clinic every 4 month.
Other: Physiotherapy follow-up

Physiotherapy consultation every 4 months containing assessment of the spine and its mobility, including axial joints, assessment of the patients activity profile.

Instruction in home-exercises and recommendations for optimization of activity profile. Information regarding the disease and the importance of physical activity and exercise.
No Intervention: Usual care
Consultation every 4 months, twice a year by rheumatologist as usual, once a year by nurse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Leeds Patient Satisfaction Questionnaire (LSQ)
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame: 8 months
8 months
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: 8 months
8 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time Frame: 8 months
8 months

Collaborators and Investigators

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

Sponsor

Norwegian University of Science and Technology

Collaborators

Helse Møre og Romsdal HF

Investigators

  • Principal Investigator: Ann-Katrin Stensdotter, PhD, Norwegian University of Science and Technology

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)

June 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/1520 (REK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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