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Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis

Primary Purpose

Spondylarthritis, Spondylitis, Ankylosing, Spondylarthropathies

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Physiotherapy follow-up
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylarthritis focused on measuring Physiotherapy, Outpatient clinic

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Rheumatology, Ålesund hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physiotherapy follow-up

Usual care

Arm Description

Consultation at Physiotherapy-led Outpatient Clinic every 4 month.

Consultation every 4 months, twice a year by rheumatologist as usual, once a year by nurse.

Outcomes

Primary Outcome Measures

Leeds Patient Satisfaction Questionnaire (LSQ)

Secondary Outcome Measures

Bath Ankylosing Spondylitis Metrology Index (BASMI)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Ankylosing Spondylitis Disease Activity Score (ASDAS)

Full Information

First Posted
March 25, 2014
Last Updated
June 4, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Møre og Romsdal HF
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1. Study Identification

Unique Protocol Identification Number
NCT02098694
Brief Title
Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis
Official Title
Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Møre og Romsdal HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylarthritis, Spondylitis, Ankylosing, Spondylarthropathies, Sacroiliitis, Arthritis, Psoriatic
Keywords
Physiotherapy, Outpatient clinic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy follow-up
Arm Type
Experimental
Arm Description
Consultation at Physiotherapy-led Outpatient Clinic every 4 month.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Consultation every 4 months, twice a year by rheumatologist as usual, once a year by nurse.
Intervention Type
Other
Intervention Name(s)
Physiotherapy follow-up
Intervention Description
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.
Primary Outcome Measure Information:
Title
Leeds Patient Satisfaction Questionnaire (LSQ)
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame
8 months
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame
8 months
Title
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Katrin Stensdotter, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology, Ålesund hospital
City
Ålesund
ZIP/Postal Code
6026
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29573538
Citation
Holoyen PK, Stensdotter AK. Patients with spondyloarthritis are equally satisfied with follow-up by physiotherapist and rheumatologist. Musculoskeletal Care. 2018 Sep;16(3):388-397. doi: 10.1002/msc.1241. Epub 2018 Mar 24.
Results Reference
result

Learn more about this trial

Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis

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