NCT02098694

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

March 25, 2014

Last Update Submit

June 4, 2020

Conditions

Keywords

PhysiotherapyOutpatient clinic

Outcome Measures

Primary Outcomes (1)

  • Leeds Patient Satisfaction Questionnaire (LSQ)

    8 months

Secondary Outcomes (3)

  • Bath Ankylosing Spondylitis Metrology Index (BASMI)

    8 months

  • Bath Ankylosing Spondylitis Functional Index (BASFI)

    8 months

  • Ankylosing Spondylitis Disease Activity Score (ASDAS)

    8 months

Study Arms (2)

Physiotherapy follow-up

EXPERIMENTAL

Consultation at Physiotherapy-led Outpatient Clinic every 4 month.

Other: Physiotherapy follow-up

Usual care

NO INTERVENTION

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

Interventions

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.

Physiotherapy follow-up

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rheumatology, Ålesund hospital

Ålesund, 6026, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SpondylarthritisSpondylitis, AnkylosingSpondylarthropathiesSacroiliitisArthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesAxial SpondyloarthritisAnkylosisPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ann-Katrin Stensdotter, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2014

First Posted

March 28, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations