SpondylarthritisNCT02098694
Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis
A study testing Physiotherapy follow-up in people with Spondylarthritis and Spondylitis, Ankylosing, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Spondylarthritis, Spondylitis, Ankylosing, Spondylarthropathies
- What is being tested?
- Physiotherapy follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- confirmed diagnosis spondyloarthritis, ankylosing spondylitis, spondylarthropathy, juvenile ankylosing spondylitis, psoriatic arthritis with affection of the spine
- age between 18 and 45 (born 1969 - 1996)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spondylarthritis, Spondylitis, Ankylosing, Spondylarthropathies, Sacroiliitis, Arthritis, Psoriatic
- Being tested
- Physiotherapy follow-up
- Keywords
- Physiotherapy, Outpatient clinic
- Medical subject headings
- Spondylarthritis, Spondylitis, Ankylosing, Spondylarthropathies, Sacroiliitis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy follow-upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy follow-up | Experimental | Consultation at Physiotherapy-led Outpatient Clinic every 4 month. Receives: Other: Physiotherapy follow-up |
| Usual care | No intervention | Consultation every 4 months, twice a year by rheumatologist as usual, once a year by nurse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leeds Patient Satisfaction Questionnaire (LSQ)
Measured: 8 months
Secondary outcomes (3)
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Measured: 8 months
Bath Ankylosing Spondylitis Functional Index (BASFI)
Measured: 8 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpondylarthritisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Møre og Romsdal HF
- Responsible party
- Sponsor
- Investigators
- Ann-Katrin Stensdotter, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098694
- Sponsor's protocol ID
- 2013/1520 (REK)
- Status last verified
- Jun 2020
- First submitted
- 25 Mar 2014
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29573538
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis
- ClinicalTrials.gov ID
- NCT02098694
- Acronym / sponsor ID
- 2013/1520 (REK)
- Conditions
- Spondylarthritis, Spondylitis, Ankylosing, Spondylarthropathies, Sacroiliitis, Arthritis, Psoriatic
- Keywords
- Physiotherapy, Outpatient clinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Møre og Romsdal HF
- Study start
- Jun 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy follow-up | Experimental | Other: Physiotherapy follow-upConsultation at Physiotherapy-led Outpatient Clinic every 4 month. |
| Usual care | No intervention | –Consultation every 4 months, twice a year by rheumatologist as usual, once a year by nurse. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- confirmed diagnosis spondyloarthritis, ankylosing spondylitis, spondylarthropathy, juvenile ankylosing spondylitis, psoriatic arthritis with affection of the spine
- age between 18 and 45 (born 1969 - 1996)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy follow-upPhysiotherapy 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. | Other | Physiotherapy follow-up |
Primary outcome
Leeds Patient Satisfaction Questionnaire (LSQ)
Time frame: 8 months
3 secondary outcomes
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: 8 months
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: 8 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Results publication: PubMed 29573538Holoyen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann-Katrin Stensdotter, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy follow-up in people with Spondylarthritis and Spondylitis, Ankylosing, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leeds Patient Satisfaction Questionnaire (LSQ) (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02098694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.