Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-27 @ 4:32 PM
Study NCT ID:
NCT02098694
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2014-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D058566', 'term': 'Sacroiliitis'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-04', 'studyFirstSubmitDate': '2014-03-25', 'studyFirstSubmitQcDate': '2014-03-25', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leeds Patient Satisfaction Questionnaire (LSQ)', 'timeFrame': '8 months'}], 'secondaryOutcomes': [{'measure': 'Bath Ankylosing Spondylitis Metrology Index (BASMI)', 'timeFrame': '8 months'}, {'measure': 'Bath Ankylosing Spondylitis Functional Index (BASFI)', 'timeFrame': '8 months'}, {'measure': 'Ankylosing Spondylitis Disease Activity Score (ASDAS)', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physiotherapy', 'Outpatient clinic'], 'conditions': ['Spondylarthritis', 'Spondylitis, Ankylosing', 'Spondylarthropathies', 'Sacroiliitis', 'Arthritis, Psoriatic']}, 'referencesModule': {'references': [{'pmid': '29573538', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed diagnosis spondyloarthritis, ankylosing spondylitis, spondylarthropathy, juvenile ankylosing spondylitis, psoriatic arthritis with affection of the spine\n* age between 18 and 45 (born 1969 - 1996)\n\nExclusion Criteria:\n\n* also diagnosed with potentially functionally impairing neuromuscular, neurological or muscular disorders\n* insufficient Norwegian language skills\n* cognitive impairment\n* no sign of inflammation or bone erosions in the sacroiliac joints or in the spine on imaging'}, 'identificationModule': {'nctId': 'NCT02098694', 'briefTitle': 'Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis', 'orgStudyIdInfo': {'id': '2013/1520 (REK)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physiotherapy follow-up', 'description': 'Consultation at Physiotherapy-led Outpatient Clinic every 4 month.', 'interventionNames': ['Other: Physiotherapy follow-up']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Consultation every 4 months, twice a year by rheumatologist as usual, once a year by nurse.'}], 'interventions': [{'name': 'Physiotherapy follow-up', 'type': 'OTHER', 'description': 'Physiotherapy consultation every 4 months containing assessment of the spine and its mobility, including axial joints, assessment of the patients activity profile.\n\nInstruction in home-exercises and recommendations for optimization of activity profile. Information regarding the disease and the importance of physical activity and exercise.', 'armGroupLabels': ['Physiotherapy follow-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6026', 'city': 'Ålesund', 'country': 'Norway', 'facility': 'Department of Rheumatology, Ålesund hospital', 'geoPoint': {'lat': 62.47225, 'lon': 6.15492}}], 'overallOfficials': [{'name': 'Ann-Katrin Stensdotter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Møre og Romsdal HF', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}