Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-22 @ 2:02 PM
Study NCT ID:
NCT02964156
Status:
COMPLETED
Last Update Posted:
2016-11-16
First Post:
2013-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Thin Customized Insole in RA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-10', 'studyFirstSubmitDate': '2013-12-23', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity measured using Visual Analog Scale (VAS)', 'timeFrame': 'Change between test situation A and B (or B and A). A: Walking test using insoles. B. Walking test not using insoles. There is a 20 minute break between the two situations.', 'description': 'Pain is measured using Visual Analog Scale (VAS)'}, {'measure': 'Walking ability measured using the 6-minute walking test', 'timeFrame': 'Change between test situation A and B (or B and A). A: Walking test using insoles. B. Walking test not using insoles. There is a 20 minute break between the two situations.', 'description': 'Walking ability is measured using the 6-minute walking test'}], 'secondaryOutcomes': [{'measure': 'perceived exertion measured using Borg CR10 scale', 'timeFrame': 'Change between test situation A and B (or B and A). A: Walking test using insoles. B. Walking test not using insoles. There is a 20 minute break between the two situations.', 'description': 'Perceived exertion is measured using Borg category ratio scale (Borg CR10)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RA', 'Insole', 'Forefoot', 'Walking Ability', 'Pain'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': '50-90% of patients with RA reports foot problems and the metatarsophalangeal joints of the forefoot are most frequently afflicted. Studies shows that foot problems can influence negatively on the walking function, physical activity and quality of life. Different foot orthoses and insoles are used as an intervention. Studies find that different insoles do have effect on pain, but there are no or minor effect on walking ability. The literature reports a further need for research and indicates the importance of studies on the effects of cost-effective insoles for patients with RA.\n\nCustom-built insoles takes time and are often expensive, and many patients, especially women, do not wear them since they often do not fit the shoes they prefer to wear. In this study, a 4-mm thin, flat insole of a malleable plastic material (CI-Core®) with synthetic textile material on the upper side is customized to provide support for the transverse and longitudinal arches of the foot to reduce pressure on painful joints. The insole is easily customized and ready for use the same day. The purpose of this study was to determine whether this insole can reduce foot pain and increase walking distance in patients with RA and forefoot pain.\n\nAn experimental study was performed on patients with RA and forefoot pain in either one or both feet. The patients walked as fast as they could in 6 minutes (6MWT) with either insoles (situation A) and without insoles (situation B). The order of situation A and B was randomized, and the assessor was blinded for the order of the two situations. Both tests were conducted the same day. After each test round, the patient was asked to register pain in the foot and perceived exertion. A telephone interview was conducted one year after the effect study to examine whether the insoles were still being used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis Rheumatoid Arthritis\n* Foot pain while walking\n* Positive Gaenslens sign in forefoot\n* Native Norwegian speaking\n\nExclusion Criteria:\n\n* Cognitive dysfunction\n* Problems reading\n* Problems in walking due to problems han the foot such as in ankel, knee or hip'}, 'identificationModule': {'nctId': 'NCT02964156', 'briefTitle': 'Effect of a Thin Customized Insole in RA', 'organization': {'class': 'OTHER', 'fullName': 'Revmatismesykehuset AS'}, 'officialTitle': 'Effect of a Thin Customized Insole on Pain and Walking Ability in Rheumatoid Arthritis: A Randomised Study', 'orgStudyIdInfo': {'id': 'Revma nr 6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Walking test using insoles', 'description': 'Supersole', 'interventionNames': ['Other: Supersole']}, {'type': 'EXPERIMENTAL', 'label': 'Walking test not using insoles', 'description': 'no intervention', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'Supersole', 'type': 'OTHER', 'description': 'A 4-mm thin, individually customized insole of a malleable plastic material (CI-Core®) with synthetic textile material on the upper side.', 'armGroupLabels': ['Walking test using insoles']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Walking test not using insoles']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Knut Mikkelsen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Revmatismesykehuset AS, Lillehammer, Norway'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revmatismesykehuset AS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}