Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT02027792
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2014-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cabbage Leaf Wraps in Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2014-01-03', 'studyFirstSubmitQcDate': '2014-01-03', 'lastUpdatePostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Course of Pain', 'timeFrame': '12 weeks', 'description': 'measured by a diary including pain intensity on a visual analogue scale, medication'}, {'measure': 'Satisfaction', 'timeFrame': '20 weeks', 'description': 'Satisfaction with either treatments'}], 'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '4 weeks', 'description': 'pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)'}], 'secondaryOutcomes': [{'measure': 'knee function (WOMAC)', 'timeFrame': '4 weeks', 'description': 'physical everyday function using the validated WOMAC questionnaire'}, {'measure': 'Quality of Life (SF-36)', 'timeFrame': '4 weeks', 'description': 'health related quality of life with the validated SF-36 questionnaire'}, {'measure': 'self-efficacy (ASES-D)', 'timeFrame': '4 weeks', 'description': 'self-efficacy with the arthritis specific self efficacy scale in German'}, {'measure': 'physical function (30second chair test)', 'timeFrame': '4 weeks', 'description': 'validated test to measure how often patients can stand up from a chair in 30 seconds)'}, {'measure': 'Pressure pain sensitivity', 'timeFrame': '4 weeks', 'description': 'measured by an algometer at predefined areas'}, {'measure': 'Adverse events', 'timeFrame': '4 weeks', 'description': 'Safety measure'}, {'measure': 'knee function (WOMAC)', 'timeFrame': '12 weeks', 'description': 'physical everyday function using the validated WOMAC questionnaire'}, {'measure': 'Quality of Life (SF-36)', 'timeFrame': '12 weeks', 'description': 'health related quality of life with the validated SF-36 questionnaire'}, {'measure': 'self-efficacy (ASES-D)', 'timeFrame': '12 weeks', 'description': 'self-efficacy with the arthritis specific self efficacy scale in German'}, {'measure': 'physical function (30second chair test)', 'timeFrame': '12 weeks', 'description': 'validated test to measure how often patients can stand up from a chair in 30 seconds)'}, {'measure': 'Pressure pain sensitivity', 'timeFrame': '12 weeks', 'description': 'measured by an algometer at predefined areas'}, {'measure': 'Adverse events', 'timeFrame': '12 weeks', 'description': 'Safety measure'}, {'measure': 'Pain intensity', 'timeFrame': '12 weeks', 'description': 'pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Knee']}, 'referencesModule': {'references': [{'pmid': '26889617', 'type': 'RESULT', 'citation': 'Lauche R, Graf N, Cramer H, Al-Abtah J, Dobos G, Saha FJ. Efficacy of Cabbage Leaf Wraps in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized Controlled Trial. Clin J Pain. 2016 Nov;32(11):961-971. doi: 10.1097/AJP.0000000000000352.'}]}, 'descriptionModule': {'briefSummary': 'This randomised controlled trial aims to investigate the efficacy of cabbage leaf cataplasms in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply either cabbage leaf cataplasm or diclofenac gel daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire on pain, disability, quality of life and pressure pain sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* osteoarthritis of the knee, Kellgren Lawrence stadium 2-3\n* at least 50% of days with complaints\n* initial pain intensity 45mm on a 100mm visual analoge scale\n\nExclusion Criteria:\n\n* medication with corticoids or immunsupressing drugs\n* secondary arthritis/arthrosis\n* operation to the knee within 12 months prior\n* injection within 4 weeks (cortison) or 6 months prior (hyaluronic acid)\n* severe comorbidities (liver, kidney, asthma, psychiatric disorders etc.)\n* participation in other studies\n* pregnancy, breastfeeding'}, 'identificationModule': {'nctId': 'NCT02027792', 'acronym': 'KoGon', 'briefTitle': 'Cabbage Leaf Wraps in Osteoarthritis of the Knee', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'Randomised Controlled Trial on the Efficacy of Cabbage Leaf Wraps in Symptomatic Primary Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': '13-5581 KoGon'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cabbage leaf wraps', 'description': 'Daily application of cabbage leaf wraps over night, 4 weeks application', 'interventionNames': ['Other: Cabbage leave wraps']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diclofenac gel', 'description': 'daily application of diclofenac gel 4 weeks application', 'interventionNames': ['Drug: Diclofenac Gel']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'no specific intervention'}], 'interventions': [{'name': 'Cabbage leave wraps', 'type': 'OTHER', 'armGroupLabels': ['Cabbage leaf wraps']}, {'name': 'Diclofenac Gel', 'type': 'DRUG', 'armGroupLabels': ['Diclofenac gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45276', 'city': 'Essen', 'country': 'Germany', 'facility': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Romy Lauche', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}