Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 10:48 PM
Study NCT ID:
NCT01635634
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2012-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cupping in Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079742', 'term': 'Cupping Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2012-07-03', 'studyFirstSubmitQcDate': '2012-07-06', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'Day 18', 'description': 'Pain on a 100mm visual analog scale'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'Day 200', 'description': 'Pain intensity measured on a 100mm visual analog scale'}, {'measure': 'Fatigue', 'timeFrame': 'Day 18', 'description': 'Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995'}, {'measure': 'Fatigue', 'timeFrame': 'Day 200', 'description': 'Fatigue measured by the Multidimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke et al., 1995'}, {'measure': 'Sleep Quality', 'timeFrame': 'Day 18', 'description': 'measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)'}, {'measure': 'Sleep Quality', 'timeFrame': 'Day 200', 'description': 'measured by the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al. 1989)'}, {'measure': 'Quality of life', 'timeFrame': 'Day 18', 'description': 'measured by the SF-36 (Bullinger \\& Kirchberger, 1998)'}, {'measure': 'Quality of life', 'timeFrame': 'Day 200', 'description': 'measured by the SF-36 (Bullinger \\& Kirchberger, 1998)'}, {'measure': 'Medication', 'timeFrame': 'Day 18', 'description': 'measured by a medication log, daily entering of used drugs'}, {'measure': 'adverse events', 'timeFrame': 'Day 18', 'description': 'all adverse events'}, {'measure': 'Pressure pain sensitivity', 'timeFrame': 'Day 18', 'description': 'using an electronic algometer (Somedic, Sweden) to determine threshold of pain perception on predefined muscles'}, {'measure': 'Disability', 'timeFrame': 'Day 18', 'description': 'measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)'}, {'measure': 'Disability', 'timeFrame': 'Day 200', 'description': 'measured by the FI (fibromyalgia impact questionnaire) (Offenbaecher, Waltz, Schoeps , 2000)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Cupping'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '27853272', 'type': 'BACKGROUND', 'citation': 'Lauche R, Spitzer J, Schwahn B, Ostermann T, Bernardy K, Cramer H, Dobos G, Langhorst J. Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial. Sci Rep. 2016 Nov 17;6:37316. doi: 10.1038/srep37316.'}], 'seeAlsoLinks': [{'url': 'http://www.kliniken-essen-mitte.de/leistung/fachabteilungen/naturheilkunde-u-integrative-medizin/home.html', 'label': 'Homepage of the Clinic'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized controlled study is to determine the effectiveness of cupping in patients with fibromyalgia compared to sham cupping.', 'detailedDescription': 'see above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* FMS diagnosis according to AWMF Guidelines,\n* necessary documents: medical records\n* Pain intensity \\> 45mm VAS\n* Participation in cupping twice weekly on appointment\n\nExclusion Criteria:\n\n* pregnancy\n* other study participation\n* pain due to other rheumatic disease\n* major psychiatric disorder\n* substance abuse\n* severe somatic disorder (cancer)\n* injections, acupuncture, neural therapy within the past 3 months'}, 'identificationModule': {'nctId': 'NCT01635634', 'acronym': 'CuFib', 'briefTitle': 'Cupping in Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'Randomized Controlled Pilot Trial: The Effectiveness of Cupping in Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': 'CuFib'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham Cupping', 'description': 'Dry Cupping Therapy 5 serial treatments twice weekly 4-8 cups at the upper and lower back', 'interventionNames': ['Other: Cupping therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Cupping Therapy', 'description': 'Dry Cupping 5 serial treatments twice weekly 4-8 cups at the upper and lower back', 'interventionNames': ['Other: Cupping therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Wait list', 'description': 'Wait list control no specific intervention for 3 weeks study period'}], 'interventions': [{'name': 'Cupping therapy', 'type': 'OTHER', 'description': 'Cups are placed at the skin; local suction is created on the skin; it mobilizes blood flow; the suction is created by a mechanical device (Pneumatron, Pneumed, Germany)', 'armGroupLabels': ['Cupping Therapy', 'Sham Cupping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45276', 'city': 'Essen', 'country': 'Germany', 'facility': 'Klinik für Naturheilkunde', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Jost Langhorst, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Duisburg-Essen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Jost Langhorst', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}