Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-04-17 @ 12:20 AM
Study NCT ID:
NCT02651766
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2016-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Cupping Massage in Patients With Chronic Neck Pain - A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2016-01-07', 'studyFirstSubmitQcDate': '2016-01-08', 'lastUpdatePostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '3 weeks', 'description': "100mm Visual Analogue Scale from 0mm 'no pain' to 100mm 'maximal pain'"}], 'secondaryOutcomes': [{'measure': 'Pain on movement (POM)', 'timeFrame': '3 weeks', 'description': "100mm Visual Analogue Scale from 0mm 'no pain' to 100mm 'maximal pain' Intensity rated for 6 movement directions flexion, tension, and rotation"}, {'measure': 'Neck disability index', 'timeFrame': '3 weeks', 'description': 'NDI measures neck pain complaints (Vernon und Mior 1991)'}, {'measure': 'Quality of Life SF-36', 'timeFrame': '3 weeks', 'description': 'the sf-36 is a short form health survey consisting of 8 scales to measure functional health and wellbeing (Bullinger \\& Kirchberger 1998)'}, {'measure': 'mechanical detection threshold MDT', 'timeFrame': '3 weeks', 'description': 'by von Frey filaments to measure perception threshold for light touch (Rolke, Pain, 2006)'}, {'measure': 'vibration detection threshold VDT', 'timeFrame': '3 weeks', 'description': 'with a tuning fork to measure perception threshold for vibration (Rolke, Pain, 2006)'}, {'measure': 'pressure pain threshold PPT', 'timeFrame': '3 weeks', 'description': 'with a pressure gauge algometer to determine threshold for painful pressure (Rolke, Pain, 2006) on the area of maximal neck pain, the adjacent and hand and foot'}, {'measure': 'Adverse events', 'timeFrame': '3 weeks', 'description': 'Number of patients with adverse events'}, {'measure': 'two point discrimination threshold', 'timeFrame': '3 weeks', 'description': 'using a pair of circles, determining the distance necessary between those to perceive them as separate sensations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neck Pain', 'Mechanical/Motor Problems With Neck and Trunk']}, 'referencesModule': {'references': [{'pmid': '28219058', 'type': 'BACKGROUND', 'citation': 'Saha FJ, Schumann S, Cramer H, Hohmann C, Choi KE, Rolke R, Langhorst J, Rampp T, Dobos G, Lauche R. The Effects of Cupping Massage in Patients with Chronic Neck Pain - A Randomised Controlled Trial. Complement Med Res. 2017;24(1):26-32. doi: 10.1159/000454872. Epub 2017 Feb 15.'}, {'pmid': '22964987', 'type': 'RESULT', 'citation': 'Schumann S, Lauche R, Hohmann C, Zirbes T, Dobos G, Saha FJ. [Development of lipoma following a single cupping massage - a case report]. Forsch Komplementmed. 2012;19(4):202-5. doi: 10.1159/000341869. Epub 2012 Aug 20. German.'}, {'type': 'RESULT', 'citation': 'Schumann S, Lauche R, Irmisch G, Hohmann C, Rolke R, Saha F, Cramer H, Choi KE, Langhorst J, Rampp T, Dobos G, Musial F. The effects of 5 sessions of cupping massage on chronic non-specific neck pain: A randomized controlled pilot study. BMC Complementary and Alternative Medicine, 2012, 12 (Supplement 1): 80.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the influence of 5 cupping massage treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group. Before and after the intervention the investigators evaluate the neck pain (VAS), the neck related disability (NDI), pain on movement (POM) and the quality of life (SF36) and safety. To investigate neurophysiological effects of cupping the investigators also measure mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain threshold (PPT) and the two point discrimination threshold at pain related and control areas.\n\nThe treatment group receives 5 cupping treatments over a period of 3 weeks.', 'detailedDescription': 'see above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 75\n* permanent neck pain for at least three months in a row\n* a minimum of 40mm of neck pain on a 100mm visual analogue scale (VAS)\n\nExclusion Criteria:\n\n* neck pain caused by trauma, inflammatory or malignant disease, by congenital malformation of the spine or if pain was accompanied by radicular symptoms such as radiating pain, paresis, prickling or tingling.\n* invasive treatments within the last 4 weeks, surgery to the spine within the last year, corticosteroid or opioid treatment.\n* serious acute or chronic organic disease such as diabetes or cancer, mental disorders, pregnancy, and haemorrhagic tendency or anticoagulation treatment.\n* non steroidal pain medication and physiotherapy were allowed if the treatment regimen was not altered for four weeks before and continued during the study.'}, 'identificationModule': {'nctId': 'NCT02651766', 'acronym': 'SKM', 'briefTitle': 'The Effects of Cupping Massage in Patients With Chronic Neck Pain - A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'Randomised Controlled Trial on the Influence of Cupping Massage on Pain Intensity and Sensory Mechanical and Pain Thresholds in Patients With Chronic Non Specific Neck Pain', 'orgStudyIdInfo': {'id': '09-3987-BO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Waiting List control group', 'description': 'No treatment within the study period, were allowed to continue physiotherapy and medication. Were offered the treatment after finishing the study'}, {'type': 'EXPERIMENTAL', 'label': 'Cupping massage treatment', 'description': 'Received the 5 cupping treatments, application twice a week on the upper back and neck', 'interventionNames': ['Procedure: Cupping massage']}], 'interventions': [{'name': 'Cupping massage', 'type': 'PROCEDURE', 'otherNames': ['Moving cupping treatment'], 'description': 'Using suction on the skin by means of glass cups, and moving the cups after applying massage oil on the skin', 'armGroupLabels': ['Cupping massage treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45276', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Knappschaftskrankenhaus', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'GUstav Dobos, Prof MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Duisburg-Essen, Chair of Complementary and Integrative Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Romy Lauche', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}