Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05123105
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2021-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Dry Cupping and Ischemic Compression on the Trigger Point on the Upper Trapezius Muscle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079742', 'term': 'Cupping Therapy'}, {'id': 'D019050', 'term': 'Acupressure'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each person participated in three tests with an interval of approximately one week between them. The following study protocol was followed; (short version)\n\n1. cupping therapy;\n\n \\- a minimum interval of 7 days;\n2. control test;\n\n \\- a minimum interval 7 days;\n3. ischemic compression.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2021-10-23', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain pressure threshold test (PPT)', 'timeFrame': 'changes from baseline in pain pressure threshold at 2 minutes after the session', 'description': 'The trigger points of the upper section of the trapezius on the right and left sides were determined by palpation and were also indicated using a marker. A Wagner FDX 50 Force Gage algometer was applied to the trigger point. The pressure force was increased by 1kg/cm2/s until the patient felt pain, which was the pain pressure threshold (PPT) measured in kg/cm2. The test was performed on both sides. The test was performed twice on each side - before and 2 minutes after the session.'}, {'measure': 'Cervical spine mobility test', 'timeFrame': 'changes from baseline in cervical spine mobility at 2 minutes after the session', 'description': "Each examination began in a sitting position with a cervical spine mobility test. The following bone points were marked on the participants' skin using a marker: spinous process of the 7th cervical vertebra, external occipital protuberance, the top of the chin, the jugular notch of the sternum, the mastoid of the temporal bone, and the acromion process of the scapula. Next, a linear measurement of the range of motion was performed using a tape measure to ascertain the distance between the marked points in the initial position and after the active movement for flexion (forward bending), extension (backward bending), lateral bending and rotation to both sides, respectively. The mobility was determined by the difference of the two measurements. The test for each movement (i.e. flexion (forward flexion), extension (backward flexion), lateral flexion and both sides rotation) was performed twice - before and 2 minutes after the session."}], 'secondaryOutcomes': [{'measure': 'Height', 'timeFrame': 'Measurements were taken before the first session', 'description': 'Height measured in meters'}, {'measure': 'Weight', 'timeFrame': 'Measurements were taken before the first session', 'description': 'Weight measured in kilograms'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ischemic compression', 'cupping', 'algometer', 'trapezius muscle'], 'conditions': ['Trigger Point Pain, Myofascial']}, 'descriptionModule': {'briefSummary': 'Ischemic compression is considered the fastest and most common method for providing relief in trigger point therapy, whereas cupping therapy is not a method often used for this purpose. The muscle that has a great impact on tension-type headaches and neck pain is the trapezius, whose upper fibres are where the most common trigger point in the back is located.\n\nThe aim of this study was to evaluate and compare the effectiveness of single ischemic compression and single dry cupping therapy on the most common trigger point, on the descending part of the trapezius muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-30\n* student of The Józef Piłsudski University of Physical Education in Warsaw\n* written consent to participate in the study\n\nExclusion Criteria:\n\n* past or current injury to the trapezius.\n* past or current injury of the cervical spine limiting mobility of this segment.\n* broken skin at the examination site.\n* cardiological disease and use of blood pressure medication, histamine medication and analgesics\n* elevated body temperature, illness symptoms and a period of convalescence.\n* a missed anti-Covid procedure before each examination.\n* inability to find trigger points.'}, 'identificationModule': {'nctId': 'NCT05123105', 'briefTitle': 'Effect of Dry Cupping and Ischemic Compression on the Trigger Point on the Upper Trapezius Muscle', 'organization': {'class': 'OTHER', 'fullName': 'Józef Piłsudski University of Physical Education'}, 'officialTitle': 'Effect of Dry Cupping and Ischemic Compression on the Trigger Point on the Upper Trapezius Muscle', 'orgStudyIdInfo': {'id': 'SKE 01-03/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Each person participated in three tests with an interval of approximately one week between them.', 'interventionNames': ['Other: 1) cupping therapy', 'Other: 2) control test (no intervention)', 'Other: 3) ischemic compression']}], 'interventions': [{'name': '1) cupping therapy', 'type': 'OTHER', 'description': 'The participant lay on his front on a couch. The examiner applied a plastic cup on a pre-marked trigger point, suctioned it with a mechanical pump and left it for 2 minutes. This was a stationary application with medium suction force. Therapy was performed on both sides. Measurements were taken before and 2 minutes after the therapy.', 'armGroupLabels': ['Experimental']}, {'name': '2) control test (no intervention)', 'type': 'OTHER', 'description': 'The participant lay on his front on a couch for 4 minutes without any activity and without anyy intervention. Measurements were taken before and after the session.', 'armGroupLabels': ['Experimental']}, {'name': '3) ischemic compression', 'type': 'OTHER', 'description': 'The participant lay on his front on a couch. The researcher applied pressure to a pre-marked trigger point using the thumb for 2 minutes until tissue resistance was felt. This included 60-second compression and after a break of a few seconds, another 60 seconds of compression. Therapies were performed on each side. Measurements were taken before and 2 minutes after the therapy.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00-968', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Józef Piłsudski University of Physical Education in Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Agnieszka Zdrodowska, PH.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Józef Piłsudski University of Physical Education in Warsaw'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Józef Piłsudski University of Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'academic researcher, doctor of science', 'investigatorFullName': 'Agnieszka Zdrodowska', 'investigatorAffiliation': 'Józef Piłsudski University of Physical Education'}}}}