Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-27 @ 1:35 PM
Study NCT ID:
NCT05277259
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2022-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effects of Conventional Physical Therapy, Kinesio Taping and ESWT in Upper Trapezius MPS.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'at baseline (before the treatment)', 'description': "patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome."}, {'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '2 weeks after baseline (at the end of treatment)', 'description': "patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome"}, {'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '6 weeks after baseline (one month after the end of treatment)', 'description': "patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome"}, {'measure': 'Neck Disability Index (NDI)', 'timeFrame': 'at baseline (before the treatment)', 'description': "a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The total score ranges from 0 (no disability) to 50 (total disability)."}, {'measure': 'Neck Disability Index (NDI)', 'timeFrame': '2 weeks after baseline (at the end of treatment)', 'description': "a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The total score ranges from 0 (no disability) to 50 (total disability)."}, {'measure': 'Neck Disability Index (NDI)', 'timeFrame': '6 weeks after baseline (one month after the end of treatment)', 'description': "a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The total score ranges from 0 (no disability) to 50 (total disability)."}], 'secondaryOutcomes': [{'measure': 'Measurement of Cervical range of motion (Cervikal ROM)', 'timeFrame': 'at baseline (before the treatment)', 'description': 'Measuring cervical lateral flexion and cervical extension with a manual goniometer.'}, {'measure': 'Measurement of Cervical range of motion (Cervikal ROM)', 'timeFrame': '2 weeks after baseline (at the end of treatment).', 'description': 'Measuring cervical lateral flexion and cervical extension with a manual goniometer.'}, {'measure': 'Measurement of Cervical range of motion (Cervikal ROM)', 'timeFrame': '6 weeks after baseline (one month after the end of treatment)', 'description': 'Measuring cervical lateral flexion and cervical extension with a manual goniometer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trapezius Muscle Strain']}, 'descriptionModule': {'briefSummary': 'There is no study in the literature comparing both kinesiotaping and Extracorporeal Shock Wave Therapy (ESWT) with conventional physical therapy in upper trapezius myofascial pain syndrome. In this study, we aimed to make this comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of at least 1 active trigger point in the upper trapezius muscle, exacerbation of pain when this point(s) is pressed, painful limitation of cervical lateral flexion and extension.\n\nExclusion Criteria:\n\n* Having a history of spine and upper extremity surgery, neuromuscular disease, active rheumatologic disease, active infection, malignancy, having previously applied ESWT or Kinesio Taping to the back and neck region.'}, 'identificationModule': {'nctId': 'NCT05277259', 'briefTitle': 'Comparative Effects of Conventional Physical Therapy, Kinesio Taping and ESWT in Upper Trapezius MPS.', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Comparative Effects of Conventional Physical Therapy, Kinesio Taping and Extracorporeal Shock Wave Therapies in Upper Trapezius Myofascial Pain Syndrome.', 'orgStudyIdInfo': {'id': 'van yyü university'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Extracorporeal Shock Wave Therapy', 'description': 'Extracorporeal shock wave therapy (ESWT) is a noninvasive treatment that involves delivery of shock waves to injured soft tissue to reduce pain and promote healing.', 'interventionNames': ['Device: Extracorporeal Shock Wave Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Kinesiotaping', 'description': 'The Kinesiotaping method is a therapeutic taping technique which alleviates pain.', 'interventionNames': ['Other: Kinesiotaping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Physical Therapy', 'description': 'Hotpack, therapeutic ultrasound and tens applications.', 'interventionNames': ['Other: Conventional Physical Therapy']}], 'interventions': [{'name': 'Extracorporeal Shock Wave Therapy', 'type': 'DEVICE', 'description': "Device named 'Elettronica Pagani,Italy' and will be used with radial probe.", 'armGroupLabels': ['Extracorporeal Shock Wave Therapy']}, {'name': 'Kinesiotaping', 'type': 'OTHER', 'description': 'Elastic band to be used to stretch the upper trapezius muscle in the desired direction.', 'armGroupLabels': ['Kinesiotaping']}, {'name': 'Conventional Physical Therapy', 'type': 'OTHER', 'description': 'Conventional physical therapy will be consisted of hotpack, therapeutic ultrasound and tens applications.', 'armGroupLabels': ['Conventional Physical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Van', 'country': 'Turkey (Türkiye)', 'facility': 'Yuzuncu Yil University', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}], 'overallOfficials': [{'name': 'Volkan Şah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yüzüncü Yıl Üniversitesi Tıp Fakültesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Volkan Şah', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}