Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-28 @ 6:53 PM
Study NCT ID:
NCT03867604
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2019-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Fascial Release Injection for Myofascial Pain Syndrome in 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': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2019-01-21', 'studyFirstSubmitQcDate': '2019-03-06', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper back or shoulder pain', 'timeFrame': 'Change from baseline VAS at 1 week', 'description': 'visual analogue scale(VAS), range 0-10, the higher the worse pain'}, {'measure': 'Upper back or shoulder pain', 'timeFrame': 'Change from baseline VAS at 4 week', 'description': 'visual analogue scale(VAS), range 0-10, the higher the worse pain'}, {'measure': 'Upper back or shoulder pain', 'timeFrame': 'Change from baseline VAS at 12 week', 'description': 'visual analogue scale(VAS), range 0-10, the higher the worse pain'}], 'secondaryOutcomes': [{'measure': 'Function', 'timeFrame': 'Change from baseline SPADI at 1 week', 'description': 'Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse'}, {'measure': 'Function', 'timeFrame': 'Change from baseline SPADI at 4 week', 'description': 'Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse'}, {'measure': 'Function', 'timeFrame': 'Change from baseline SPADI at 12 week', 'description': 'Shoulder Pain and Disability Index (SPADI), range 0-130, the higher the worse'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myofascial Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '38320240', 'type': 'DERIVED', 'citation': 'Hsu CY, Hsu T, Lin YN, Cheng YH. Additional Effect of Interfascial Hydrodissection With Dextrose on Shoulder and Neck Function in Patients With Myofascial Pain Syndrome: A Randomized Control Trial. Am J Phys Med Rehabil. 2024 Sep 1;103(9):827-834. doi: 10.1097/PHM.0000000000002442. Epub 2024 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'Patients with myofascial pain syndrome at upper trapezius will be randomized into 2 groups, fascial injection group and subcutaneous control injection group. Pain condition pain, range of motion and function will be evaluated in 1 week, 4 weeks and 12 weeks after injection.', 'detailedDescription': 'Myofascial pain syndrome(MPS) is characterized by a trigger point with a hyperirritable nodule and taut band of muscle or fascia. MPS was usually treated by dry needling or met needing, local anesthetics injection, to the trigger point. According to recent researches, dry and wet needling to affected muscle are effectiveness for short term and medium term pain relief. Although some researches indicated an increased viscosity at fascial layer in MPS and there are few studies of manipulation for fascial release. There is not study of injective fascial release.\n\nInvestigators will include 40 patients with myofascial pain syndrome at upper trapezius. Participants will be randomized into 2 groups, fascia injection group and subcutaneous control injection group. Investigators will use algometer to measure pain threshold and peak pressure, measure the range of motion of neck and shoulder and assess the neck and shoulder function by questionnaire. The examination will be done before injection, immediately after injection, 1 week, 4 weeks and 12 weeks after injection.\n\nTo our hypothesis, investigators suggest focal anesthetics injection could decrease the fascial viscosity and improved pain and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-70 years old\n* diagnosed as a myofascial pain syndrome at upper trapezium muscle\n* trigger point\n* taut band\n* refer pain while taut band irritation\n\nExclusion Criteria:\n\n* Cognitive impairment.\n* Post operation at neck and shoulder.\n* Nerve compression at cervical region.\n* Could not receive injection therapy, history of fainting during needling'}, 'identificationModule': {'nctId': 'NCT03867604', 'briefTitle': 'Ultrasound-guided Fascial Release Injection for Myofascial Pain Syndrome in the Upper Trapezius Muscle', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'Ultrasound-guided Fascial Release Injection for Myofascial Pain Syndrome in the Upper Trapezius Muscle: A Pilot Study', 'orgStudyIdInfo': {'id': 'N201811013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham injection', 'description': 'Subcutaneous injection at upper trapezium muscle level', 'interventionNames': ['Procedure: Sham injection']}, {'type': 'EXPERIMENTAL', 'label': 'Fascia injection', 'description': 'Fascia injection, below upper trapezium muscle', 'interventionNames': ['Procedure: Fascia injection']}], 'interventions': [{'name': 'Sham injection', 'type': 'PROCEDURE', 'description': 'Injection to the subcutaneous layer at upper trapezium level', 'armGroupLabels': ['Sham injection']}, {'name': 'Fascia injection', 'type': 'PROCEDURE', 'description': 'Injection to the fascia below upper trapezium muscle', 'armGroupLabels': ['Fascia injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei medical university', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yu-Hsuan Cheng, Cheng', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taipei Medical University, Taiwan, R.O.C.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}