Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT06329960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dorsal Scapular Nerve Injection Combined With Muscle Needle Release
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue scale (VAS)', 'timeFrame': 'before treatment, as well as 1, 3, 6 months post treatment', 'description': 'VAS is the most common tool to evaluate discomfort for patients with peripheral entrapment neuropathies, with scores ranging from 0 (no pain) to 10 (intolerant pain)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dorsal Scapular Nerve Entrapment']}, 'referencesModule': {'references': [{'pmid': '36980446', 'type': 'BACKGROUND', 'citation': 'Lam KHS, Wu YT, Reeves KD, Galluccio F, Allam AE, Peng PWH. Ultrasound-Guided Interventions for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analyses. Diagnostics (Basel). 2023 Mar 16;13(6):1138. doi: 10.3390/diagnostics13061138.'}, {'pmid': '28928496', 'type': 'BACKGROUND', 'citation': 'Muir B. Dorsal scapular nerve neuropathy: a narrative review of the literature. J Can Chiropr Assoc. 2017 Aug;61(2):128-144.'}]}, 'descriptionModule': {'briefSummary': 'Ultrasound-guided perineural injection (PIT) of 5% dextrose (D5W) hydrodissection has been widely used in the treatment of peripheral entrapment neuropathies. However, there are few studies investigating the efficacy of PIT using D5W HD for dorsal scapular nerve (DSN) entrapment. Generally, the DSN entrapment causes the stiffness of the major and minor rhomboideus(2). In clinical practice, the investigators observed that ultrasound-guided PIT using D5W HD combined with needle release of major and minor rhomboideus significantly relieved the pain of scapular region. Therefore, the investigators aimed to evaluate the 6-month efficacy of this procedure for the participants with DSN entrapment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with DSN entrapment confirmed by electrophysiological study;\n* age 18-80 years;\n* patients who were irresponsive to conservative treatment;\n* symptoms persisted for more than 3 months.\n\nExclusion Criteria:\n\n* pregnancy\n* DSN entrapment caused by trauma, surgery or occupying lesions of DSN;\n* concurrent presence of rheumatic immune diseases, hypothyroidism, or diabetes mellitus;\n* C5/6 lumbar radiculopathy;\n* previous history of local injection or surgery for DSN entrapment.'}, 'identificationModule': {'nctId': 'NCT06329960', 'briefTitle': 'Dorsal Scapular Nerve Injection Combined With Muscle Needle Release', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Efficacy of Ultrasound-guided Dorsal Scapular Nerve Injection Combined With Rhomboideus Muscle Needle Release', 'orgStudyIdInfo': {'id': '2024PHB019-001(3)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Ultrasound-guided dorsal scapular nerve injection combined with needle release of major and minor rhomboideus', 'interventionNames': ['Other: Ultrasound-guided injection combined with needle release']}], 'interventions': [{'name': 'Ultrasound-guided injection combined with needle release', 'type': 'OTHER', 'description': 'Ultrasound-guided PIT using D5W HD for dorsal scapular nerve combined with needle release of major and minor rhomboideus', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Jiaan Zhu', 'role': 'CONTACT', 'email': 'canzhujia@126.com'}], 'facility': 'Jiaan Zhu', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jiaan Zhu, PhD', 'role': 'CONTACT', 'email': 'canzhujia@126.com', 'phone': '+86-010-88325378'}], 'overallOfficials': [{'name': 'Jiaan Zhu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman', 'investigatorFullName': 'Zhu Jiaan', 'investigatorAffiliation': "Peking University People's Hospital"}}}}