Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 7:25 PM
Study NCT ID:
NCT04519333
Status:
COMPLETED
Last Update Posted:
2020-08-19
First Post:
2020-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesotherapy Versus Systemic Therapy in Treating Neck Pain Related to Herniated Disc
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain intensity', 'timeFrame': '0-24 hours', 'description': 'we defined as the delta value of Vizuel Analog Score(points between 0-10,the most severe pain 10 points,0 points no pain) scores with different time intervals. We calculated delta values by subtracting the VAS scores at 60th and 120th minutes, and 24th hours from the VAS score on admission.'}, {'measure': 'Adverse effect', 'timeFrame': '0-1 week', 'description': 'we have defined as the presence of hypotension, dizziness, nausea, vomiting, diarrhea, edema, localized infections, pruritus, bruising or swelling at the injection sites in the mesotherapy group; and presence of dry mouth, hypotension, dizziness, nausea, vomiting, diarrhea, dyspepsia, peptic ulceration, peptic ulcer bleeding, urticarial lesion, pruritus in the systemic therapy group. The patients were followed up for one week for presence of adverse effects. We interviewed with the patientsdaily by telephone for adverse effects, and evaluated all the patientswith an ED visit at the end of follow-up period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mesotherapy', 'Neck Pain'], 'conditions': ['Emergencies']}, 'descriptionModule': {'briefSummary': 'Introduction: Neck pain is a global public health concern, that ranked 4th highest health condition in terms of disability as measured by years lived with disability. The aim of this study is to compare the efficiency of one-session mesotherapy application with systemic therapy in treating neck pain related to cervical disk herniation.\n\nMethods: This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with neck pain related to cervical disc herniation. A mixture of thiocolchicoside, lidocaine and tenoxicamwas administered via mesotherapy in one group, and intravenous administration of dexketoprofen was applied to the other group. We compared the changes in pain intensity at 60thminute, 120thminute and 24th hours after treatment using Visual Analogue Scale (VAS),and adverse effects of the treatment methods among the study groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older age\n* Admission to Emergency Department (ED) with acute cervical pain related to cervical disk herniation.\n\nExclusion Criteria:\n\n* Taking analgesic drugs before admission\n* Having VAS score of lower than 4 on admission\n* Having diabetes mellitus\n* Body mass index\\>30 kg/m2\n* Pregnancy\n* Lactation\n* Having active bleeding or bleeding disorder\n* Having active or recurrent gastrointestinal hemorrhage or ulcer, or history of these conditions\n* Having a serious or life-threatening condition (stroke, intracranial hemorrhage, heart attack, cardiac tamponade, pneumothorax, hemothorax, flail chest, etc.).'}, 'identificationModule': {'nctId': 'NCT04519333', 'briefTitle': 'Mesotherapy Versus Systemic Therapy in Treating Neck Pain Related to Herniated Disc', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Intradermal Mesotherapy Versus Systemic Therapy in Treating Neck Pain to Cervical Disc Herniation: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'AtaturkU0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Compare to sistemic treatment and mesotherapy.', 'description': 'This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with neck pain related to cervical disc herniation', 'interventionNames': ['Procedure: drug(intradermal injection)']}], 'interventions': [{'name': 'drug(intradermal injection)', 'type': 'PROCEDURE', 'description': 'The mesotherapy was performed by an experienced and trained physician using a disposable 4 mm and 6 mm long, 30 Gauge needles. Initially, a pharmacological mixture of 1 cc (2 mg) thiocolchicoside, 1 cc (16.2 mg) lidocaine and 1 cc (5 mg) tenoxicam was prepared for each treatment session, and 0.1-0.2 cc of this mixture was applied to each injection point with a depth of 1-3 mm using point by point intradermal method without causing papules.\n\nIn the systemic therapy group, we applied a 50 mg dexketoprofen (Revafen, Haver Pharma Pharmaceutical Co., Turkey) in 100 cc isotonic solution intravenously for 5 minutes.', 'armGroupLabels': ['Compare to sistemic treatment and mesotherapy.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Abdullah Osman KOCAK', 'investigatorAffiliation': 'Ataturk University'}}}}