Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-31 @ 9:00 AM
Study NCT ID:
NCT06610032
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2024-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mesotherapy and Intra-articular Steroid Injection in Shoulder Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057748', 'term': 'Mesotherapy'}, {'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D007279', 'term': 'Injections, Subcutaneous'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-09-20', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS (Visual Analouge Scale)', 'timeFrame': 'Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.', 'description': 'Pain Severity evaluation ((0 (no pain)-10 (unbearable pain))'}, {'measure': "Shoulder Disability Questionnaire' (OSS) form", 'timeFrame': 'Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.', 'description': 'Functional Disability evaluation (0-100)'}, {'measure': 'Goniometric shoulder range of motion', 'timeFrame': 'Patients will be evaluated before treatment, 30 minutes and 4 weeks after the injections.', 'description': 'shoulder range of motion evaluation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shoulder', 'Mesotherapy', 'Pain', 'Steroid Injection'], 'conditions': ['Chronic Shoulder Pain']}, 'referencesModule': {'references': [{'pmid': '22654954', 'type': 'BACKGROUND', 'citation': 'Mammucari M, Gatti A, Maggiori S, Sabato AF. Role of mesotherapy in musculoskeletal pain: opinions from the italian society of mesotherapy. Evid Based Complement Alternat Med. 2012;2012:436959. doi: 10.1155/2012/436959. Epub 2012 May 13.'}, {'pmid': '33764479', 'type': 'BACKGROUND', 'citation': 'Faetani L, Ghizzoni D, Ammendolia A, Costantino C. Safety and efficacy of mesotherapy in musculoskeletal disorders: A systematic review of randomized controlled trials with meta-analysis. J Rehabil Med. 2021 Apr 27;53(4):jrm00182. doi: 10.2340/16501977-2817.'}]}, 'descriptionModule': {'briefSummary': 'Patients with chronic shoulder pain will be divided randomly into mesotherapy and intra-articular steroid injection groups. Pain severity, range of motion and functional impairment will evaluated before treatment, 30 minutes and 4 weeks after the injections.', 'detailedDescription': 'The study will include 84 patients aged 18-75 who applied to physical medicine and rehabilitation out-patient clinic with chronic shoulder pain between May and July 2024. Patients will be randomly divided into two groups: a mesotherapy group and steroid injection group, using the closed-envelope method. In the first group, a total of 3 sessions of mesotherapy are applied to the shoulder areas of the patients, 7 days apart. A single-session intra-articular 20 mg triamcinolone hexacetonide injection will be administered for patients in group 2. Pain severity, range of motion and functional impairment will evaluated before treatment, 30 minutes and 4 weeks after the injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages 18-75\n2. Having shoulder pain for 6 months\n3. VAS (Visual Analog Scale) \\> 4\n4. Patients who can receive verbal instructions and do not have cognitive deficits\n\nExclusion Criteria:\n\n1. Physical therapy applied to the shoulder area in the last 3 months\n2. Having had a shoulder joint injection in the last 3 months\n3. History of previous upper extremity surgery\n4. History of drug allergy\n5. Use of anticoagulant drugs (warfarin, low molecular weight heparin), patients with coagulation disorder\n6. History of malignancy\n7. Psychiatric illness\n8. A rheumatological diagnosis such as Polymyalgia Rheumatica, Rheumatoid Arthritis, Ankylosing Spondylitis\n9. Kidney failure\n10. Liver disease\n11. Heart failure\n12. Pregnancy\n13. Presence of infection, wound, allergy, burn-like lesions in the application area'}, 'identificationModule': {'nctId': 'NCT06610032', 'acronym': 'Mesotherapy', 'briefTitle': 'The Effect of Mesotherapy and Intra-articular Steroid Injection in Shoulder Pain', 'organization': {'class': 'OTHER', 'fullName': 'Haydarpasa Numune Training and Research Hospital'}, 'officialTitle': 'The Comparison O the Efficacy of Mesotherapy and Intra-articular Steroid Injection in Patients with Chronic Shoulder Pain', 'orgStudyIdInfo': {'id': 'IMU-GETAT-EK 05/27.03.2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mesotherapy', 'description': 'A total of 3 sessions of mesotherapy will be applied to the shoulder area, 7 days apart.', 'interventionNames': ['Procedure: Mesotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Steroid', 'description': 'A single-session intra-articular 20 mg triamcinolone hexacetonide injection will be administered.', 'interventionNames': ['Procedure: Intra-articular steroid injection']}], 'interventions': [{'name': 'Mesotherapy', 'type': 'PROCEDURE', 'otherNames': ['Intra-articular steroid injection'], 'description': 'A total of 3 sessions of mesotherapy will be applied to the shoulder area of the patients, 7 days apart in group 1.', 'armGroupLabels': ['Mesotherapy']}, {'name': 'Intra-articular steroid injection', 'type': 'PROCEDURE', 'otherNames': ['Mesotherapy'], 'description': 'Single session intra-articular 20 mg triamcinolone hexacetonide injection will be applied for patients in group 2.', 'armGroupLabels': ['Steroid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34668', 'city': 'Istanbul', 'state': 'Üsküdar', 'country': 'Turkey (Türkiye)', 'facility': 'Health Science University Haydarpasa Numune Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haydarpasa Numune Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor of Physical Medicine and Rehabilitation', 'investigatorFullName': 'Ecem Pelin Kaymaz', 'investigatorAffiliation': 'Haydarpasa Numune Training and Research Hospital'}}}}