Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
Study NCT ID:
NCT06129006
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Shoulder Anterior Capsular Infiltration Plus Hydrodilatation With Steroid Versus Hyalase in Patients With Frozen Shoulder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2023-11-08', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Shoulder Pain and Disability Index (SPADI)', 'timeFrame': 'baseline and 3 weeks, 3 months, and 12 months after the intervention', 'description': 'The Shoulder Pain and Disability Index (SPADI) will be used to evaluate pain and disability at baseline and 3 weeks, 3 months, and 12 months after the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frozen Shoulder']}, 'referencesModule': {'references': [{'pmid': '33585024', 'type': 'BACKGROUND', 'citation': 'Konarski W, Pobozy T, Hordowicz M, Pobozy K, Domanska J. Current concepts of natural course and in management of frozen shoulder: A clinical overview. Orthop Rev (Pavia). 2021 Jan 28;12(4):8832. doi: 10.4081/or.2020.8832. eCollection 2020 Dec 31.'}, {'pmid': '37143964', 'type': 'BACKGROUND', 'citation': 'Sam N, Yusuf I, Idris I, Adnan E, Haryadi RD, Hamid F, Usman MA, Johan MP, Zainuddin AA. A Case Series: Effect of Comorbidities on the Outcomes of Prolotherapy Injection for Frozen Shoulder Patients. Int Med Case Rep J. 2023 Apr 28;16:257-263. doi: 10.2147/IMCRJ.S407723. eCollection 2023.'}, {'pmid': '31475043', 'type': 'BACKGROUND', 'citation': 'Cho CH, Bae KC, Kim DH. Treatment Strategy for Frozen Shoulder. Clin Orthop Surg. 2019 Sep;11(3):249-257. doi: 10.4055/cios.2019.11.3.249. Epub 2019 Aug 12.'}, {'pmid': '35936858', 'type': 'BACKGROUND', 'citation': 'Prasetia R, Albana R, Herman H, Lesmana R, Chernchujit B, Rasyid HN. Ultrasound-Guided Suprascapular Nerve Block at Spinoglenoid Notch and Glenohumeral Joint Hydrodilation. Arthrosc Tech. 2022 Jun 14;11(7):e1233-e1238. doi: 10.1016/j.eats.2022.03.009. eCollection 2022 Jul.'}, {'pmid': '35699461', 'type': 'BACKGROUND', 'citation': 'Albana R, Prasetia R, Primadhi A, Rahim AH, Ismiarto YD, Rasyid HN. The role of suprascapular nerve block in hydrodilatation for frozen shoulder. SICOT J. 2022;8:25. doi: 10.1051/sicotj/2022026. Epub 2022 Jun 14.'}, {'pmid': '3402544', 'type': 'BACKGROUND', 'citation': 'Cravioto A, Reyes RE, Ortega R, Fernandez G, Hernandez R, Lopez D. Prospective study of diarrhoeal disease in a cohort of rural Mexican children: incidence and isolated pathogens during the first two years of life. Epidemiol Infect. 1988 Aug;101(1):123-34. doi: 10.1017/s0950268800029289.'}, {'pmid': '34399045', 'type': 'BACKGROUND', 'citation': 'Lee JH, Choi EJ, Han SC, Chung HS, Kwon MJ, Jayaram P, Lee W, Lee MY. Therapeutic efficacy of low-dose steroid combined with hyaluronidase in ultrasonography-guided intra-articular injections into the shoulder for adhesive capsulitis. Ultrasonography. 2021 Oct;40(4):555-564. doi: 10.14366/usg.20199. Epub 2021 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'To compare ultrasound-guided shoulder anterior capsular infiltration plus hydrodilatation with a steroid versus hyalase in patients with frozen shoulders', 'detailedDescription': 'Frozen shoulder (FS) is a self-limiting pathology of the shoulder joint causing restriction in both the active and passive range of movements associated with pain (Konarski et al., 2020).\n\nA frozen shoulder is a common condition causing severe pain and a reduced range of motion in the shoulder. It can result in detrimental effects on quality of life and the ability to perform activities of daily living (ADLs). It affects 2% to 5% of the global population and is more common in diabetic patients. There are a variety of treatment options available for patients with frozen shoulders as part of the management ladder of interventions. FS may persist for more than three years or may never resolve (Sam et al., 2023).\n\nConservative management includes physiotherapy, NSAIDs, Hydrodilatation (HD), intra-articular steroids, manipulation under anesthesia, and arthroscopic, or open capsular release. Distension of the shoulder capsule with normal saline and steroid infusion has been suggested to benefit by changing the biochemical properties of the capsule in FS (Cho et al., 2019).\n\nHydrodilatation of the shoulder joint capsule was a novel treatment to alleviate the pain of the affected shoulder. The procedure may be given with or without an adjuvant corticosteroid. Hydrodilatation, using saline and a corticosteroid, was superior in short-term pain reduction and range of motion improvement compared to management using only physiotherapy and corticosteroid injection in patients treated for frozen shoulder (Prasetia et al., 2022).\n\nThe proposed hypothesis regarding the mechanism of action in hydrodilatation and pain reduction in patients with frozen shoulder was associated with synovitis and fibrosis removal. Previous studies also noted better pain reduction in patients receiving hydrodilatation with adjuvant corticosteroid than only corticosteroid injection (Albana et al., 2022).\n\nSeveral other adjuvants were studied in frozen shoulder treatment using hydrodilatation. The hydrodilatation method can cause pain in the shoulder during the intervention, so early manual exercise after the intervention is required to inhibit pain (Wang et al., 2021).\n\nHyaluronidases are a family of enzymes that catalyze the degradation of hyaluronic acid. By catalyzing the hydrolysis of hyaluronan, a constituent of the extracellular matrix, hyaluronidase lowers the viscosity of hyaluronan, thereby increasing the tissue permeability of injected solutes (Lee et al., 2021).\n\nAccordingly, hyaluronidase is used in medicine in conjunction with other drugs, including steroids, to speed their dispersion and delivery. There is growing evidence that using a steroid in combination with hyaluronidase in shoulder joints or spinal epidural spaces both maximizes the anti-inflammatory properties of the steroid and minimizes the side effects of steroid therapy (Manna et al., 2020).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:1- Patients diagnosed with unilateral frozen shoulder. 2- Diagnosis of frozen shoulder will be based on clinical examination (restriction of passive external rotation in the affected shoulder \\> 50% compared to the opposite side), in the presence of normal plain radiographs (anteroposterior and axillary projections other than calcific tendinopathy).\n\n3- Patients with symptoms for more than three months but less than one year which has not improved with medications and physiotherapy.\n\n4- aged 30 to 70 years old\n\nExclusion Criteria:\n\n1. History of trauma to the shoulder.\n2. History of fracture or dislocation around the shoulder.\n3. Inflammatory arthritis\n4. coagulation disorders\n5. History of previous injections within three months.\n6. Cervical radiculopathy.'}, 'identificationModule': {'nctId': 'NCT06129006', 'briefTitle': 'Ultrasound Guided Shoulder Anterior Capsular Infiltration Plus Hydrodilatation With Steroid Versus Hyalase in Patients With Frozen Shoulder', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Ultrasound Guided Shoulder Anterior Capsular Infiltration Plus Hydrodilatation With Steroid Versus Hyalase in Patients With Frozen Shoulder', 'orgStudyIdInfo': {'id': 'frozen shoulder'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A shoulder anterior capsular infiltration plus hydrodilatation with steroids.', 'description': '25 patients with frozen shoulders treated with ultrasound-guided shoulder anterior capsular infiltration plus hydrodilatation with steroids.', 'interventionNames': ['Procedure: hydrodilatation with steroid in group A versus hyalase in group B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'groupB shoulder anterior capsular infiltration plus hydrodilatation with hyalase.', 'description': '25 patients with frozen shoulders treated with ultrasound-guided shoulder anterior capsular infiltration plus hydrodilatation with hyalase.', 'interventionNames': ['Procedure: hydrodilatation with steroid in group A versus hyalase in group B']}], 'interventions': [{'name': 'hydrodilatation with steroid in group A versus hyalase in group B', 'type': 'PROCEDURE', 'description': 'Hydrodilatation technique:\n\nthe ultrasound transducer will be placed on the posterior surface of the shoulder in the longitudinal plane to identify the posterior glenohumeral joint, bony glenoid, humeral head, and infraspinatus muscle.Then, after sterilizing the area to be injected, the needle will be advanced to the target point between the humeral head cartilage and the infraspinatus tendon using the ultrasound-guided in-plane technique.To ensure the injection into the glenohumeral joint, the Doppler mode will be used to confirm the widening of the space between the humeral cartilage and the innermost synovial line of the infraspinatus muscle by the injected solution.', 'armGroupLabels': ['group A shoulder anterior capsular infiltration plus hydrodilatation with steroids.', 'groupB shoulder anterior capsular infiltration plus hydrodilatation with hyalase.']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ahmed Yehia Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}