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The goal of this study is to detect if there is an additional benefit to performing ultrasound-guided hydrorelease of the coracohumeral ligament in patients with adhesive capsulitis of the shoulder receiving ultrasound-guided hydrodilatation.
This study is organised as double-blind, randomised controlled trial. Written informed consent will be taken from all the patients participating to the study. Inclusion Criteria Patients between the ages of 30 and 70, who have complaints of shoulder pain and limitation in the shoulder for at least 3 months and are diagnosed with Adhesive Capsulitis by clinical examination, will be included in the study. Exlusion Criteria 1. A history of physical therapy or injections for the shoulder joint within the previous three months, 2. The existence of a neurological condition or surgical history that could impair upper limb functions, 3. Being a breastfeeding or pregnant woman, 4. Mental illnesses and cognitive impairments that impair cooperation 5. Diabetes mellitus with unregulated glucose levels 6. Presenece of Cancer Patients included in the study will be divided into two groups by block randomization. In group 1, hydrodilatation will be performed with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. Fluid injection will continue until distension is observed in the shoulder joint capsule by ultrasonography. The amount of fluid given will be recorded. The second group will undergo hydrodilatation with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. Additionally, with ultrasonographic evaluation, 2 cc of physiological saline will be injected into the corocohumeral ligament. All the patients will be evaluated by a doctor who is blind to the study groups. Demographic information, history of shoulder pain, presence of chronic diseases, pain severity measured by VAS during resting,activity and sleep will be recorded. Physical examination including shoulder range of motion, will be evaluated. Shoulder Disability Index will be used for evaluating the functional status of shoulder. They will be evaluated before and immediately after injection, 1 week later, 1 month and 3 months after injection with VAS, shoulder range of motion and Shoulder Disability Index.
Age
30 - 70 years
Sex
ALL
Healthy Volunteers
No
Health Science University Haydarpasa Numune Research and Training Hospital
Istanbul, Uskudar, Turkey (Türkiye)
Start Date
December 18, 2023
Primary Completion Date
March 15, 2025
Completion Date
March 15, 2025
Last Updated
April 2, 2025
63
ACTUAL participants
Triamcinolone Acetonide
DRUG
Lead Sponsor
Haydarpasa Numune Training and Research Hospital
NCT07328295
NCT07057037
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07203963