Health Science University Haydarpasa Numune Research and Training Hospital
Istanbul, Uskudar, 34668, Turkey (Türkiye)
NCT Number: NCT06202963
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.
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Notify Me30 year–70 year
All sexes
Interventional
Not applicable
Istanbul, Uskudar, 34668, Turkey (Türkiye)
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients between the ages of 30 and 70 who have complained of shoulder pain and limitation in the shoulder for at least 3 months and have been diagnosed with adhesive capsulitis by clinical examination will be included in the study.
Exclusion criteria
Other names: lidocaine, serum physiologic
Time frame: Before and immediately after injection, 1 week,1 month and 2 moths after injection
Pain Severity
Time frame: Before and immediately after injection, 1 week,1 month and 2 moths after injection
Shoulder Limitation
Time frame: Before injection, 1 week,1 month and 2 moths after injection
Shouler Disability
Haydarpasa Numune Training and Research Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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