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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06202963
Other study ID # HNEAH-KAEK/KK/2023/210
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 18, 2023
Est. completion date July 30, 2024

Study information

Verified date January 2024
Source Haydarpasa Numune Training and Research Hospital
Contact Sibel Suzen Ozbayrak, M.D.
Phone +905063438187
Email sibels62@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 2 months after injection with VAS, shoulder range of motion and Shoulder Disability Index.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date July 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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: 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. Presence of Cancer

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Triamcinolone Acetonide
group will receive ultrasound-guided hydrodilatation group will receive ultarsound-guided coracohumeral hydrorelease in addition to the ultrasound-guided hydrodilaltation of shoulder

Locations

Country Name City State
Turkey Health Science University Haydarpasa Numune Research and Training Hospital Istanbul Uskudar

Sponsors (1)

Lead Sponsor Collaborator
Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analouge Scale (VAS) Pain Severity Before and immediately after injection, 1 week,1 month and 2 moths after injection
Primary Shoulder Range of Motion Shoulder Limitation Before and immediately after injection, 1 week,1 month and 2 moths after injection
Primary Shoulder Disability Index Shouler Disability Before injection, 1 week,1 month and 2 moths after injection
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