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Clinical Trial NCT05668286 for Adhesive Capsulitis of the Shoulder is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Comparison of the Short-term Clinical Effects of Anterior Extra-articular and Posterior Intra-articular Administration of Ultrasound-guided Steroid Injection in the Treatment of Adhesive Capsulitis. 50 Short-Term
Clinical Trial NCT05668286 is an interventional study for Adhesive Capsulitis of the Shoulder that is recruiting. It started on May 24, 2024 with plans to enroll 50 participants. Led by Kartal City Hospital, it is expected to complete by December 24, 2024. The latest data from ClinicalTrials.gov was last updated on March 6, 2024.
Brief Summary
In the treatment of adhesive capsulitis, conservative treatment usually gives successful results, and steroid injection is an effective method that is frequently preferred among conservative treatment modalities. However, many controversial issues have not yet been clarified in the literature, such as the location of the injection, whether into the glenohumeral joint or around the coracohumeral ligament where the mos...Show More
Detailed Description
Purpose:
To compare the intra-articular steroid administration with the extra-articular one; around the coracohumeral ligament in patients with adhesive capsulitis.
Method:
Ethics committee approval was obtained for the study. Patients who were diagnosed with adhesive capsulitis in the orthopedic outpatient clinic were included. Diagnosis was confimed by physical examination and Magnetic Resonance Imaging (MRI) fi...
Show MoreOfficial Title
Comparison of the Short-term Clinical Effects of Anterior Extra-articular and Posterior Intra-articular Administration of Ultrasound-guided Steroid Injection in the Treatment of Adhesive Capsulitis. A Prospective, Randomized and Single-blind Study
Conditions
Adhesive Capsulitis of the ShoulderOther Study IDs
- KartalCity-ERGUN-001
NCT ID Number
Start Date (Actual)
2024-05-24
Last Update Posted
2024-03-06
Completion Date (Estimated)
2024-12-24
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
adhesive capsulitis
steroid injection
ultrasound-guided
steroid injection
ultrasound-guided
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active Comparatorposterior intra-articular steroid injection under USG guidance Intra-articular steroid injection will be performed to the glenohumeral joint from the posterior, 2cm inferior and 2cm medial of the acromion posterolateral corner, under the guidance of USG. | A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) patients in group 1 received an anterior extra-articular steroid injection under USG guidance, patients in group 2 received posterior intra-articular steroid injection under USG guidance. A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) were injected to all patients. |
Active Comparatoranterior extra-articular steroid injection under USG guidance Steroid injection will be performed from the anterior, immediately lateral to the coracoid process, to the CHL localization, to the extra-articular area under the guidance of USG. | A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) patients in group 1 received an anterior extra-articular steroid injection under USG guidance, patients in group 2 received posterior intra-articular steroid injection under USG guidance. A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) were injected to all patients. |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The Visual Analogue Scale(VAS) | The change of Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.We noted the changes within this scoring system between the time framed which is stated below | The change from the baseline of the Visual Analog Scale (VAS) score of the shoulder pain in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week. |
external rotation of shoulder | The change of external rotation of the shoulder will be measured by the Orthopedic Resident by goniometer. | The change from the baseline of external rotation of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week. |
abduction of shoulder | The change of abduction of the shoulder will be measured by the Orthopedic Resident by goniometer. | The change in shoulder abduction from the baseline over a 6-week period Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week. |
flexion of shoulder | The change of flexion of the shoulder will be measured by the Orthopedic Resident by a goniometer. | The change from the baseline of flexion of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week. |
Internal rotation of the shoulder | The change of Internal rotation of the shoulder will be measured by the Orthopedic Resident by Constant Shoulder Score | The change from the baseline of internal rotation of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- must be between the ages of 18-75
- clinically and radiologically confirmed adhesive capsulitis
- Patients with a tear in any of the rotator cuff tendons
- Patients who have had steroid injections in the shoulder region before
- patients who have been treated with the diagnosis of adhesive capsulitis (except for oral non-steroidal anti-inflammatory drug therapy)
- Patients with a previous history of trauma-fracture-dislocation in the shoulder region
Kartal City HospitalStudy Responsible Party
Omer Faruk Sevim, MD, Principal Investigator, Principal Investigator, Kartal City Hospital
Study Central Contact
Contact: OMER FARUK SEVIM, MD, +905382884306, [email protected]
1 Study Locations in 1 Countries
Kartal
Kartal Dr Lutfi Kirdar City Hospital, Istanbul, Kartal, Turkey (Türkiye)
Omer Faruk Sevim, Contact, +905382884306, [email protected]
Selim Ergun, Contact, +90 533 601 14 72, [email protected]
Recruiting