Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05668286
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2022-05-16
Brief 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
Sponsor:
Kartal City Hospital
Organization:
Kartal City Hospital
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 most radiological findings are detected
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 findings Patients with radiological finding of any tear in the rotator cuff or long head of biceps tendons were excluded Only patients in the freezing or frozen stage of the disease were included Patients who were previously treated with the diagnosis of adhesive caspulitis or who received any injections to the shoulder joint were not included in the study Included patients were randomly divided into two groups according to age sex duration of complaint concomitant diabetes mellitus DM disease and clinical stage of the disease For randomization stratified randomization was applied according to the information obtained from the outpatient clinic While 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 mgmL and 1 mL of prilocaine hydrochloride 2 were injected to all patients Patients were first evaluated before injection than randomized to groups and prospectively followed up by an orthopaedic surgeon who was blinded to the groups Evaluation was done for pain visual analog scale score VAS functional status American Shoulder and Elbow Surgeons score ASES and Quick Disabilities of the Arm Shoulder and Hand Quick DASH and active shoulder joint range of motion ROM angles at 1 3 and 6 weeks after the injection Means and standard deviations of were noted for each measurement period and each group Improvements in each period between the groups and differences between the preinjection values and each follow-up period between the groups were analyzed using Ficher exact test independent-samples t tests and Manova test P 05 was considered significant
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 findings Patients with radiological finding of any tear in the rotator cuff or long head of biceps tendons were excluded Only patients in the freezing or frozen stage of the disease were included Patients who were previously treated with the diagnosis of adhesive caspulitis or who received any injections to the shoulder joint were not included in the study Included patients were randomly divided into two groups according to age sex duration of complaint concomitant diabetes mellitus DM disease and clinical stage of the disease For randomization stratified randomization was applied according to the information obtained from the outpatient clinic While 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 mgmL and 1 mL of prilocaine hydrochloride 2 were injected to all patients Patients were first evaluated before injection than randomized to groups and prospectively followed up by an orthopaedic surgeon who was blinded to the groups Evaluation was done for pain visual analog scale score VAS functional status American Shoulder and Elbow Surgeons score ASES and Quick Disabilities of the Arm Shoulder and Hand Quick DASH and active shoulder joint range of motion ROM angles at 1 3 and 6 weeks after the injection Means and standard deviations of were noted for each measurement period and each group Improvements in each period between the groups and differences between the preinjection values and each follow-up period between the groups were analyzed using Ficher exact test independent-samples t tests and Manova test P 05 was considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None