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.

Adhesive Capsulitis of the Shoulder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05668286
• Other study ID #: KartalCity-ERGUN-001
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2024
• Est. completion date: December 24, 2024

Study information

• Verified date: March 2024
• Source: Kartal City Hospital
• Contact: OMER FARUK SEVIM, MD
• Phone: +905382884306
• Email: dromerfaruksevim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 mg/mL) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 24, 2024
• Est. primary completion date: November 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• must be between the ages of 18-75

• clinically and radiologically confirmed adhesive capsulitis

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adhesive Capsulitis of the Shoulder
• Bursitis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Turkey	Kartal Dr Lutfi Kirdar City Hospital	Istanbul	Kartal

Sponsors (1)

Lead Sponsor	Collaborator
Kartal City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.