NCT06493656

Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation

The Efficacy of Single-shot Capsule-preserving Hydrodilatation With Corticosteroids in Treating Adhesive Capsulitis of the Shoulder: A Randomized Controlled Trial Versus Isolated Corticosteroid Injection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Chuncheon Sacred Heart Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial investigates whether concomitant capsule-preserving hydrodilatation (CSHD) is more effective than isolated glenohumeral corticosteroid injection (CS) in treating shoulder adhesive capsulitis. The main questions it aims to answer are * Is CSHD inferior to CS in immediate pain relief as the solution is diluted? * Is CSHD superior to CS in improving the range of motion as the contracted capsule is dilated? Group CS will receive an ultrasound-guided glenohumeral corticosteroid injection only, with a solution of 5 mL. Group CSHD will receive an ultrasound-guided glenohumeral corticosteroid with hydrodilatation, with a solution of 20 mL. Clinical scores and range of motion will be compared between the groups up to six months post-injection.

Detailed description

A single-centre, double-blinded, prospective randomised controlled trial involving patients diagnosed with adhesive capsulitis of the shoulder (AC). Patients were randomly allocated to either corticosteroid injection with hydrodilatation (group CSHD) or corticosteroid injection only (group CS). For the CS group, a solution of 1 mL triamcinolone (40mg) and 4 mL 1% lidocaine, 5 mL in total, was injected intraarticularly through the posterior approach using ultrasound guidance. The CSHD group received an injection of 20 mL with 15 mL of normal saline added to the abovementioned 5 mL solution. The dilatation of the joint capsule was confirmed by the increase in distance between the capsule and the humeral head. Patients underwent the following assessments just before the injection, and at post-injection three weeks, seven weeks, three months, and six months. Range of motion in forward elevation, external rotation, and internal rotation Clinical scores include the pain visual analogue scale (pVAS), the American Shoulder and Elbow Surgeons score, and the Constant-Murley score. Subjective patient satisfaction was recorded on a scale from 0 to 100, with 100 being the most satisfied. The recorded data were compared within each group before and after the injection, and also between the groups.

Conditions

• Adhesive Capsulitis
• Adhesive Capsulitis of Shoulder

Interventions

Type	Name	Description
PROCEDURE	Ultrasound-guided glenohumeral space isolated corticosteroid injection	Using a 21-gauge spinal needle, the predefined steroid solution was injected under ultrasound guidance using 5- to 13-MHz linear probe into the glenohumeral space through the posterior approach.
PROCEDURE	Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection	Using a 21-gauge spinal needle, the predefined steroid solution with additional 15 mL of normal saline was injected under ultrasound guidance using 5- to 13-MHz linear probe into the glenohumeral space through the posterior approach.
DRUG	1mL of Triamcinolone (40mg/1mL) Injectable Solution	1mL of Triamcinolone 40mg/1mL solution was included in the injection/hydrodilatation regimen.
DRUG	4mL of Lidocaine 1% Solution Injectable Solution	4mL of 1% Lidocaine solution was included in the injection/hydrodilatation regimen.
DRUG	15mL of Normal Saline	15mL of 1% Lidocaine solution was included in the hydrodilatation regimen.

Timeline

• Start date: 2013-12-05
• Primary completion: 2015-11-17
• Completion: 2015-11-17
• First posted: 2024-07-10
• Last updated: 2024-07-10

Locations

1 site across 1 country: South Korea