Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation (CSvsCSHD)

Chuncheon Sacred Heart Hospital

Status: Completed

Conditions: Adhesive Capsulitis of Shoulder; Adhesive Capsulitis

Treatments: Procedure: Ultrasound-guided glenohumeral space isolated corticosteroid injection; Drug: 15mL of Normal Saline; Procedure: Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection; Drug: 4mL of Lidocaine 1% Solution Injectable Solution; Drug: 1mL of Triamcinolone (40mg/1mL) Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06493656

CSvsCSHD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Two or more of the following criteria within the shoulder's range of motion:

• Abduction and forward elevation below 100˚
• External rotation at the side below 30˚
• Internal rotation at 90˚ of abduction below 30˚

Exclusion criteria

• History of shoulder surgery, trauma, nerve injury
• Concomitant rotator cuff/biceps lesions in ultrasound or MRI
• Glenohumeral arthritis in simple X-ray
• Calcific tendinosis in simple X-ray
• Underlying conditions: cancer, mental illness, hormonal imbalance
• Diabetes with HbA1c levels exceeding 7.0%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Isolated corticosteroid injection

Experimental group

Description:

Ultrasound-guided posterior approach of glenohumeral space injection for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine.

Treatment:

Drug: 1mL of Triamcinolone (40mg/1mL) Injectable Solution

Drug: 4mL of Lidocaine 1% Solution Injectable Solution

Procedure: Ultrasound-guided glenohumeral space isolated corticosteroid injection

Concomitant hydrodilatation with corticosteroid injection

Active Comparator group

Description:

Ultrasound-guided posterior approach of glenohumeral space hydrodilatation for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, and 15 mL normal saline

Treatment:

Drug: 1mL of Triamcinolone (40mg/1mL) Injectable Solution

Drug: 4mL of Lidocaine 1% Solution Injectable Solution

Procedure: Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection

Drug: 15mL of Normal Saline