Clinical trial NCT06493656: Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Adhesive Capsulitis of Shoulder
Keywords: Glenohumeral injection
Hydrodilatation
Corticosteroid injection
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study group underwent ultrasound-guided posterior approach of glenohumeral space injection for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 7 mL normal saline.

Control group underwent ultrasound-guided posterior approach of glenohumeral space HYDRODILATATION for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 15 mL normal saline.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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%

Primary outcomes:
measure: Visual analog scale (VAS) for pain
timeFrame: Change from the baseline to 6 months
Secondary outcomes:
measure: Range of motion (ROM)
timeFrame: Change from the baseline to 6 months
measure: American Shoulder and Elbow Surgeons (ASES) shoulder score
timeFrame: Change from the baseline to 6 months
measure: Constant-Murley score
timeFrame: Change from the baseline to 6 months
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Gangwondo
Study officials:
affiliation: Chuncheon Sacred Heart Hospital
name: Jung Taek Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Redler LH, Dennis ER. Treatment of Adhesive Capsulitis of the Shoulder. J Am Acad Orthop Surg. 2019 Jun 15;27(12):e544-e554. doi: 10.5435/JAAOS-D-17-00606.
citation: Catapano M, Mittal N, Adamich J, Kumbhare D, Sangha H. Hydrodilatation With Corticosteroid for the Treatment of Adhesive Capsulitis: A Systematic Review. PM R. 2018 Jun;10(6):623-635. doi: 10.1016/j.pmrj.2017.10.013. Epub 2017 Nov 10.
citation: Oh JH, Oh CH, Choi JA, Kim SH, Kim JH, Yoon JP. Comparison of glenohumeral and subacromial steroid injection in primary frozen shoulder: a prospective, randomized short-term comparison study. J Shoulder Elbow Surg. 2011 Oct;20(7):1034-40. doi: 10.1016/j.jse.2011.04.029. Epub 2011 Aug 4.
citation: Kim DY, Lee SS, Nomkhondorj O, Cho MG, Lee JJ, Hwang JT, Hong MS. Comparison Between Anterior and Posterior Approaches for Ultrasound-Guided Glenohumeral Steroid Injection in Primary Adhesive Capsulitis: A Randomized Controlled Trial. J Clin Rheumatol. 2017 Jan;23(1):51-57. doi: 10.1097/RHU.0000000000000475. No abstract available.