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Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation

NCT06493656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-07-10

No results posted yet for this study

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.

Conditions

  • Adhesive Capsulitis
  • Adhesive Capsulitis of Shoulder

Interventions

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.

Sponsors & Collaborators

  • Chuncheon Sacred Heart Hospital

    lead OTHER

Principal Investigators

  • Jung Taek Hwang, MD, PhD · Chuncheon Sacred Heart Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-05
Primary Completion
2015-11-17
Completion
2015-11-17

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06493656 on ClinicalTrials.gov