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

July 7, 2024 updated by: Jung-Taek Hwang, Chuncheon Sacred Heart Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangwondo
      • Chuncheon, Gangwondo, Korea, Republic of, 700-204
        • Chuncheon Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Isolated corticosteroid injection
Ultrasound-guided posterior approach of glenohumeral space injection for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine.
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.
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.
Active Comparator: Concomitant hydrodilatation with corticosteroid injection
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
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.
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: 15mL of Normal Saline
15mL of 1% Lidocaine solution was included in the hydrodilatation regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale (VAS) for pain
Time Frame: Change from the baseline to 6 months
Patient-reported 0-10 scale of pain, 0: no pain, 10: very severe pain
Change from the baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion (ROM)
Time Frame: Change from the baseline to 6 months
ROM in degrees, forward elevation (0-150), external rotation (0-90), and internal rotation (0-90)
Change from the baseline to 6 months
American Shoulder and Elbow Surgeons (ASES) shoulder score
Time Frame: Change from the baseline to 6 months
Patient-reported shoulder satisfaction score, 0-100, higher scores mean a better outcome.
Change from the baseline to 6 months
Constant-Murley score
Time Frame: Change from the baseline to 6 months
Patient-reported and healthcare provider-assessed shoulder satisfaction score, 0-100, higher scores mean a better outcome.
Change from the baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Investigators

  • Principal Investigator: Jung Taek Hwang, MD, PhD, Chuncheon Sacred Heart Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2013

Primary Completion (Actual)

November 17, 2015

Study Completion (Actual)

November 17, 2015

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

July 7, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 7, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSvsCSHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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