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Completed

NCT Number: NCT06493656

Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation

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.

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Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwondo, 700-204, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Ultrasound-guided glenohumeral space isolated corticosteroid injection

Procedure

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.

Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection

Procedure

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.

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

Drug

1mL of Triamcinolone 40mg/1mL solution was included in the injection/hydrodilatation regimen.

4mL of Lidocaine 1% Solution Injectable Solution

Drug

4mL of 1% Lidocaine solution was included in the injection/hydrodilatation regimen.

15mL of Normal Saline

Drug

15mL of 1% Lidocaine solution was included in the hydrodilatation regimen.

Primary outcomes

  1. American Shoulder and Elbow Surgeons (ASES) shoulder score

    Time frame: Change from the baseline to 7 weeks

    Patient-reported shoulder satisfaction score, 0-100, higher scores mean a better outcome.

Secondary outcomes

  1. 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)

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Registry information

Official study 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

Acronym: CSvsCSHD

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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