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CompletedNCT06493656CSvsCSHDUpdated Jul 9, 2026

Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation

An interventional study of Ultrasound-guided glenohumeral space isolated corticosteroid injection and Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection in Adhesive Capsulitis and Adhesive Capsulitis of Shoulder, sponsored by Chuncheon Sacred Heart Hospital. Completed at 1 site in South Korea. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Chuncheon Sacred Heart Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 years 6 months after the study started (first participant enrolled Dec 2013, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
35 Years to 80 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Adhesive Capsulitis
  • Adhesive Capsulitis of Shoulder

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Keywords

  • Glenohumeral injection
  • Hydrodilatation
  • Corticosteroid injection
03

In context

Bursitis

411 studies on the registry are indexed under Bursitis; 112 are open to participants now.

This study's enrollment of 50 is above the median of 45 across 371 interventional studies indexed under Bursitis.

Browse Bursitis studies →

Lead sponsor

Chuncheon Sacred Heart Hospital is the lead sponsor of 55 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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%
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • 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 · Drug: 1mL of Triamcinolone (40mg/1mL) Injectable Solution · Drug: 4mL of Lidocaine 1% Solution Injectable Solution

  • 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

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

Interventions

  • ProcedureUltrasound-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.

  • ProcedureUltrasound-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.

  • Drug1mL of Triamcinolone (40mg/1mL) Injectable Solution

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

  • Drug4mL of Lidocaine 1% Solution Injectable Solution

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

  • Drug15mL of Normal Saline

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: Change from the baseline to 7 weeks

Secondary outcomes

  1. Range of motion (ROM)

    ROM in degrees, forward elevation (0-150), external rotation (0-90), and internal rotation (0-90)

    Time frame: Change from the baseline to 6 months

  2. Visual analog scale (VAS) for pain

    Patient-reported 0-10 scale of pain, 0: no pain, 10: very severe pain

    Time frame: Change from the baseline to 6 months

  3. Constant-Murley score

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

    Time frame: Change from the baseline to 6 months

07

Study locations

1 site
  • Chuncheon Sacred Heart Hospital
    Chuncheon, Gangwondo 700-204, South Korea
08

References and documents

Publications

  • Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28. PubMed 20110457 ↗
  • Cho CH, Lee YH, Kim DH, Lim YJ, Baek CS, Kim DH. Definition, Diagnosis, Treatment, and Prognosis of Frozen Shoulder: A Consensus Survey of Shoulder Specialists. Clin Orthop Surg. 2020 Mar;12(1):60-67. doi: 10.4055/cios.2020.12.1.60. Epub 2020 Feb 13. PubMed 32117540 ↗
  • 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. PubMed 30632986 ↗
  • 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. PubMed 29129609 ↗
  • 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. PubMed 21816628 ↗
  • 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. PubMed 28002160 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06493656
Lead sponsor
Chuncheon Sacred Heart Hospital
Responsible party
Jung-Taek Hwang (Professor, Chuncheon Sacred Heart Hospital) — Principal investigator
First posted
Jul 10, 2024
Start date
Dec 5, 2013
Primary completion
Nov 17, 2015
Completion
Nov 17, 2015
Last update
Jul 9, 2026

Study contacts

Jung Taek Hwang, MD, PhD
principal investigator · Chuncheon Sacred Heart Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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