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Adhesive CapsulitisCSvsCSHDNCT06493656

Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation

A study testing Ultrasound-guided glenohumeral space isolated corticosteroid injection, Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection and 1mL of Triamcinolone (40mg/1mL) Injectable Solution in people with Adhesive Capsulitis and Adhesive Capsulitis of Shoulder, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 80 years
What is being tested?
Ultrasound-guided glenohumeral space isolated corticosteroid injection, Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection and 1mL of Triamcinolone (40mg/1mL) Injectable Solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSouth Korea
Study dates
5 Dec 2013to 17 Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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˚

Who cannot join

  • 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%

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Chuncheon Sacred Heart Hospital

    Chuncheon, Gangwondo, 700-204

Other trials in South Korea

About this study

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

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?
Read more

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.

Being tested
Ultrasound-guided glenohumeral space isolated corticosteroid injection, Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection, 1mL of Triamcinolone (40mg/1mL) Injectable Solution, 4mL of Lidocaine 1% Solution Injectable Solution, 15mL of Normal Saline
Keywords
Glenohumeral injection, Hydrodilatation, Corticosteroid injection
Medical subject headings
Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-guided glenohumeral space isolated corticosteroid injectionProcedure or surgery

    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 injectionProcedure or surgery

    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 SolutionDrug

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

  • 4mL of Lidocaine 1% Solution Injectable SolutionDrug

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

  • 15mL of Normal SalineDrug

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

Study groups in NCT06493656
Study groupRoleWhat they receive
Isolated corticosteroid injectionExperimentalUltrasound-guided posterior approach of glenohumeral space injection for adhesive capsulitis of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine.
Receives: Procedure: Ultrasound-guided glenohumeral space isolated corticosteroid injection; Drug: 1mL of Triamcinolone (40mg/1mL) Injectable Solution; Drug: 4mL of Lidocaine 1% Solution Injectable Solution
Concomitant hydrodilatation with corticosteroid injectionActive comparatorUltrasound-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
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Change from the baseline to 7 weeks

Secondary outcomes (3)
  1. Range of motion (ROM)

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

    Measured: 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

    Measured: 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.

    Measured: Change from the baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2024
  2. Study start5 Dec 2013
  3. Primary completion17 Nov 2015
  4. Study completion17 Nov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06493656
Sponsor's protocol ID
CSvsCSHD
Acronym
CSvsCSHD
Status last verified
Jul 2026
First submitted
24 Jun 2024
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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
  • Kim YT, Hwang JT, Han SH, Hong MS, Lee JB. Simplified, single-shot, capsule-preserving hydrodilatation combined with corticosteroids versus isolated corticosteroid injection for adhesive capsulitis: a randomized controlled trial. J Orthop Surg Res. 2026 Sep 6;21(1):613. doi: 10.1186/s13018-026-07215-2.

    PubMed 42947148

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-guided glenohumeral space isolated corticosteroid injection, Ultrasound-guided glenohumeral space concomitant hydrodilatation with corticosteroid injection and 1mL of Triamcinolone (40mg/1mL) Injectable Solution in people with Adhesive Capsulitis and Adhesive Capsulitis of Shoulder, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

American Shoulder and Elbow Surgeons (ASES) shoulder score (time frame: Change from the baseline to 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06493656, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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