Isolated Glenohumeral Corticosteroid Injection Versus Concomitant Capsule Preserving Hydrodilatation

NCT06493656 | Completed DMC

• 1 other identifier: CSvsCSHD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Glenohumeral injection; Hydrodilatation; Corticosteroid injection

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS) for pain

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

  Change from the baseline to 6 months

Secondary Outcomes (3)

• Range of motion (ROM)

  Change from the baseline to 6 months

• American Shoulder and Elbow Surgeons (ASES) shoulder score

  Change from the baseline to 6 months

• Constant-Murley score

  Change from the baseline to 6 months

Study Arms (2)

Isolated corticosteroid injection

EXPERIMENTAL

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

Concomitant hydrodilatation with corticosteroid injection

ACTIVE COMPARATOR

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

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.

Isolated corticosteroid injection

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.

Concomitant hydrodilatation with corticosteroid injection

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

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

Concomitant hydrodilatation with corticosteroid injection; Isolated corticosteroid injection

4mL of Lidocaine 1% Solution Injectable Solution DRUG

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

Concomitant hydrodilatation with corticosteroid injection; Isolated corticosteroid injection

15mL of Normal Saline DRUG

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

Concomitant hydrodilatation with corticosteroid injection

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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˚

You may not qualify if:

• 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%

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwondo, 700-204, South Korea

Location

Related Publications (6)

• 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.

  PMID: 20110457 RESULT

• 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.

  PMID: 32117540 RESULT

• 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.

  PMID: 30632986 RESULT

• 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.

  PMID: 29129609 RESULT

• 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.

  PMID: 21816628 RESULT

• 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.

  PMID: 28002160 RESULT

MeSH Terms

Conditions

Bursitis

Interventions

Adrenal Cortex Hormones; Triamcinolone; Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jung Taek Hwang, MD, PhD

  Chuncheon Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A final number of 50 patients were enrolled in the trial and randomly assigned to either the isolated corticosteroid injection group (Group CS) or the concomitant hydrodilatation group (Group CSHD). Double-blinded randomization was performed by an independent nurse using a computer-generated random sequence. A musculoskeletal radiologist, blinded to group allocation, performed the diagnostic ultrasound and MRI interpretations. A blinded orthopaedic nurse carried out the physical examination and clinical scoring.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 10, 2024
• Study Start: December 5, 2013
• Primary Completion: November 17, 2015
• Study Completion: November 17, 2015
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)