Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder

Not Applicable

• Conditions: Direct Coracohumeral Ligament Steroid Injection

• Registration Number: NCT03013205
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Steroid injections are widely utilized to reduce inflammation and fibrosis in patients with the frozen shoulder. In this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. Investigators will measure the primary outcome as shoulder function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral ligament under elastogram.

Detailed Description

Adhesive capsulitis of the shoulder, also known as the frozen shoulder, often leads to severe pain and shoulder range of motion limitation. Steroid injections are widely utilized to reduce inflammation and fibrosis. The thickening of the coracohumeral ligament was thought to play an important role in the pathogenesis of frozen shoulder, resulting in limited external rotation of the shoulder. While the elastogram of coracohumeral ligament will significantly increase stiffness under the shear-wave ultrasound (shear-wave elastography).

Therefore, in this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. Investigators will measure the primary outcome as shoulder function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral ligament under elastogram.

(the patient will not have additional risk of injection under ultrasound guidance)

Study Timeline

• Study First Submitted: 2016-12-26
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-05
• Last Update Submitted: 2017-01-05
• Study First Posted: 2017-01-06
• Last Update Posted: 2017-01-06
• Study Start: 2017-02
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement	2 years	shoulder function improvement (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash), score 0-100

Secondary Outcome Measures

Name	Time	Method
Change of Visual analogue scale	2 years	Visual analogue scale: scale 0-10
Stiffness of coracohumeral ligament under elastogram (KPa)	2 years
Shoulder range of motion improvement	2 years	Range of motion improvement: flexion, abduction, external rotation (degree)

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Test1, Test2, Taiwan

National Taiwan University Hospital

🇨🇳Test1, Test2, Taiwan

Chueh-Hung Wu, MD

Contact

0972651208

nojred@gmail.com