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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Direct Coracohumeral Ligament Steroid Injection

Intervention / Treatment
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* Procedure: Intraarticular triamcinolone injection
* Procedure: Intraarticular Xylocaine injection
* Procedure: Coracohumeral ligament triamcinolone injection
* Procedure: Physiotherapy


Participation Criteria
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Eligibility Criteria
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A.Inclusion criteria： Age 20-80 years old Unilateral shoulder pain more than 3 months At least one shoulder ROM limitation in three dimensions which decreased over 50% (Abduction, Flexion, External rotation) Visual analog scale more than 30 (total 100) No fracture or subluxation or arthritis in shoulder Xray. B.Exclusion criteria： History of shoulder or chest surgery History of shoulder trauma in 2 recent years Ever receiving shoulder joint injection in recent 3 months With cervical radiculopathy or any central CNS disorders With osteoarthritis or rheumatic arthritis of shoulder Diagnosed as rotator cuff tear, tendon calcification or bursitis Systemic diseases including diabetes or thyroid disorder Allergy history of steroid

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PT+IA+CHL<br>Intraarticular triamcinolone injection Intraarticular Xylocaine injection Coracohumeral ligament triamcinolone injection Physiotherapy | Procedure: Intraarticular triamcinolone injection<br>* triamcinolone 10mg/mL<br>Procedure: Intraarticular Xylocaine injection<br>* Xylocaine 1% 4ml<br>Procedure: Coracohumeral ligament triamcinolone injection<br>* triamcinolone 10mg/mL<br>Procedure: Physiotherapy<br> <br> |
| Active Comparator: PT+IA<br>Intraarticular triamcinolone injection Intraarticular Xylocaine injection Physiotherapy | Procedure: Intraarticular triamcinolone injection<br>* triamcinolone 10mg/mL<br>Procedure: Intraarticular Xylocaine injection<br>* Xylocaine 1% 4ml<br>Procedure: Physiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement | shoulder function improvement (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash), score 0-100 | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adhesive capsulitis