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Clinical Trials/NCT03013205
NCT03013205
Unknown
Not Applicable

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

National Taiwan University Hospital1 site in 1 country60 target enrollmentStarted: February 2017Last updated:

Overview

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement

Time Frame: 2 years

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

Secondary Outcomes

  • Change of Visual analogue scale(2 years)
  • Stiffness of coracohumeral ligament under elastogram (KPa)(2 years)
  • Shoulder range of motion improvement(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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