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

Direct Coracohumeral Ligament Steroid Injection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03013205
• Other study ID #: 201609026RINB
• Status: Not yet recruiting
• Phase: N/A
• First received: December 26, 2016
• Last updated: January 5, 2017
• Start date: February 2017
• Est. completion date: October 2018

Study information

• Verified date: January 2017
• Source: National Taiwan University Hospital
• Contact: Chueh-Hung Wu
• Phone: 0972651208
• Email: nojred[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

A.Inclusion criteria:

1. Age 20-80 years old

2. Unilateral shoulder pain more than 3 months

3. At least one shoulder ROM limitation in three dimensions which decreased over 50% (Abduction, Flexion, External rotation)

4. Visual analog scale more than 30 (total 100)

5. No fracture or subluxation or arthritis in shoulder Xray.

B.Exclusion criteria:

1. History of shoulder or chest surgery

2. History of shoulder trauma in 2 recent years

3. Ever receiving shoulder joint injection in recent 3 months

4. With cervical radiculopathy or any central CNS disorders

5. With osteoarthritis or rheumatic arthritis of shoulder

6. Diagnosed as rotator cuff tear, tendon calcification or bursitis

7. Systemic diseases including diabetes or thyroid disorder

8. Allergy history of steroid

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bursitis
• Direct Coracohumeral Ligament Steroid Injection

Intervention

Procedure:
• Intraarticular triamcinolone injection
triamcinolone 10mg/mL
• Intraarticular Xylocaine injection
Xylocaine 1% 4ml
• Coracohumeral ligament triamcinolone injection
triamcinolone 10mg/mL
• Physiotherapy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Test1	Test2

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change of Visual analogue scale	Visual analogue scale: scale 0-10	2 years	No
Secondary	Shoulder range of motion improvement	Range of motion improvement: flexion, abduction, external rotation (degree)	2 years	No
Secondary	Stiffness of coracohumeral ligament under elastogram (KPa)		2 years	No