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

NCT ID: NCT03013205

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-28
• Study Completion Date: 2018-10-31

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)

Conditions

Direct Coracohumeral Ligament Steroid Injection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PT+IA+CHL

1. Intraarticular triamcinolone injection

2. Intraarticular Xylocaine injection

3. Coracohumeral ligament triamcinolone injection

4. Physiotherapy

Group Type: EXPERIMENTAL

Intraarticular triamcinolone injection

Intervention Type: PROCEDURE

triamcinolone 10mg/mL

Intraarticular Xylocaine injection

Intervention Type: PROCEDURE

Xylocaine 1% 4ml

Coracohumeral ligament triamcinolone injection

Intervention Type: PROCEDURE

triamcinolone 10mg/mL

Physiotherapy

Intervention Type: PROCEDURE

PT+IA

1. Intraarticular triamcinolone injection

2. Intraarticular Xylocaine injection

3. Physiotherapy

Group Type: ACTIVE_COMPARATOR

Intraarticular triamcinolone injection

Intervention Type: PROCEDURE

triamcinolone 10mg/mL

Intraarticular Xylocaine injection

Intervention Type: PROCEDURE

Xylocaine 1% 4ml

Physiotherapy

Intervention Type: PROCEDURE

Interventions

Intraarticular triamcinolone injection

triamcinolone 10mg/mL

Intervention Type: PROCEDURE

Intraarticular Xylocaine injection

Xylocaine 1% 4ml

Intervention Type: PROCEDURE

Coracohumeral ligament triamcinolone injection

triamcinolone 10mg/mL

Intervention Type: PROCEDURE

Physiotherapy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chueh-Hung Wu, MD

Role: PRINCIPAL_INVESTIGATOR

NTUH PMR

Locations

National Taiwan University Hospital

Test1, Test2, Taiwan

Countries

Taiwan

Central Contacts

Chueh-Hung Wu

Role: CONTACT

nojred@gmail.com

0972651208

Facility Contacts

Chueh-Hung Wu, MD

Role: primary

nojred@gmail.com

0972651208

Other Identifiers

201609026RINB

Identifier Type: -

Identifier Source: org_study_id