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

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.

Study Overview

• Status: Unknown
• Conditions: Direct Coracohumeral Ligament Steroid Injection
• Intervention / Treatment: Procedure: Physiotherapy; Procedure: Intraarticular triamcinolone injection; Procedure: Intraarticular Xylocaine injection; Procedure: Coracohumeral ligament triamcinolone injection

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Test2
    • Test1, Test2, Taiwan, test3
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chueh-Hung Wu, MD, NTUH PMR

Study record dates

Study Major Dates

• Study Start: February 1, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: December 26, 2016
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Estimate): January 6, 2017
• Last Update Submitted That Met QC Criteria: January 5, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: adhesive capsulitis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 201609026RINB