Clinical trial NCT03013205: Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder
Official title: Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Direct Coracohumeral Ligament Steroid Injection
Keywords: adhesive capsulitis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement
timeFrame: 2 years
Secondary outcomes:
measure: Change of Visual analogue scale
timeFrame: 2 years
measure: Shoulder range of motion improvement
timeFrame: 2 years
measure: Stiffness of coracohumeral ligament under elastogram (KPa)
timeFrame: 2 years
Other outcomes:
Locations:
city: Test1
country: Taiwan
facility: National Taiwan University Hospital
state: Test2
Study officials:
affiliation: NTUH PMR
name: Chueh-Hung Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: