Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder
Primary Purpose
Direct Coracohumeral Ligament Steroid Injection
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Intraarticular triamcinolone injection
Intraarticular Xylocaine injection
Coracohumeral ligament triamcinolone injection
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Direct Coracohumeral Ligament Steroid Injection focused on measuring adhesive capsulitis
Eligibility Criteria
A.Inclusion criteria:
- Age 20-80 years old
- Unilateral shoulder pain more than 3 months
- At least one shoulder ROM limitation in three dimensions which decreased over 50% (Abduction, Flexion, External rotation)
- Visual analog scale more than 30 (total 100)
- No fracture or subluxation or arthritis in shoulder Xray.
B.Exclusion criteria:
- History of shoulder or chest surgery
- History of shoulder trauma in 2 recent years
- Ever receiving shoulder joint injection in recent 3 months
- With cervical radiculopathy or any central CNS disorders
- With osteoarthritis or rheumatic arthritis of shoulder
- Diagnosed as rotator cuff tear, tendon calcification or bursitis
- Systemic diseases including diabetes or thyroid disorder
- Allergy history of steroid
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PT+IA+CHL
PT+IA
Arm Description
Intraarticular triamcinolone injection Intraarticular Xylocaine injection Coracohumeral ligament triamcinolone injection Physiotherapy
Intraarticular triamcinolone injection Intraarticular Xylocaine injection Physiotherapy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change of Visual analogue scale
Visual analogue scale: scale 0-10
Shoulder range of motion improvement
Range of motion improvement: flexion, abduction, external rotation (degree)
Stiffness of coracohumeral ligament under elastogram (KPa)
Full Information
NCT ID
NCT03013205
First Posted
December 26, 2016
Last Updated
January 5, 2017
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03013205
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2017 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Direct Coracohumeral Ligament Steroid Injection
Keywords
adhesive capsulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PT+IA+CHL
Arm Type
Experimental
Arm Description
Intraarticular triamcinolone injection
Intraarticular Xylocaine injection
Coracohumeral ligament triamcinolone injection
Physiotherapy
Arm Title
PT+IA
Arm Type
Active Comparator
Arm Description
Intraarticular triamcinolone injection
Intraarticular Xylocaine injection
Physiotherapy
Intervention Type
Procedure
Intervention Name(s)
Intraarticular triamcinolone injection
Intervention Description
triamcinolone 10mg/mL
Intervention Type
Procedure
Intervention Name(s)
Intraarticular Xylocaine injection
Intervention Description
Xylocaine 1% 4ml
Intervention Type
Procedure
Intervention Name(s)
Coracohumeral ligament triamcinolone injection
Intervention Description
triamcinolone 10mg/mL
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy
Primary Outcome Measure Information:
Title
Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement
Description
shoulder function improvement (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash), score 0-100
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change of Visual analogue scale
Description
Visual analogue scale: scale 0-10
Time Frame
2 years
Title
Shoulder range of motion improvement
Description
Range of motion improvement: flexion, abduction, external rotation (degree)
Time Frame
2 years
Title
Stiffness of coracohumeral ligament under elastogram (KPa)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
A.Inclusion criteria:
Age 20-80 years old
Unilateral shoulder pain more than 3 months
At least one shoulder ROM limitation in three dimensions which decreased over 50% (Abduction, Flexion, External rotation)
Visual analog scale more than 30 (total 100)
No fracture or subluxation or arthritis in shoulder Xray.
B.Exclusion criteria:
History of shoulder or chest surgery
History of shoulder trauma in 2 recent years
Ever receiving shoulder joint injection in recent 3 months
With cervical radiculopathy or any central CNS disorders
With osteoarthritis or rheumatic arthritis of shoulder
Diagnosed as rotator cuff tear, tendon calcification or bursitis
Systemic diseases including diabetes or thyroid disorder
Allergy history of steroid
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chueh-Hung Wu
Phone
0972651208
Email
nojred@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chueh-Hung Wu, MD
Organizational Affiliation
NTUH PMR
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Test1
State/Province
Test2
ZIP/Postal Code
test3
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chueh-Hung Wu, MD
Phone
0972651208
Email
nojred@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder
We'll reach out to this number within 24 hrs