What Factors Area Associated With Prognosis After Steroid Hydrodilatation for Adhesive Capsulitis
Primary Purpose
Adhesive Capsulitis
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Steroid (shincort)
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis focused on measuring adhesive capsulitis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of frozen shoulder by physical examination and ultrasonography
Exclusion Criteria:
- other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region);
- neurologic deficits affecting shoulder function in normal daily activities;
- shoulder pain caused by cervical radiculopathy
- a history of drug allergy to xylocaine
- pregnancy or lactation;
- received injection into the affected shoulder during the preceding 3 months
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intraarticular steroid injection
Arm Description
intraarticular steroid hydrodilatation (shincort 40mg )
Outcomes
Primary Outcome Measures
The change of constant shoulder score between week 0 and week 8
the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength
Secondary Outcome Measures
pain intensity
pain intensity was measured by visual analog scale. Each patient was asked to indicate his/her current level of pain by marking a point on a 100-mm VAS, for which 0 represented no pain and 100 represented unbearable pain.
Shoulder Pain And disability index
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
glenohumeral joint range of motion
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position
Full Information
NCT ID
NCT03622853
First Posted
March 29, 2018
Last Updated
August 7, 2018
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT03622853
Brief Title
What Factors Area Associated With Prognosis After Steroid Hydrodilatation for Adhesive Capsulitis
Official Title
What Factors Area Associated With Prognosis After Steroid Hydrodilatation for Adhesive Capsulitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
March 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder
Detailed Description
Objective: To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder
Design: Prospective study.
Participants: Patients with Frozen shoulder were recorded the demographic data, associated disease, ultrasound findings at baselines.
Intervention: One shot intraarticular steroid hydrodilatation
Main Outcome Measures: Visual analog scale (VAS) of the shoulder pain, Constant score, SPADI score, and angles of active and passive shoulder range of motion (flexion, abduction, external rotation, and internal rotation) at pre-treatment, post-treatment at week 8
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
adhesive capsulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intraarticular steroid injection
Arm Type
Experimental
Arm Description
intraarticular steroid hydrodilatation (shincort 40mg )
Intervention Type
Drug
Intervention Name(s)
Steroid (shincort)
Other Intervention Name(s)
shincort
Intervention Description
intraarticular shincort 40mg / 4ml mixed with 2% xylocaine and Normal saline
Primary Outcome Measure Information:
Title
The change of constant shoulder score between week 0 and week 8
Description
the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength
Time Frame
0 and 8 wks
Secondary Outcome Measure Information:
Title
pain intensity
Description
pain intensity was measured by visual analog scale. Each patient was asked to indicate his/her current level of pain by marking a point on a 100-mm VAS, for which 0 represented no pain and 100 represented unbearable pain.
Time Frame
0 and 8 wks
Title
Shoulder Pain And disability index
Description
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
Time Frame
0 and 8 wks
Title
glenohumeral joint range of motion
Description
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position
Time Frame
0 and 8 wks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of frozen shoulder by physical examination and ultrasonography
Exclusion Criteria:
other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region);
neurologic deficits affecting shoulder function in normal daily activities;
shoulder pain caused by cervical radiculopathy
a history of drug allergy to xylocaine
pregnancy or lactation;
received injection into the affected shoulder during the preceding 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia chi c Wang, MD
Phone
919527693
Email
jcwang0726@gmail.com
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
241
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia c Wang
Phone
919527693
Email
jcwang0726@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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What Factors Area Associated With Prognosis After Steroid Hydrodilatation for Adhesive Capsulitis
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