What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection
Primary Purpose
Rotator Cuff Impingement Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hyaluronic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Impingement Syndrome focused on measuring rotator cuff disorder
Eligibility Criteria
Inclusion criteria were patients
- with clinically and ultrasonographically diagnosed rotator cuff disease of the shoulder-impingement, tendinosis and tear;
- who reported shoulder pain more than 3 months;
Exclusion Criteria:
- presence of another medical or psychological condition, including cancer, rheumatoid arthritis, endocrine disease (i.e., diabetes), major depression, or schizophrenia;
- previous major trauma history at currently affected shoulder; 3 primary osteoarthritis of the glenohumeral joint in a simple radiograph; 4previous injection history at the affected shoulder within 3 months
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients with rotator cuff disorders
Arm Description
patients with rotator cuff disorders, including impingment, rotator cuff disorders and rotator cuff tear receiving hyaluronic acid injection over subacromial bursa
Outcomes
Primary Outcome Measures
constant shoulder score
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 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 measured by visual analog scale
pain intensity was measured by visual analog scale. the total score ranges from 0 to 10 points, with higher scores indicative of more painful
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
NCT03677895
First Posted
September 9, 2018
Last Updated
October 8, 2018
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT03677895
Brief Title
What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection
Official Title
What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 8, 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the correlations between structure of supraspinatus tendon (impingement, tendinopathy or partial tear, as well as full thickness tear) on ultrasonography and its response to subacromial hyaluronic acid injection in rotator cuff disease patients
Detailed Description
Objective: To evaluate the correlations between structure of supraspinatus tendon (impingement, tendinopathy or partial tear, as well as full thickness tear) on ultrasonography and its response to subacromial hyaluronic acid injection in rotator cuff disease patients and also investigate the factors associated with clinically important improvement after subdeltoid hyaluronic acid for rotator cuff disorder.
Design: Prospective, longitudinal comparison study.
Participants: Patients with rotator cuff disease
Intervention: Three subacromial injection with hyaluronic acid with 2 week-interval.
Main Outcome Measures: Visual analog scale (VAS) of the shoulder pain, Constant score, SPADI score, and angles of active shoulder range of motion (flexion, abduction, external rotation, and internal rotation) at pre-treatment, post-treatment at week 4 and post-treatment at week 12.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Impingement Syndrome
Keywords
rotator cuff disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients with rotator cuff disorders receving subacromial hyaluronic acid injection
Masking
None (Open Label)
Masking Description
outcome assessor does not know the rotator cuff condition of patients
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with rotator cuff disorders
Arm Type
Experimental
Arm Description
patients with rotator cuff disorders, including impingment, rotator cuff disorders and rotator cuff tear receiving hyaluronic acid injection over subacromial bursa
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid
Other Intervention Name(s)
hyruan
Intervention Description
Hyaluronic Acid 2cc into subacromial bursa at weeks 0, 2 and 4
Primary Outcome Measure Information:
Title
constant shoulder score
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 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
12 weeks
Secondary Outcome Measure Information:
Title
pain intensity measured by visual analog scale
Description
pain intensity was measured by visual analog scale. the total score ranges from 0 to 10 points, with higher scores indicative of more painful
Time Frame
0, 6, 12 weeks
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, 6, 12 weeks
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, 6, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria were patients
with clinically and ultrasonographically diagnosed rotator cuff disease of the shoulder-impingement, tendinosis and tear;
who reported shoulder pain more than 3 months;
Exclusion Criteria:
presence of another medical or psychological condition, including cancer, rheumatoid arthritis, endocrine disease (i.e., diabetes), major depression, or schizophrenia;
previous major trauma history at currently affected shoulder; 3 primary osteoarthritis of the glenohumeral joint in a simple radiograph; 4previous injection history at the affected shoulder within 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Chi Wang, MD
Phone
886-2-28757361
Email
jcwang0726@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Chi Wang, MD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia chi c Wang, MD
Phone
886-2-28757361
Email
jcwang0726@gmail.com
12. IPD Sharing Statement
Learn more about this trial
What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection
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