What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection
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|ClinicalTrials.gov Identifier: NCT03677895|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : October 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Impingement Syndrome||Drug: Hyaluronic Acid||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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|
|Official Title:||What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection|
|Actual Study Start Date :||October 8, 2018|
|Estimated Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||March 1, 2019|
Experimental: patients with rotator cuff disorders
patients with rotator cuff disorders, including impingment, rotator cuff disorders and rotator cuff tear receiving hyaluronic acid injection over subacromial bursa
Drug: Hyaluronic Acid
Hyaluronic Acid 2cc into subacromial bursa at weeks 0, 2 and 4
Other Name: hyruan
- constant shoulder score [ Time Frame: 12 weeks ]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
- pain intensity measured by visual analog scale [ Time Frame: 0, 6, 12 weeks ]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 [ Time Frame: 0, 6, 12 weeks ]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 [ Time Frame: 0, 6, 12 weeks ]Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677895
|Contact: Jia Chi Wang, MDemail@example.com|
|Taipei Veterans General Hospital||Recruiting|
|Taipei, Taiwan, 112|
|Contact: Jia chi c Wang, MD 886-2-28757361 firstname.lastname@example.org|
|Study Director:||Jia Chi Wang, MD||Taipei Veterans General Hospital, Taiwan|