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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
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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

Condition or disease Intervention/treatment Phase
Rotator Cuff Impingement Syndrome Drug: Hyaluronic Acid Not Applicable

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.


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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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria were patients

  1. with clinically and ultrasonographically diagnosed rotator cuff disease of the shoulder—impingement, tendinosis and tear;
  2. who reported shoulder pain more than 3 months;

Exclusion Criteria:

  1. presence of another medical or psychological condition, including cancer, rheumatoid arthritis, endocrine disease (i.e., diabetes), major depression, or schizophrenia;
  2. 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

Information from the National Library of Medicine

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


Contacts
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Contact: Jia Chi Wang, MD 886-2-28757361 jcwang0726@gmail.com

Locations
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Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Jia chi c Wang, MD    886-2-28757361    jcwang0726@gmail.com   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Study Director: Jia Chi Wang, MD Taipei Veterans General Hospital, Taiwan

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03677895     History of Changes
Other Study ID Numbers: 2017-02-006C
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
rotator cuff disorder
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Shoulder Injuries
Wounds and Injuries
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents