What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection

NCT ID: NCT03677895

Last Updated: 2018-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-08

Study Completion Date

2019-03-01

Brief Summary

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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

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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.

Conditions

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Rotator Cuff Impingement Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

patients with rotator cuff disorders receving subacromial hyaluronic acid injection
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

outcome assessor does not know the rotator cuff condition of patients

Study Groups

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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

Group Type EXPERIMENTAL

Hyaluronic Acid

Intervention Type DRUG

Hyaluronic Acid 2cc into subacromial bursa at weeks 0, 2 and 4

Interventions

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Hyaluronic Acid

Hyaluronic Acid 2cc into subacromial bursa at weeks 0, 2 and 4

Intervention Type DRUG

Other Intervention Names

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hyruan

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jia Chi Wang, MD

Role: STUDY_DIRECTOR

Taipei Veterans General Hospital, Taiwan

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jia Chi Wang, MD

Role: CONTACT

886-2-28757361

Facility Contacts

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Jia chi c Wang, MD

Role: primary

886-2-28757361

Other Identifiers

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2017-02-006C

Identifier Type: -

Identifier Source: org_study_id

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