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

Taipei Veterans General Hospital, Taiwan200 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Rotator Cuff Impingement Syndrome

Interventions

Hyaluronic AcidDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 0, 6, 12 weeks

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.

Time frame: 0, 6, 12 weeks

glenohumeral joint range of motion

Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position

Time frame: 0, 6, 12 weeks

Central Contacts

Jia Chi Wang, MD

CONTACT

886-2-28757361 jcwang0726@gmail.com

Data from ClinicalTrials.gov

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