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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taipei Veterans General Hospital, Taiwan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jia Chi Wang, MD, Study Director, Taipei Veterans General Hospital, Taiwan
  • Overall Contact(s)
    • Jia Chi Wang, MD, 886-2-28757361, jcwang0726@gmail.com

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