Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03677895
Enrollment
200
Registered
2018-09-19
Start date
2018-10-08
Completion date
2019-03-01
Last updated
2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Impingement Syndrome

Keywords

rotator cuff disorder

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

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

DRUGHyaluronic Acid

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

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

outcome assessor does not know the rotator cuff condition of patients

Intervention model description

patients with rotator cuff disorders receving subacromial hyaluronic acid injection

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
constant shoulder score12 weeksthe 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

MeasureTime frameDescription
pain intensity measured by visual analog scale0, 6, 12 weekspain 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 index0, 6, 12 weeksThe 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 motion0, 6, 12 weeksShoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position

Countries

Taiwan

Contacts

Primary ContactJia Chi Wang, MD
jcwang0726@gmail.com886-2-28757361

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026