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

NCT03677895 | Unknown

• 1 other identifier: 2017-02-006C
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Rotator Cuff Impingement Syndrome

Keywords

rotator cuff disorder

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (3)

• pain intensity measured by visual analog scale

  0, 6, 12 weeks

• Shoulder Pain And disability index

  0, 6, 12 weeks

• glenohumeral joint range of motion

  0, 6, 12 weeks

Study Arms (1)

patients with rotator cuff disorders

EXPERIMENTAL

patients with rotator cuff disorders, including impingment, rotator cuff disorders and rotator cuff tear receiving hyaluronic acid injection over subacromial bursa

Drug: Hyaluronic Acid

Interventions

Hyaluronic Acid DRUG

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

Also known as: hyruan

patients with rotator cuff disorders

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with clinically and ultrasonographically diagnosed rotator cuff disease of the shoulder-impingement, tendinosis and tear;
• who reported shoulder pain more than 3 months;

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Jia Chi Wang, MD

  Taipei Veterans General Hospital, Taiwan

  STUDY DIRECTOR

Central Study Contacts

Jia Chi Wang, MD

CONTACT

886-2-28757361; jcwang0726@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: outcome assessor does not know the rotator cuff condition of patients
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: patients with rotator cuff disorders receving subacromial hyaluronic acid injection

Study Record Dates

• First Submitted: September 9, 2018
• First Posted: September 19, 2018
• Study Start: October 8, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

TW (1)