Study on the Outcome of Treatment of Rotator Cuff Injury by Ultrasound-guided Injection

Prospective Cohort Study on the Outcome of Treatment of Rotator Cuff Injury by Ultrasound-guided

Rotator cuff injury is a common shoulder joint disease in clinic. If conservative treatment fails to improve pain symptoms and range of motion, the surgical indications are. Numerous studies have shown that the pain of rotator cuff injury usually comes not from the broken tendon, but from periarthritis tendonitis, bursitis or adhesive shoulder capsule, etc. Ultrasound-guided drug injection combined with conventional rehabilitation treatment can significantly improve the pain symptoms and increase joint mobility. This study intends to use prospective cohort study methods, exposed factors for ultrasound-guided injection drug treatment, establish a rotator cuff injury exposure group and the control group of shoulder joint dysfunction queue, whether of ultrasound guided drug injection therapy can increase the shoulder joint function analysis, and explore for the rotator cuff injury method provides the basis of the evidence-based conservative treatment. The establishment of a conservative treatment cohort for rotator cuff injury will also lay the foundation for the accurate rehabilitation treatment of rotator cuff injury.

Study Overview

• Status: Unknown
• Conditions: Rotator Cuff Injury
• Intervention / Treatment: Procedure: Ultrasound-guided drug injection

• Study Type: Observational
• Enrollment (Anticipated): 134

Contacts and Locations

• Study Contact: Name: Mouwang Zhou, Doctor; Phone Number: 13910092892; Email: zhoumouwang@163.com

Study Locations

• China
  • Beijing, China, 100191
    • Recruiting
    • Peking University Third Hospital
    • Contact: Mouwang Zhou, Doctor; Phone Number: 13910092892; Email: zhoumouwang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

He was admitted to the third hospital of Peking University due to the dysfunction of shoulder joint caused by rotator cuff injury

Description

Inclusion Criteria:

• Chief complaint around shoulder joint discomfort or restricted movement
• Nuclear magnetic or ultrasound in the diagnosis of rotator cuff injury and not to consider surgery patients
• Assessed by the musculoskeletal ultrasound images, diagnosed with tendonitis around shoulder joint, slippery bursa phlogistic or adhesive shoulder level
• Section capsule, such as indications of patients treated with ultrasound guided by injection.

Exclusion Criteria:

• History of shoulder fractures, open trauma, or surgery combined with shoulder and hand syndrome, gout, autoimmune arthritis, infectious arthritis, and other factors resulting in shoulder pain or limited mobility

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group
Exposed group	Procedure: Ultrasound-guided drug injection; The injection drugs were glucocorticoids and anesthetic drugs (1ml+2% lidocaine hydrochloride 0.5ml+0.9% sodium chloride 0.5ml), and the injection sites were subacromion deltoid bursa/coracoid bursa/biceps longhead tenosynosheath/glenohumeral joint bursa, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder function	VAS	Beginning
Shoulder function	VAS	1 week
Shoulder function	VAS	1 month
Shoulder function	VAS	3months
Shoulder function	VAS	6 months
Shoulder function	ROM	Beginning
Shoulder function	ROM	1 week
Shoulder function	ROM	1 month
Shoulder function	ROM	3months
Shoulder function	ROM	6 months
Shoulder function	Constant Test	Beginning
Shoulder function	Constant Test	1 week
Shoulder function	Constant Test	1 month
Shoulder function	Constant Test	3months
Shoulder function	Constant Test	6 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: rotator cuff injury; Ultrasound-guided drug injection
• Additional Relevant MeSH Terms: Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Wounds and Injuries
• Other Study ID Numbers: M20191203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No