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

Rotator Cuff Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04461522
• Other study ID #: M20191203
• Status: Recruiting
• Start date: March 10, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2020
• Source: Peking University Third Hospital
• Contact: Mouwang Zhou, Doctor
• Phone: 13910092892
• Email: zhoumouwang[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder function	VAS	Beginning
Primary	Shoulder function	VAS	1 week
Primary	Shoulder function	VAS	1 month
Primary	Shoulder function	VAS	3months
Primary	Shoulder function	VAS	6 months
Primary	Shoulder function	ROM	Beginning
Primary	Shoulder function	ROM	1 week
Primary	Shoulder function	ROM	1 month
Primary	Shoulder function	ROM	3months
Primary	Shoulder function	ROM	6 months
Primary	Shoulder function	Constant Test	Beginning
Primary	Shoulder function	Constant Test	1 week
Primary	Shoulder function	Constant Test	1 month
Primary	Shoulder function	Constant Test	3months
Primary	Shoulder function	Constant Test	6 months