NCT04461522

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

May 7, 2020

Last Update Submit

July 1, 2020

Conditions

Rotator Cuff Injury

Keywords

rotator cuff injuryUltrasound-guided drug injection

Outcome Measures

Primary Outcomes (15)

  • 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

Study Arms (2)

Exposed group

Procedure: Ultrasound-guided drug injection

Control group

Interventions

Ultrasound-guided drug injectionPROCEDURE

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.

Exposed group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Central Study Contacts

Mouwang Zhou, Doctor

CONTACT

13910092892zhoumouwang@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2020

First Posted

July 8, 2020

Study Start

March 10, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Locations

CN(1)