NCT03622853

Brief Summary

To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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

January 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

March 29, 2018

Last Update Submit

August 7, 2018

Conditions

Adhesive Capsulitis

Keywords

adhesive capsulitis

Outcome Measures

Primary Outcomes (1)

  • The change of constant shoulder score between week 0 and week 8

    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

    0 and 8 wks

Secondary Outcomes (3)

  • pain intensity

    0 and 8 wks

  • Shoulder Pain And disability index

    0 and 8 wks

  • glenohumeral joint range of motion

    0 and 8 wks

Study Arms (1)

intraarticular steroid injection

EXPERIMENTAL

intraarticular steroid hydrodilatation (shincort 40mg )

Drug: Steroid (shincort)

Interventions

Steroid (shincort)DRUG

intraarticular shincort 40mg / 4ml mixed with 2% xylocaine and Normal saline

Also known as: shincort
intraarticular steroid injection

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of frozen shoulder by physical examination and ultrasonography

You may not qualify if:

  • other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region);
  • neurologic deficits affecting shoulder function in normal daily activities;
  • shoulder pain caused by cervical radiculopathy
  • a history of drug allergy to xylocaine
  • pregnancy or lactation;
  • received injection into the affected shoulder during the preceding 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 241, Taiwan

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Steroids

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Jia chi c Wang, MD

CONTACT

919527693jcwang0726@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2018

First Posted

August 9, 2018

Study Start

January 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)