What Factors Area Associated With Prognosis After Steroid... | NCT03622853

Studies
What Factors Area Associated With Prognosis After Steroid Hydrodilatation for Adhesive Capsulitis

NCT03622853

Sponsor

Taipei Veterans General Hospital, Taiwan

Status

Unknown status

Last Update Posted

Aug 9, 2018Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Adhesive Capsulitis

Interventions

Steroid (shincort)

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Mar 1, 2019Estimated

Completion Date

Mar 1, 2019Estimated

First Submitted Date

Mar 29, 2018

First Submission Date that Met QC Criteria

Aug 7, 2018

First Posted Date

Aug 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2018

Last Update Posted Date

Aug 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design: Prospective study.

Participants: Patients with Frozen shoulder were recorded the demographic data, associated disease, ultrasound findings at baselines.

Intervention: One shot intraarticular steroid hydrodilatation

Main Outcome Measures: Visual analog scale (VAS) of the shoulder pain, Constant score, SPADI score, and angles of active and passive shoulder range of motion (flexion, abduction, external rotation, and internal rotation) at pre-treatment, post-treatment at week 8

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intraarticular steroid injection	Experimental	intraarticular steroid hydrodilatation (shincort 40mg )	Drug: Steroid (shincort)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Steroid (shincort)	Drug	intraarticular shincort 40mg / 4ml mixed with 2% xylocaine and Normal saline	intraarticular steroid injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
pain intensity	pain intensity was measured by visual analog scale. Each patient was asked to indicate his/her current level of pain by marking a point on a 100-mm VAS, for which 0 represented no pain and 100 represented unbearable pain.	0 and 8 wks
Shoulder Pain And disability index

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of frozen shoulder by physical examination and ultrasonography

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jia chi c Wang, MD	Contact	919527693		jcwang0726@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Veterans General Hospital	Recruiting	Taipei		241	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002062	Bursitis

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013256	Steroids

Ancestor Terms

ID	Term
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided