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

August 7, 2018 updated by: Taipei Veterans General Hospital, Taiwan
To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 241
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of frozen shoulder by physical examination and ultrasonography

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intraarticular steroid injection
intraarticular steroid hydrodilatation (shincort 40mg )
Drug: Steroid (shincort)
intraarticular shincort 40mg / 4ml mixed with 2% xylocaine and Normal saline
Other Names:
  • shincort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of constant shoulder score between week 0 and week 8
Time Frame: 0 and 8 wks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: 0 and 8 wks
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
Time Frame: 0 and 8 wks
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
0 and 8 wks
glenohumeral joint range of motion
Time Frame: 0 and 8 wks
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position
0 and 8 wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

March 29, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-02-005c

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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