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

Adhesive Capsulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03622853
• Other study ID #: 2017-02-005c
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: August 2018
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Jia chi c Wang, MD
• Phone: 919527693
• Email: jcwang0726[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Drug:
• Steroid (shincort)
intraarticular shincort 40mg / 4ml mixed with 2% xylocaine and Normal saline

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Shoulder Pain And disability index	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
Secondary	glenohumeral joint range of motion	Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position	0 and 8 wks