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

Not Applicable

• Conditions: Adhesive Capsulitis
• Interventions: Drug: Steroid (shincort)

• Registration Number: NCT03622853
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-03-29
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-07
• Last Update Submitted: 2018-08-07
• Study First Posted: 2018-08-09
• Last Update Posted: 2018-08-09
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intraarticular steroid injection	Steroid (shincort)	intraarticular steroid hydrodilatation (shincort 40mg )

Primary Outcome Measures

Name	Time	Method
The change of constant shoulder score between week 0 and week 8	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

Secondary Outcome Measures

Name	Time	Method
Shoulder Pain And disability index	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.
glenohumeral joint range of motion	0 and 8 wks	Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position
pain intensity	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.

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan