Steroid Injection for Adhesive Capsulitis

Adhesive Capsulitis Clinical Trial

Official title:

Comparing Low Dose and High Dose Steroid Injection for Adhesive Capsulitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04364425
• Other study ID #: 2019-07-005C
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2020
• Est. completion date: September 2021

Study information

• Verified date: May 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Jia chi Wang
• Phone: 0919527693
• Email: jcwang0726[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to compare the efficacy of hydrodilatation with low dose steroid with high dose steroid for treating adhesive capsulitis.

Description:

Design: a prospective, double-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with low dose steroid ) and group 2 (hydrodilatation with high dose steroid). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Constant shoulder score, Shoulder Pain And Disability Index

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

1. clinical diagnosis of adhesive capsulitis

2. a duration of complaints more than 3 months

3. a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.

Exclusion Criteria:

1. prior manipulation of the affected shoulder under anesthesia;

2. other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);

3. neurologic deficits affecting shoulder function in normal daily activities;

4. shoulder pain caused by cervical radiculopathy

5. a history of drug allergy to hyaluronic acid;

6. pregnancy or lactation;

7. received injection into the affected shoulder during the preceding 3 months

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Drug:
• Triamcinolone Acetonide
ultrasound guided steroid injection using 1ml of 10mg or 4ml of 40mg triamcinolone acetonide
• lidocaine hydrochloride
Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)
• Normal saline
Ultrasound guided injection using 15ml or 12 ml of normal saline

Locations

Country	Name	City	State
Taiwan	Taipei veteran 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	change in pain intensity	pain intensity was measured by visual analog scale (0-10)	0, 6, 12 wks.
Secondary	change in 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, 6, 12 wks.
Secondary	change in glenohumeral joint range of motion	Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.	0, 6, 12 wks.