Is Combined Steroid and Sodium Hyaluronate Hydrodilatation More Effective Than Isolated Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

Adhesive Capsulitis Clinical Trial

Official title:

Steroid and Sodium Hyaluronate Hydrodilatation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861570
• Other study ID #: 2022-01-001B
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2023
• Est. completion date: April 6, 2024

Study information

• Verified date: April 2023
• 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 steroid with hyaluronic acid and 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 steroid ) and group 2 (hydrodilatation with hyaluronic acid and 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, Shoulder Pain And Disability Index

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: April 6, 2024
• Est. primary completion date: April 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

1. age 35-65 years

2. onset of shoulder stiffness since over a month

3. limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation.

Exclusion Criteria:

1. ultrasound findings of rotator cuff tears,

2. plain radiography findings of significant glenohumeral joint arthritis,

3. accompanying cervical radiculopathy,

4. systemic inflammatory joint disease,

5. intraarticular injection into the glenohumeral joint within the past 3 months

6. history of surgery on the affected shoulders,

7. regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids,

8. allergy to corticosteroid or lidocaine.

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Drug:
• normal saline
Ultrasound guided injection using 3ml normal saline
• (Sodium Hyaluronate (Hyruan One , LG)
Ultrasound guided injection using 3ml of Sodium Hyaluronate
• lidocaine hydrochloride
Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)
• Triamcinolone Acetonide
ultrasound guided steroid injection using 4ml of 40mg triamcinolone acetonide

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei City

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, 12weeks
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 weeks
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, 12weeks