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

Taipei Veterans General Hospital, Taiwan84 enrolled

Overview

This study was conducted to compare the efficacy of hydrodilatation with steroid with hyaluronic acid and steroid for treating adhesive capsulitis.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Adhesive Capsulitis

Interventions

normal salineDRUG

Ultrasound guided injection using 3ml normal saline

(Sodium Hyaluronate (Hyruan One , LG)DRUG

Ultrasound guided injection using 3ml of Sodium Hyaluronate

lidocaine hydrochlorideDRUG

Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

change in pain intensity

pain intensity was measured by visual analog scale (0-10)

Time frame: 0, 6, 12weeks

Secondary Outcomes

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.

Time frame: 0, 6, 12 weeks

change in glenohumeral joint range of motion

Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.

Time frame: 0, 6, 12weeks

Central Contacts

Jia chi wang

CONTACT

0919527693 jcwang0726@gmail.com

Data from ClinicalTrials.gov

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