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

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

Detailed Description
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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

Official Title
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Steroid and Sodium Hyaluronate Hydrodilatation

Conditions
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Adhesive Capsulitis

Intervention / Treatment
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* Drug: normal saline
* Drug: (Sodium Hyaluronate (Hyruan One , LG)
* Drug: lidocaine hydrochloride
* Drug: Triamcinolone Acetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 35-65 years onset of shoulder stiffness since over a month 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: ultrasound findings of rotator cuff tears, plain radiography findings of significant glenohumeral joint arthritis, accompanying cervical radiculopathy, systemic inflammatory joint disease, intraarticular injection into the glenohumeral joint within the past 3 months history of surgery on the affected shoulders, regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids, allergy to corticosteroid or lidocaine.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydrodilatation with steroid<br>patient received ultrasound-guided 3cc NS + 40mg triamcinolone + 4cc xylocaine | Drug: normal saline<br>* Ultrasound guided injection using 3ml normal saline<br>Drug: lidocaine hydrochloride<br>* Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)<br>Drug: Triamcinolone Acetonide<br>* ultrasound guided steroid injection using 4ml of 40mg triamcinolone acetonide<br>|
| Active Comparator: hydrodilatation with hyaluronic acid and steroid<br>patient received ultrasound-guided 3cc hyaluronic acid + 40mg triamcinolone + 4cc xylocaine | Drug: (Sodium Hyaluronate (Hyruan One , LG)<br>* Ultrasound guided injection using 3ml of Sodium Hyaluronate<br>Drug: lidocaine hydrochloride<br>* Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)<br>Drug: Triamcinolone Acetonide<br>* ultrasound guided steroid injection using 4ml of 40mg triamcinolone acetonide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in pain intensity | pain intensity was measured by visual analog scale (0-10) | 0, 6, 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |