Steroid Injection for 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 low dose steroid with high dose 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 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

Official Title
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Comparing Low Dose and High Dose Steroid Injection for Adhesive Capsulitis

Conditions
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Adhesive Capsulitis

Intervention / Treatment
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* Drug: Triamcinolone Acetonide
* Drug: lidocaine hydrochloride
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of adhesive capsulitis a duration of complaints more than 3 months 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: prior manipulation of the affected shoulder under anesthesia; other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region); neurologic deficits affecting shoulder function in normal daily activities; shoulder pain caused by cervical radiculopathy a history of drug allergy to hyaluronic acid; pregnancy or lactation; received injection into the affected shoulder during the preceding 3 months

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 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: low dose steroid<br>patient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS | Drug: Triamcinolone Acetonide<br>* ultrasound guided steroid injection using 1ml of 10mg or 4ml of 40mg triamcinolone acetonide<br>* Other names: triamcinolone acetonide 10mg/ml (Shincort, YSP, Taiwan);Drug: lidocaine hydrochloride<br>* Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)<br>* Other names: lidocaine hydrochloride (Xylocaine);Drug: Normal saline<br>* Ultrasound guided injection using 15ml or 12 ml of normal saline<br>|
| Active Comparator: high dose steroid<br>patient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS | Drug: Triamcinolone Acetonide<br>* ultrasound guided steroid injection using 1ml of 10mg or 4ml of 40mg triamcinolone acetonide<br>* Other names: triamcinolone acetonide 10mg/ml (Shincort, YSP, Taiwan);Drug: lidocaine hydrochloride<br>* Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)<br>* Other names: lidocaine hydrochloride (Xylocaine);Drug: Normal saline<br>* Ultrasound guided injection using 15ml or 12 ml of normal saline<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, 12 wks. | 

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 wks. | 
| 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. |