Comparison of Different Volume of 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 low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis

Detailed Description
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adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance 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 (10cc steroid hydrodilatation under ultrasonographic guidance ) and group 2 (20cc steroid hydrodilatation). 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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Comparison of Different Volume of Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

Conditions
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Adhesive Capsulitis

Intervention / Treatment
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* Drug: steroid
* Drug: Xylocaine 2 % Injectable Solution
* Drug: Normal saline 2cc
* Drug: normal saline 12cc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) age 35-65 years (to prevent the inclusion of patients with secondary AC), 2) onset of shoulder stiffness since over a month, and 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: 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, and 8) 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: low volume hydrodilatation<br>patient received ultrasound-guided low volume steroid hydrodilatation (4cc shincort + 4cc 2% xylocaine +2cc normal saline) | Drug: steroid<br>* triamcinolone 40mg 4cc<br>Drug: Xylocaine 2 % Injectable Solution<br>* xylocaine 2% 4cc<br>Drug: Normal saline 2cc<br>* normal saline 2cc<br>|
| Active Comparator: high volume hydrodilatation<br>patient received ultrasound-guided high volume steroid hydrodilatation (4cc shincort + 4cc 2% xylocaine +12cc normal saline) | Drug: steroid<br>* triamcinolone 40mg 4cc<br>Drug: Xylocaine 2 % Injectable Solution<br>* xylocaine 2% 4cc<br>Drug: normal saline 12cc<br>* normal saline 12cc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in visual analog scale visual analog scale | visual analog scale | at 6, 12 wk | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in glenohumeral joint range of motion | Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position. | at 6, 12 wk | 
| 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. | at 6, 12 wk | 
| change in pain intensity | pain intensity was measured by visual analog scale. | at 6, 12 wk | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adhesive capsulitis