Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of intra-articular steroid injection, sodium hyaluronate injection, a combination of the two, and placebo in the treatment of adhesive capsulitis of the shoulder.

Official Title
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Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis: A Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Adhesive Capsulitis

Intervention / Treatment
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* Procedure: isotonic saline injection into the glenohumeral joint
* Procedure: steroid injection into the glenohumeral joint
* Procedure: sodium hyaluronate injection into the glenohumeral joint
* Procedure: steroid and hyaluronate injection into the glenohumeral joint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis : Adhesive Capsulitis of the Shoulder defining of adhesive capsulitis the presence of shoulder pain limitation of both active and passive movements of the glenohumeral joint of ≥25% in at list 2 directions(abduction,flexion,external rotation,internal rotation), as compared with the contralateral shoulder duration : symptomatic for < 1 year Exclusion Criteria: bilateral symptoms uncontrolled diabetes mellitus overt hypothyroidism or hyperthyroidism previous shoulder surgery previous glenohumeral joint injection within recent 6months trauma to the shoulder the last six months that required hospital care neurological symptoms allergy to injection material secondary adhesive capsulitis systemic inflammatory ds including rheumatoid arthritis degenerative arthritis of shoulder joint infectious arthritis of shoulder joint dislocation of shoulder joint blood coagulation disease rotator cuff tear serious mental illness pregnancy fracture in shoulder lesion CVA

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Isotonic saline<br> | Procedure: isotonic saline injection into the glenohumeral joint<br>* Total volume of injection drugs: 8ml isotonic saline 4ml + telebrix(contrast media) 4ml The number of injections : only once during the study period Injection site : glenohumeral joint Material : 22-gauze spinal needle Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.<br>|
| Experimental: Steroid<br> | Procedure: steroid injection into the glenohumeral joint<br>* Total volume of injection drugs: 8ml triamcinolone(40mg)1ml + isotonic saline 3ml + telebrix(contrast media)4ml The number of injections : only once during the study period Injection Site : glenohumeral joint Material : 22-gauze spinal needle Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.<br>|
| Experimental: Hyaluronate<br> | Procedure: sodium hyaluronate injection into the glenohumeral joint<br>* Total volume of injection drugs: 8ml sodium hyaluronate 2ml + isotonic saline 2ml + telebrix(contrast media)4ml The number of injections : only once during the study period Injection Site : glenohumeral joint Material : 22-gauze spinal needle Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.<br>|
| Experimental: Steroid + Hyaluronate<br> | Procedure: steroid and hyaluronate injection into the glenohumeral joint<br>* Total volume of injection drugs: 8ml triamcinolone(40mg)1ml + sodium hyaluronate 2ml + isotonic saline 1ml + telebrix(contrast media)4ml The number of injections : only once during the study period Injection Site : glenohumeral joint Material : 22-gauze spinal needle Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPADI Score (Shoulder Pain and Disability Index) |  | Postinjection 1month |