Intra-articular Injection of Allogeneic Platelet Rich Plasma (PRP) for 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 allogenic Platelet Rich Plasma injection and steroid injection in the treatment of adhesive capsulitis of the shoulder.

Official Title
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Intra-articular Injection of Allogeneic PRP for Adhesive Capsulitis

Conditions
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Adhesive Capsulitis

Intervention / Treatment
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* Procedure: Steroid injection into the glenohumeral joint
* Procedure: Allogeneic PRP injection into the glenohumeral joint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age and older Patients who have had pain at least for 12 months 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 in the scapular plane and in progressive degree of horizontal adduction Exclusion Criteria: Patients with concurrent bilateral shoulder pain Patients with Diabetes mellitus Patient with overt hypothyroidism or hyperthyroidism Patients who received any drug by intra-articular injection for treatment within 6 months prior to this enrollment. Patients who have a history of shoulder trauma including dislocation- subluxation- and fracture- breast cancer- or surgery around shoulder- neck and upper back Patients with neurological deficit Patients who have a History of allergic adverse reactions to corticosteroid Patients with secondary adhesive capsulitis Patients with systemic inflammatory disease including rheumatoid arthritis Patients with degenerative arthritis, infectious arthritis of shoulder joint Patients who have a history of shoulder trauma including dislocation, fracture Patients taking anticoagulants Patients who have a full-thickness rotator cuff tear Patients who are difficulty participating in data collection due to communication problem and serious mental illness Pregnant women or lactating mothers Patients with cerebrovascular accident Patients with symptomatic cervical spine disorders Patients with serious condition which can affect this study such as severe cardiovascular diseases- renal diseases- liver diseases- endocrine diseases- and cancers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid group<br>Triamcinolone injection group | Procedure: Steroid injection into the glenohumeral joint<br>* Group: Steroid Total volume of injection drugs: 4ml(1ml of triamcinolone acetonide 40mg/ml + 3ml of 2% lidocaine) The number of injections : only once during the study period Injection site : glenohumeral joint Material : 25-gauze spinal needle The intra-articular injections were performed using ultrasonographic guidance.<br>|
| Experimental: PRP group<br>Allogeneic PRP injection group | Procedure: Allogeneic PRP injection into the glenohumeral joint<br>* Group: Allogeneic PRP Total volume of injection drugs: 4ml The number of injections : only once during the study period Injection site : glenohumeral joint Material : 25-gauze spinal needle The intra-articular injections were performed using ultrasonographic guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPADI(Shoulder Pain and Disability Index)Score | 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. | Postinjection 1month | 
| Safety determined with symptoms & signs of infection and immune response and adverse events evaluated with NCI-CTCAE v3.0 | Presence of general symptoms or signs associated with infection and immune response, such as rash, pruritus, fever, chills, urticaria, or dyspnea. Injection sites were examined to identify erythema, swelling, or abnormal discharge. Adverse events were categorised with use of the National Cancer Institute Common Terminology Criteria for Adverse Events scale, version 3.0. | Postinjection 1month |