Intra-articular Injection of Allogeneic Platelet Rich Plasma (PRP) for Adhesive Capsulitis

Not Applicable

Completed

• Conditions: Adhesive Capsulitis
• Interventions: Procedure: Steroid injection into the glenohumeral joint; Procedure: Allogeneic PRP injection into the glenohumeral joint

• Registration Number: NCT01458691
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-25
• Study Start: 2013-09
• Primary Completion: 2015-03
• Status Verified: 2015-05
• Study Completion: 2015-10-20
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Male or female 18 years of age and older
2. Patients who have had pain at least for 12 months
3. 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

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Exclusion Criteria

1. Patients with concurrent bilateral shoulder pain
2. Patients with Diabetes mellitus
3. Patient with overt hypothyroidism or hyperthyroidism
4. Patients who received any drug by intra-articular injection for treatment within 6 months prior to this enrollment.
5. Patients who have a history of shoulder trauma including dislocation- subluxation- and fracture- breast cancer- or surgery around shoulder- neck and upper back
6. Patients with neurological deficit
7. Patients who have a History of allergic adverse reactions to corticosteroid
8. Patients with secondary adhesive capsulitis
9. Patients with systemic inflammatory disease including rheumatoid arthritis
10. Patients with degenerative arthritis, infectious arthritis of shoulder joint
11. Patients who have a history of shoulder trauma including dislocation, fracture
12. Patients taking anticoagulants
13. Patients who have a full-thickness rotator cuff tear
14. Patients who are difficulty participating in data collection due to communication problem and serious mental illness
15. Pregnant women or lactating mothers
16. Patients with cerebrovascular accident
17. Patients with symptomatic cervical spine disorders
18. Patients with serious condition which can affect this study such as severe cardiovascular diseases- renal diseases- liver diseases- endocrine diseases- and cancers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid group	Steroid injection into the glenohumeral joint	Triamcinolone injection group
PRP group	Allogeneic PRP injection into the glenohumeral joint	Allogeneic PRP injection group

Primary Outcome Measures

Name	Time	Method
SPADI(Shoulder Pain and Disability Index)Score	Postinjection 1month	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.
Safety determined with symptoms & signs of infection and immune response and adverse events evaluated with NCI-CTCAE v3.0	Postinjection 1month	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.

Trial Locations

Locations (1)

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine; 🇰🇷 Seoul, Korea, Republic of