Status:
COMPLETED
Intra-articular Injection of Allogeneic Platelet Rich Plasma (PRP) for Adhesive Capsulitis
Lead Sponsor:
Seoul National University Hospital
Conditions:
Adhesive Capsulitis
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2015
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01458691
Start Date
September 1 2013
End Date
October 20 2015
Last Update
October 8 2020
Active Locations (1)
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1
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, South Korea