Adhesive Capsulitis Clinical Trial
Official title:
Intra-articular Injection of Allogeneic PRP for Adhesive Capsulitis
Verified date | May 2015 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | October 20, 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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