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

Seoul National University

Status: Completed

Conditions: Adhesive Capsulitis

Treatments: Procedure: Steroid injection into the glenohumeral joint; Procedure: Allogeneic PRP injection into the glenohumeral joint

Study type: Interventional

Funder types: Other

Identifiers

NCT01458691

BRM-11-02

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

58 participants in 2 patient groups

Steroid group

Active Comparator group

Description:

Triamcinolone injection group

Treatment:

Procedure: Steroid injection into the glenohumeral joint

PRP group

Experimental group

Description:

Allogeneic PRP injection group

Treatment:

Procedure: Allogeneic PRP injection into the glenohumeral joint