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

Adhesive Capsulitis Clinical Trial

Official title:

Intra-articular Injection of Allogeneic PRP for Adhesive Capsulitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458691
• Other study ID #: BRM-11-02
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: October 20, 2015

Study information

• Verified date: May 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Procedure:
• Steroid injection into the glenohumeral joint
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.
• Allogeneic PRP injection into the glenohumeral joint
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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