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

NCT ID: NCT01458691

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-10-20

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.

Conditions

Adhesive Capsulitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Steroid group

Triamcinolone injection group

Group Type: ACTIVE_COMPARATOR

Steroid injection into the glenohumeral joint

Intervention Type: PROCEDURE

• 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.

PRP group

Allogeneic PRP injection group

Group Type: EXPERIMENTAL

Allogeneic PRP injection into the glenohumeral joint

Intervention Type: PROCEDURE

• 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyunchul Jo

Associate Professor, SMG-SNU Boramae Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris H. Jo, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

Locations

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BRM-11-02

Identifier Type: -

Identifier Source: org_study_id