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

Intra-articular Injection of Allogeneic PRP for Adhesive Capsulitis

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.

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis
• Intervention / Treatment: Procedure: Steroid injection into the glenohumeral joint; Procedure: Allogeneic PRP injection into the glenohumeral joint

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Steroid group; Triamcinolone injection group	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.
Experimental: PRP group; Allogeneic PRP injection group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): October 20, 2015

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: October 24, 2011
• First Posted (Estimate): October 25, 2011

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: BRM-11-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No