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

NCT01458691 | Completed

• 1 other identifier: BRM-11-02
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Steroid group

ACTIVE COMPARATOR

Triamcinolone injection group

Procedure: Steroid injection into the glenohumeral joint

PRP group

EXPERIMENTAL

Allogeneic PRP injection group

Procedure: Allogeneic PRP injection into the glenohumeral joint

Interventions

Steroid injection into the glenohumeral joint 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.

Steroid group

Allogeneic PRP injection into the glenohumeral joint 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.

PRP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18 years of age and older
• Patients who have had pain at least for 12 months
• 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

You may not qualify if:

• Patients with concurrent bilateral shoulder pain
• Patients with Diabetes mellitus
• Patient with overt hypothyroidism or hyperthyroidism
• Patients who received any drug by intra-articular injection for treatment within 6 months prior to this enrollment.
• Patients who have a history of shoulder trauma including dislocation- subluxation- and fracture- breast cancer- or surgery around shoulder- neck and upper back
• Patients with neurological deficit
• Patients who have a History of allergic adverse reactions to corticosteroid
• Patients with secondary adhesive capsulitis
• Patients with systemic inflammatory disease including rheumatoid arthritis
• Patients with degenerative arthritis, infectious arthritis of shoulder joint
• Patients who have a history of shoulder trauma including dislocation, fracture
• Patients taking anticoagulants
• Patients who have a full-thickness rotator cuff tear
• Patients who are difficulty participating in data collection due to communication problem and serious mental illness
• Pregnant women or lactating mothers

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Chris H. Jo, M.D., Ph.D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, SMG-SNU Boramae Medical Center

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: October 25, 2011
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: October 20, 2015
• Last Updated: October 8, 2020

Record last verified: 2015-05

Locations

KR (1)