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

Overview

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.

Full Title of Study: “Intra-articular Injection of Allogeneic PRP for Adhesive Capsulitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 2015

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Steroid group
    • Triamcinolone injection group
  • Experimental: PRP group
    • Allogeneic PRP injection group

Clinical Trial Outcome Measures

Primary Measures

  • SPADI(Shoulder Pain and Disability Index)Score
    • Time Frame: Postinjection 1month
    • 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.
  • Safety determined with symptoms & signs of infection and immune response and adverse events evaluated with NCI-CTCAE v3.0
    • Time Frame: Postinjection 1month
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hyunchul Jo, Associate Professor, SMG-SNU Boramae Medical Center – Seoul National University Hospital
  • Overall Official(s)
    • Chris H. Jo, M.D., Ph.D, Principal Investigator, Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

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