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

This study is currently recruiting participants.
Verified December 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Hyunchul Jo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01458691
First received: October 21, 2011
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Adhesive Capsulitis
Procedure: Steroid injection into the glenohumeral joint
Procedure: Allogeneic PRP injection into the glenohumeral joint

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intra-articular Injection of Allogeneic PRP for Adhesive Capsulitis

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • SPADI(Shoulder Pain and Disability Index)Score [ Time Frame: Postinjection 1month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 58
Study Start Date: September 2013
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis : Adhesive Capsulitis of the Shoulder
  • defining of adhesive capsulitis

    • the presence of shoulder pain
    • 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
  • duration : symptomatic for < 1 year

Exclusion Criteria:

  • bilateral symptoms
  • diabetes mellitus
  • overt hypothyroidism or hyperthyroidism
  • previous shoulder surgery
  • previous glenohumeral joint injection within recent 6months
  • trauma to the shoulder the last six months that required hospital care
  • neurological symptoms
  • allergy to injection material
  • secondary adhesive capsulitis
  • systemic inflammatory ds including rheumatoid arthritis
  • degenerative arthritis of shoulder joint
  • infectious arthritis of shoulder joint
  • dislocation of shoulder joint
  • blood coagulation disease
  • rotator cuff tear
  • serious mental illness
  • pregnancy
  • fracture in shoulder lesion
  • CVA
  • Symptomatic cervical spine disorders
  • Patients with serious condition which can affect this study such as severe cardiovascular diseases, renal diseases, liver diseases, endocrine diseases, and cancers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458691

Locations
Korea, Republic of
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Ji Sun Shin       shinjs11@gmail.com   
Principal Investigator: Chris H. Jo, M.D., Ph.D         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Hyunchul Jo, Associate Professor, SMG-SNU Boramae Medical Center, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01458691     History of Changes
Other Study ID Numbers: BRM-11-02
Study First Received: October 21, 2011
Last Updated: December 18, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Bursitis
Periarthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis

ClinicalTrials.gov processed this record on April 14, 2014