Subacromial Injection of Allogeneic Platelet Rich Plasma (PRP) for Shoulder Impingement Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Hyunchul Jo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02019537
First received: December 18, 2013
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to investigate the efficacy of allogeneic PRP in patients with subacromial impingement disease


Condition Intervention
Shoulder Impingement Syndrome
Procedure: Steroid injection into the subacromial space
Procedure: Allogeneic PRP injection into the subacromial space

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Constant-Murley score [ Time Frame: Postinjection 1month ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Steroid group
Triamcinolone injection group
Procedure: Steroid injection into the subacromial space
  • 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 : subacromial space
  • Material : 25-gauze spinal needle
  • Subacromial injections were performed using ultrasonographic guidance.
Experimental: PRP group
Allogeneic PRP injection group
Procedure: Allogeneic PRP injection into the subacromial space
  • Group: Allogeneic PRP
  • Total volume of injection drugs: 4ml
  • The number of injections : only once during the study period
  • Injection site : subacromial space
  • Material : 25-gauze spinal needle
  • Subacromial 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:

  • Unilateral shoulder pain
  • Symptomatic for > 3months
  • To be included in the study, participants are required to have a & b.(mentioned below)
  • a. Pain with one of the two tests

    • Neer's sign: passive overpressure at full shoulder flexion with the scapula stabilised
    • Hawkins test: passive internal rotation at 90 degree of shoulder flexion in the scapular plane and in progressive degree of horizontal adduction
  • b. Pain with one of the two tests

    • Painful arc: active shoulder abduction
    • Jobe's test: The examiner passively elevates the patient's shoulder to 90 degrees of abduction with internal rotation. The examiner then applies a downward pressure against the arm

Exclusion Criteria:

  • Previous subacromial injection in past 3 months
  • History of shoulder dislocation, subluxation, fracture, breast cancer, cervical/shoulder/upper back surgery
  • Isolated acromioclavicular joint pathology
  • Full-thickness rotator cuff tears (evidenced by MR or ultrasonography)
  • Symptomatic cervical spine disorders
  • History of allergic adverse reactions to corticosteroid
  • Unable to give informed consent to participate in the study
  • Unable to come into the clinic for regular treatment over the course of the following month
  • Known or suspected polyarthritis, infectious arthritis, rheumatoid arthritis or diagnosed fibromyalgia
  • Concurrent bilateral shoulder pain
  • Neurological abnormality
  • Radiological findings: malignancy, osteoarthritis of the glenohumeral joint, skeletal abnormalities decreasing the subacromial space
  • Presence of shoulder pain with limitation of both active and passive movements of the glenohumeral joint of 25% in at least 2 directions (abduction, flexion, external rotation, internal rotation), as compared with the contralateral shoulder or with normal values
  • Diabetes mellitus
  • Patients taking anticoagulants
  • Pregnant, breastfeeding mothers
  • Difficulty participating in data collection due to communication problem, serious mental illness
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019537

Contacts
Contact: Ji Sun Shin shinjs11@gmail.com

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, 156-707
Contact: Ji Sun Shin       shinjs11@gmail.com   
Principal Investigator: Chris Hyunchul Jo, M.D., Ph.D         
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Hyunchul Jo, Associate Professor, SMG-SNU Boramae Medical Center, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02019537     History of Changes
Other Study ID Numbers: BRM-13-01
Study First Received: December 18, 2013
Last Updated: January 29, 2014
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 22, 2014