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

Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Shoulder Impingement Syndrome
• Intervention / Treatment: Procedure: Steroid injection into the subacromial space; Procedure: Allogeneic PRP injection into the subacromial space

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-707
    • 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:

• Male or female 18 years of age and older
• Patients who have unilateral shoulder pain.
• Patients who have had pain at least for 3 months

• To be included in the study- participants are required to have a & b.(mentioned below)

  1. Pain with one of the two tests

     • Neer's sign: passive overpressure at full shoulder flexion with the scapula fixed
     • Hawkins test: passive internal rotation at 90 degree of shoulder flexion in the scapular plane and in progressive degree of horizontal adduction

  2. 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:

• Patients who received any drug by subacromial injection for treatment within 3 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 who have a isolated acromioclavicular joint pathology
• Patients who have a full-thickness rotator cuff tear (evidenced by MR or ultrasonography)
• Patients with symptomatic cervical spine disorders
• Patients who have a History of allergic adverse reactions to corticosteroid
• Patients are unable to give informed consent to participate in the study
• Patients are unable to come into the clinic for regular follow-up
• Patients with adhesive capsulitis- acromioclavicular arthropathy- polyarthritis- infectious arthritis- rheumatoid arthritis or diagnosed fibromyalgia
• Patients with concurrent bilateral shoulder pain
• Patients with neurological deficit
• Patients who have severely abnormal radiological findings including malignancy, severe osteoarthritis of the glenohumeral joint, severe skeletal abnormalities decreasing the subacromial space and etc.
• 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
• Patients with Diabetes mellitus
• Patients taking anticoagulants
• Pregnant women or lactating mothers
• Patients who are difficulty participating in data collection due to communication problem and 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

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Constant-Murley score	The Constant-Murley score (CMS) is a 100-points scale composed of parameters defining the level of pain and the ability of performing daily activities.	Postinjection 1month

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: December 18, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: BRM-13-01