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

NCT02019537 | Completed

• 1 other identifier: BRM-13-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shoulder Impingement Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Steroid group

ACTIVE COMPARATOR

Triamcinolone injection group

Procedure: Steroid injection into the subacromial space

PRP group

EXPERIMENTAL

Allogeneic PRP injection group

Procedure: Allogeneic PRP injection into the subacromial space

Interventions

Steroid injection into the subacromial space 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 : subacromial space * Material : 25-gauze spinal needle * Subacromial injections were performed using ultrasonographic guidance.

Steroid group

Allogeneic PRP injection into the subacromial space PROCEDURE

* 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.

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 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)
• 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
• 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

You may not qualify if:

• 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

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, 156-707, South Korea

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

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: December 18, 2013
• First Posted: December 24, 2013
• Study Start: February 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

KR (1)