search
Back to results

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

Primary Purpose

Shoulder Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Steroid injection into the subacromial space
Allogeneic PRP injection into the subacromial space
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Steroid group

PRP group

Arm Description

Triamcinolone injection group

Allogeneic PRP injection group

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2013
Last Updated
September 16, 2020
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02019537
Brief Title
Subacromial Injection of Allogeneic Platelet Rich Plasma (PRP) for Shoulder Impingement Syndrome
Official Title
Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Steroid group
Arm Type
Active Comparator
Arm Description
Triamcinolone injection group
Arm Title
PRP group
Arm Type
Experimental
Arm Description
Allogeneic PRP injection group
Intervention Type
Procedure
Intervention Name(s)
Steroid injection into the subacromial space
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Allogeneic PRP injection into the subacromial space
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety determined with symptoms & signs of infection and immune response and adverse events evaluated with NCI-CTCAE v3.0
Description
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.
Time Frame
Postinjection 1month
Title
Constant-Murley score
Description
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.
Time Frame
Postinjection 1month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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 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
Facility Information:
Facility Name
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs