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

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Shoulder Impingement Syndrome

Treatments

Procedure: Allogeneic PRP injection into the subacromial space
Procedure: Steroid injection into the subacromial space

Study type

Interventional

Funder types

Other

Identifiers

NCT02019537
BRM-13-01

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Steroid group
Active Comparator group
Description:
Triamcinolone injection group
Treatment:
Procedure: Steroid injection into the subacromial space
PRP group
Experimental group
Description:
Allogeneic PRP injection group
Treatment:
Procedure: Allogeneic PRP injection into the subacromial space

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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