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

Not Applicable
Completed
Conditions
Shoulder Impingement Syndrome
Interventions
Procedure: Allogeneic PRP injection into the subacromial space
Procedure: Steroid injection into the subacromial space
Registration Number
NCT02019537
Lead Sponsor
Seoul National University Hospital
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PRP groupAllogeneic PRP injection into the subacromial spaceAllogeneic PRP injection group
Steroid groupSteroid injection into the subacromial spaceTriamcinolone injection group
Primary Outcome Measures
NameTimeMethod
Constant-Murley scorePostinjection 1month

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.

Safety determined with symptoms & signs of infection and immune response and adverse events evaluated with NCI-CTCAE v3.0Postinjection 1month

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

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

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Seoul, Korea, Republic of

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