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Completed

NCT Number: NCT02019537

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

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

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Key information

Conditions

Shoulder Impingement Syndrome Joint Diseases Musculoskeletal Diseases Shoulder Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 156-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Postinjection 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.

  2. Constant-Murley score

    Time frame: Postinjection 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 24, 2013
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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