Clinical trial NCT02019537: 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
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

  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

Primary outcomes:
measure: Safety determined with symptoms & signs of infection and immune response and adverse events evaluated with NCI-CTCAE v3.0
timeFrame: Postinjection 1month
measure: Constant-Murley score
timeFrame: Postinjection 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Study officials:
References: