Subacromial Injection of Allogeneic Platelet Rich Plasma... | NCT02019537

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Steroid group	Active Comparator	Triamcinolone injection group	Procedure: Steroid injection into the subacromial space
PRP group	Experimental	Allogeneic PRP injection group	Procedure: Allogeneic PRP injection into the subacromial space

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Postinjection 1month
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.	Postinjection 1month

Eligibility Module

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

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D000070599	Shoulder Injuries
D014947	Wounds and Injuries