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

NCT ID: NCT02019537

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-07-31

Brief Summary

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

Conditions

Shoulder Impingement Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Steroid group

Triamcinolone injection group

Group Type: ACTIVE_COMPARATOR

Steroid injection into the subacromial space

Intervention Type: 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.

PRP group

Allogeneic PRP injection group

Group Type: EXPERIMENTAL

Allogeneic PRP injection into the subacromial space

Intervention Type: 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.

Interventions

Steroid injection into the subacromial space

• 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.

Intervention Type: PROCEDURE

Allogeneic PRP injection into the subacromial space

• 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyunchul Jo

Associate Professor, SMG-SNU Boramae Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BRM-13-01

Identifier Type: -

Identifier Source: org_study_id