Platelet-rich Plasma (PRP) Injection for Treating Shoulder Subacromial Impingement Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine whether injection of platelet-rich plasma derived from patient's blood is effective in treatment of shoulder subacromial impingement syndrome as compared to the current protocol of methylprednisolone injection.

Detailed Description
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Patients presenting with shoulder pain to the study location will be screened by the principal investigator. Once diagnosed clinically with shoulder subacromial impingement syndrome, they will be invited to join the study. They will be invited to separate academic office to be explained about the study, its voluntary and confidential basis as per our Institutional Review Board (IRB) approved protocols. After signing informed consent form and recruitment, they will be assigned randomly to one of the study arms through software-generated sequential allocation packaged in an opaque envelope. All involved except the principal investigator and patient are blinded. There are two groups/arms in the study. The experimental arm will include subacromial injection of study subjects with autologous platelet-rich plasma; wheres subjects in the other study arm will be injected with methylprednisolone. The outcome will be assessed through three scores. The study subjects will be asked to complete Oxford Shoulder Score questionnaire and health-related quality of life SF-36 questionnaire and Constant-Murley score will be measured through physician-based assessment done by the residents involved in the study. This will be done during the baseline visit before injection and repeated at 2, 6, 12 weeks and 6 months follow-up visits. Also any adverse effects of both treatment arms will be monitored and reported as appropriate. The investigators hypothesize that injecting platelet-rich plasma into the subacromial space of patients with subacromial impingement will result in decreased pain and increased function at 6 months follow-up (assessed by Constant-Murley Score, Oxford Shoulder Score, and Short Form-36 (SF-36) questionnaire) as compared to patients injected with methylprednisolone.

Official Title
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Comparing Subacromial Injection of Platelet-rich Plasma Versus Methylprednisolone in the Treatment of Shoulder Subacromial Impingement Syndrome

Conditions
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Shoulder Impingement Syndrome

Intervention / Treatment
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* Drug: platelet-rich plasma group
* Drug: Methylprednisolone group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any adult male or female between 18 and 65 years of age, inclusive, with clinical diagnosis of shoulder subacromial impingement Exclusion Criteria: Age below 18 or above 65 years History of prior shoulder injections or surgery History of fracture of the acromion, clavicle, scapula, or proximal humerus Known allergy to corticosteroids Known allergy to lidocaine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platelet-rich plasma group<br>Autologous platelet-rich plasma subacromial injection | Drug: platelet-rich plasma group<br>* Once randomized to platelet-rich plasma arm, the study subject will have 30cc of blood drawn and centrifuged using the Recover(TM) Platelet Separation Kit (Biomet Biologics, Warsaw, Indiana, USA). The extracted platelet-rich plasma part will be re-injected into the subacromial space of the subject's affected shoulder.<br>* Other names: PRP;|
| Active Comparator: Methylprednisolone group<br>Methylprednisolone subacromial injection | Drug: Methylprednisolone group<br>* Once randomized to Methylprednisolone arm, the study subject will have an injection with 2ml of Methylprednisolone (40mg/ml methylprednisolone acetate injectable suspension) (Pharmacia Upjohn, Kalamazoo, Michigan, USA) with 2ml of lidocaine hydrochloride 2% (Hameln Pharmaceuticals Ltd, Gloucester, UK) into the subacromial space of their affected shoulder.<br>* Other names: methylprednisolone acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-Murley Total Score | The sum of scores from different domains of Constant-Murley Questionnaire | 6 months post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-Murley Pain Score | Pain score derived from Pain domain of Constant-Murley Questionnaire | 6 months post-injection | 
| Constant-Murley Function score | Function score derived from function domain of Constant-Murley Questionnaire | 6 months post-injection | 
| Constant-Murley ROM score | Range of motion assessment score derived from range of motion domain of Constant-Murley Questionnaire | 6 months post-injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subacromial injection, methylprednisolone, treatment, Platelet-rich plasma