Platelet-rich Plasma (PRP) Injection for Treating Shoulder Subacromial Impingement Syndrome (ShIP)
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|ClinicalTrials.gov Identifier: NCT02669303|
Recruitment Status : Terminated (low recruitment rate and high rate of loss-to-followup)
First Posted : February 1, 2016
Last Update Posted : June 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Impingement Syndrome||Drug: platelet-rich plasma group Drug: Methylprednisolone group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparing Subacromial Injection of Platelet-rich Plasma Versus Methylprednisolone in the Treatment of Shoulder Subacromial Impingement Syndrome|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 1, 2017|
Experimental: platelet-rich plasma group
Autologous platelet-rich plasma subacromial injection
Drug: platelet-rich plasma group
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.
Active Comparator: Methylprednisolone group
Methylprednisolone subacromial injection
Drug: Methylprednisolone group
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.
Other Name: methylprednisolone acetate
- Constant-Murley Total Score [ Time Frame: 6 months post-injection ]The sum of scores from different domains of Constant-Murley Questionnaire
- Constant-Murley Pain Score [ Time Frame: 6 months post-injection ]Pain score derived from Pain domain of Constant-Murley Questionnaire
- Constant-Murley Function score [ Time Frame: 6 months post-injection ]Function score derived from function domain of Constant-Murley Questionnaire
- Constant-Murley ROM score [ Time Frame: 6 months post-injection ]Range of motion assessment score derived from range of motion domain of Constant-Murley Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669303
|American University of Beirut Medical Center|
|Beirut, Lebanon, 11-236|
|Principal Investigator:||Muhyeddine Al-Taki, MD||American University of Beirut Medical Center|