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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: 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 Summary:

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 Sho
Sponsor: American University of Beirut Medical Center

Current Primary Outcome: Constant-Murley Total Score [ Time Frame: 6 months post-injection ]

The sum of scores from different domains of Constant-Murley Questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • Constant-Murley Pain Score [ Time Frame: 6 months post-injection ]
    Pain score derived from Pain domain of Constant-Murley Questionnaire
  • Constant-Murley Pina 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


Information By: American University of Beirut Medical Center

Dates:
Date Received: October 15, 2015
Date Started: September 2015
Date Completion: January 2017
Last Updated: January 23, 2017
Last Verified: January 2017