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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
Sponsor:
Information provided by (Responsible Party):
Muhyeddine Al-Taki, American University of Beirut Medical Center

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.

Condition or disease Intervention/treatment Phase
Shoulder Impingement Syndrome Drug: platelet-rich plasma group Drug: Methylprednisolone group Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.
Other Names:
  • autologous platelet-rich plasma
  • PRP

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




Primary Outcome Measures :
  1. Constant-Murley Total Score [ Time Frame: 6 months post-injection ]
    The sum of scores from different domains of Constant-Murley Questionnaire


Secondary Outcome Measures :
  1. Constant-Murley Pain Score [ Time Frame: 6 months post-injection ]
    Pain score derived from Pain domain of Constant-Murley Questionnaire

  2. Constant-Murley Function score [ Time Frame: 6 months post-injection ]
    Function score derived from function domain of Constant-Murley Questionnaire

  3. 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 from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Lebanon
American University of Beirut Medical Center
Beirut, Lebanon, 11-236
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Muhyeddine Al-Taki, MD American University of Beirut Medical Center

Publications:
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Responsible Party: Muhyeddine Al-Taki, Assistant Professor of Clinical Surgery, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02669303     History of Changes
Other Study ID Numbers: SUR.MA.134
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Muhyeddine Al-Taki, American University of Beirut Medical Center:
Subacromial injection
methylprednisolone
treatment
Platelet-rich plasma

Additional relevant MeSH terms:
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Syndrome
Rotator Cuff Injuries
Shoulder Impingement Syndrome
Disease
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal