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

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

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.

Study Overview

• Status: Terminated
• Conditions: Shoulder Impingement Syndrome
• Intervention / Treatment: Drug: platelet-rich plasma group; Drug: Methylprednisolone group

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 11-236
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: PRP; autologous platelet-rich plasma
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 Names: methylprednisolone acetate

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Muhyeddine Al-Taki, MD, American University of Beirut Medical Center

Publications and helpful links

General Publications

• Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.
• Anitua E, Andia I, Sanchez M, Azofra J, del Mar Zalduendo M, de la Fuente M, Nurden P, Nurden AT. Autologous preparations rich in growth factors promote proliferation and induce VEGF and HGF production by human tendon cells in culture. J Orthop Res. 2005 Mar;23(2):281-6. doi: 10.1016/j.orthres.2004.08.015.
• Karthikeyan S, Kwong HT, Upadhyay PK, Parsons N, Drew SJ, Griffin D. A double-blind randomised controlled study comparing subacromial injection of tenoxicam or methylprednisolone in patients with subacromial impingement. J Bone Joint Surg Br. 2010 Jan;92(1):77-82. doi: 10.1302/0301-620X.92B1.22137.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: October 15, 2015
• First Submitted That Met QC Criteria: January 27, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: treatment; methylprednisolone; Platelet-rich plasma; Subacromial injection
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: SUR.MA.134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No