NCT02669303

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

October 15, 2015

Last Update Submit

June 27, 2017

Conditions

Shoulder Impingement Syndrome

Keywords

Subacromial injectionmethylprednisolonetreatmentPlatelet-rich plasma

Outcome Measures

Primary Outcomes (1)

  • Constant-Murley Total Score

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

    6 months post-injection

Secondary Outcomes (3)

  • Constant-Murley Pain Score

    6 months post-injection

  • Constant-Murley Function score

    6 months post-injection

  • Constant-Murley ROM score

    6 months post-injection

Study Arms (2)

platelet-rich plasma group

EXPERIMENTAL

Autologous platelet-rich plasma subacromial injection

Drug: platelet-rich plasma group

Methylprednisolone group

ACTIVE COMPARATOR

Methylprednisolone subacromial injection

Drug: Methylprednisolone group

Interventions

platelet-rich plasma groupDRUG

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.

Also known as: autologous platelet-rich plasma, PRP
platelet-rich plasma group
Methylprednisolone groupDRUG

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.

Also known as: methylprednisolone acetate
Methylprednisolone group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any adult male or female between 18 and 65 years of age, inclusive, with clinical diagnosis of shoulder subacromial impingement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, 11-236, Lebanon

Location

Related Publications (3)

  • 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.

    PMID: 21422467BACKGROUND

  • 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.

    PMID: 15779147BACKGROUND

  • 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.

    PMID: 20044683BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Muhyeddine Al-Taki, MD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Surgery

Study Record Dates

First Submitted

October 15, 2015

First Posted

February 1, 2016

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

June 28, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)