Clinical trial NCT02669303: Platelet-rich Plasma (PRP) Injection for Treating Shoulder Subacromial Impingement Syndrome
Official title: Comparing Subacromial Injection of Platelet-rich Plasma Versus Methylprednisolone in the Treatment of Shoulder Subacromial Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Keywords: Subacromial injection
methylprednisolone
treatment
Platelet-rich plasma
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Constant-Murley Total Score
timeFrame: 6 months post-injection
Secondary outcomes:
measure: Constant-Murley Pain Score
timeFrame: 6 months post-injection
measure: Constant-Murley Function score
timeFrame: 6 months post-injection
measure: Constant-Murley ROM score
timeFrame: 6 months post-injection
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Muhyeddine Al-Taki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.