The Effect of Platelet Rich Plasma on Lateral Epicondylitis

Not Applicable

Completed

• Conditions: Elbow Pain; Lateral Epicondylitis
• Interventions: Procedure: Platelet Rich Plasma; Procedure: Whole Blood Injection; Procedure: Saline Injection

• Registration Number: NCT01851044
• Lead Sponsor: Tampere University

Brief Summary

The purpose of this study is to compare the effects of platelet rich plasma, whole blood and saline vehicle on the natural course of lateral epicondylitis.

Detailed Description

Lateral epicondylitis, also known as "tennis elbow", is the most common work-related disease of the upper extremity. Usually it has favorable natural healing-tendency, but sometimes it is responsible for long-lasting disability. The pathogenesis of this disease has remained unclear, however it has been speculated that the role of inflammation is smaller than previously believed. Instead, anatomical and vascular factors may play a much greater role. The evidence for the operative treatment is lacking, and the conservative treatment is therefore preferred. The conservative treatment used to rely largely on corticosteroid injections to the extensor muscle insertions. However, it has been shown that corticosteroids, in fact, tend to increase the subjective pain in the long run. Several studies -- most of them unfortunately underpowered -- have been carried out to find an efficient conservative treatment to this disease, but none of them has turned out to be significantly better than others. During the last couple of years, platelet rich plasma (PRP) has been used as a treatment in several musculoskeletal diseases (e.g. fracture healing, cartilage regeneration, wound healing). PRP is a substance centrifuged from patient own blood. There are a couple of studies regarding the use of PRP in lateral epicondylitis. The results are mostly positive; however it has not been thoroughly shown that it would be more effective than patient's whole blood. The hypothesis of this study is that PRP is more effective in the treatment of lateral epicondylitis than whole blood or saline vehicle injection. The primary outcome measures are pain (VAS) and the Disabilities of the Arm, Shoulder and Hand -score (DASH).

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2013-05-05
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-10
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• The duration of symptoms over 3 months
• Primary conservative treatment (physiotherapy, NSAID, ...) has been tried

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Exclusion Criteria

• Significant systemic diseases
• Any surgical operation of the particular elbow

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle (Saline)	Platelet Rich Plasma	2 ml of saline is injected to the proximal insertion of extensor carpi radialis brevis (ECRB) muscle.
Whole Blood	Whole Blood Injection	2 ml of patient own venous blood is injected to the proximal insertion of ECRB.
Platelet Rich Plasma	Saline Injection	9 ml of patient own venous blood is centrifuged using The Arthrex ACP® Double Syringe System and 2 ml of platelet rich plasma is injected to the proximal insertion of ECRB.

Primary Outcome Measures

Name	Time	Method
Pain (Visual Analog Scale)	52 weeks

Secondary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder and Hand -score	52 weeks

Trial Locations

Locations (1)

Hatanpää City Hospital; 🇫🇮 Tampere, Finland