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Clinical Trials/NCT01851044
NCT01851044CompletedNot Applicable

The Treatment of Lateral Epicondylitis: the Effect of Platelet Rich Plasma on Healing -- A Randomized Controlled Double-Blinded Trial

Tampere University2 sites in 1 country120 target enrollmentStarted: February 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
2
Primary Endpoint
Pain (Visual Analog Scale)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Vehicle (Saline)

Placebo Comparator

2 ml of saline is injected to the proximal insertion of extensor carpi radialis brevis (ECRB) muscle.

Intervention: Platelet Rich Plasma (Procedure)

Whole Blood

Active Comparator

2 ml of patient own venous blood is injected to the proximal insertion of ECRB.

Intervention: Whole Blood Injection (Procedure)

Platelet Rich Plasma

Experimental

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.

Intervention: Saline Injection (Procedure)

Outcomes

Primary Outcomes

Pain (Visual Analog Scale)

Time Frame: 52 weeks

Secondary Outcomes

  • Disabilities of the Arm, Shoulder and Hand -score(52 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Olli Leppänen

Researcher

Tampere University

Study Sites (2)

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