The Effect of Platelet Rich Plasma on Lateral Epicondylitis

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851044
• Other study ID #: R11031
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: December 2017

Study information

• Verified date: October 2018
• Source: University of Tampere
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elbow Pain
• Lateral Epicondylitis
• Tennis Elbow

Intervention

Procedure:
• Platelet Rich Plasma

• Whole Blood Injection

• Saline Injection

Locations

Country	Name	City	State
Finland	Hatanpää City Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
University of Tampere	Hatanpää City Hospital, Tampere, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Grip strength (Jamar)		52 weeks
Other	Need for non-steroidal anti-inflammatory drugs (NSAID)		52 weeks
Other	The duration of the potential sick leave due to lateral epicondylitis		52 weeks
Primary	Pain (Visual Analog Scale)		52 weeks
Secondary	Disabilities of the Arm, Shoulder and Hand -score		52 weeks