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Completed

NCT Number: NCT01851044

The Effect of Platelet Rich Plasma on Lateral Epicondylitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hatanpää City Hospital

Tampere, 33101, Finland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet rich plasma

Procedure

Whole Blood Injection

Procedure

Saline injection

Procedure

Primary outcomes

  1. Pain (Visual Analog Scale)

    Time frame: 52 weeks

Secondary outcomes

  1. Disabilities of the Arm, Shoulder and Hand -score

    Time frame: 52 weeks

Other outcomes

  1. Grip strength (Jamar)

    Time frame: 52 weeks

  2. Need for non-steroidal anti-inflammatory drugs (NSAID)

    Time frame: 52 weeks

  3. The duration of the potential sick leave due to lateral epicondylitis

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

  • Hatanpää City Hospital, Tampere, Finland

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
May 10, 2013
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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