The Effect of Platelet Rich Plasma on Lateral Epicondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01851044
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : October 11, 2018
Hatanpää City Hospital, Tampere, Finland
Information provided by (Responsible Party):
Olli Leppänen, University of Tampere

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.

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Elbow Pain Procedure: Platelet Rich Plasma Procedure: Whole Blood Injection Procedure: Saline Injection Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Treatment of Lateral Epicondylitis: the Effect of Platelet Rich Plasma on Healing -- A Randomized Controlled Double-Blinded Trial
Study Start Date : February 2011
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Vehicle (Saline)
2 ml of saline is injected to the proximal insertion of extensor carpi radialis brevis (ECRB) muscle.
Procedure: Platelet Rich Plasma
Active Comparator: Whole Blood
2 ml of patient own venous blood is injected to the proximal insertion of ECRB.
Procedure: Whole Blood Injection
Experimental: Platelet Rich Plasma
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.
Procedure: Saline Injection

Primary Outcome Measures :
  1. Pain (Visual Analog Scale) [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Disabilities of the Arm, Shoulder and Hand -score [ Time Frame: 52 weeks ]

Other Outcome Measures:
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01851044

Hatanpää City Hospital
Tampere, Finland, 33101
Sponsors and Collaborators
University of Tampere
Hatanpää City Hospital, Tampere, Finland

Responsible Party: Olli Leppänen, Researcher, University of Tampere Identifier: NCT01851044     History of Changes
Other Study ID Numbers: R11031
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by Olli Leppänen, University of Tampere:
Platelet Rich Plasma
Whole Blood Injection
Lateral Epicondylitis
Tennis Elbow

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries