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.
Procedure: Platelet Rich Plasma
Procedure: Whole Blood Injection
Procedure: Saline Injection
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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|
- Pain (Visual Analog Scale) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Disabilities of the Arm, Shoulder and Hand -score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Grip strength (Jamar) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Need for non-steroidal anti-inflammatory drugs (NSAID) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- The duration of the potential sick leave due to lateral epicondylitis [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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|
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).
|Contact: Olli V Leppänen, M.D., Ph.D.||+firstname.lastname@example.org|
|Contact: Janne Lehtinen, M.D., Ph.D.||email@example.com|
|Hatanpää City Hospital||Recruiting|
|Tampere, Finland, 33101|
|Contact: Janne Lehtinen, M.D., Ph.D. firstname.lastname@example.org|
|Principal Investigator: Olli V. Leppänen, M.D., Ph.D.|
|Principal Investigator: Janne Lehtinen, M.D., Ph.D.|
|Sub-Investigator: Niina Ruopsa, M.D.|
|Sub-Investigator: Tuula Salmi, M.D.|