The Effect of Platelet Rich Plasma on Lateral Epicondylitis

Tampere University

Status: Completed

Conditions: Elbow Pain; Lateral Epicondylitis

Treatments: Procedure: Saline Injection; Procedure: Platelet Rich Plasma; Procedure: Whole Blood Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01851044

R11031

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

Vehicle (Saline)

Placebo Comparator group

Description:

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

Treatment:

Procedure: Platelet Rich Plasma

Whole Blood

Active Comparator group

Description:

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

Treatment:

Procedure: Whole Blood Injection

Platelet Rich Plasma

Experimental group

Description:

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.

Treatment:

Procedure: Saline Injection