Treatment of Lateral Epicondylitis: Platelet Rich Plasma Versus Steroid Versus Saline Solution

University of Aarhus60 enrolled

Overview

We wish to address the efficacy and safety of Platelet Rich Plasma (blood platelets), a new treatment for lateral epicondylitis (tennis elbow) and compare this new treatment to either injection with steroid or saline solution. All injections are guided by ultrasonography.

Plate Rich Plasma (PRP) is a new treatment for tendinopathy. A high concentration of blood platelets is made from the patients own blod, and then injected into the tendon. The idea is that the complex mixture of growth factors within the platelets can stimulate the healing process of the tendon. We want to address the efficacy and safety of this new treatment and compare it to either the best documented treatment, Steroid injection, or to a saline solution. We want to make a randomized controlled trial with 60 participants, 20 in each of the 3 groups, and a 12 months follow up. All injections are guided by ultrasonography.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lateral Epicondylitis

Interventions

Platelet Rich PlasmaBIOLOGICAL

27ml of autologous whole blood added to 3ml of ACD-A (Citrate Anticoagulant). After separation of the platelets, a high concentration of platelets (3-4ml Platelet Rich Plasma) is injected into the tendon through 7 perforations of the tendon, guided by ultrasound.

Isotonic Saline SolutionsPROCEDURE

3ml of Isotonic Saline Solution is injected into the tendon through 7 perforations of the tendon, guided by ultrasound.

TriamcinolonacetonidDRUG

Triamcinolonacetonid 40mg/ml. 40mg of Triamcinolonacetonid is mixed with 2ml of Lidocaine 10mg/ml. It is injected deep into the tendon, guided by ultrasound.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Duration of tennis elbow \> 6 months * Doppler activity on ultrasonography * Lateral elbow pain that is maximal over the lateral epicondyle, and increases with pressure on the lateral epicondyle, and resisted dorsiflexion and/or middle finger. Exclusion Criteria: * Inflammatory disease. * Fibromyalgia. * Pain in hand or shoulder/neck in the same arm as being treated. * Anticoagulation treatment. * Wounds around the elbow. * Treatment with steroids within the last 3 months.

Locations (1)

Silkeborg Regional Hospital Department of Reumatology

Silkeborg, Denmark

Outcomes

Primary Outcomes

Changes in pain as a continuous outcome measure. Using The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionaire.

We use the PRTEE questionaire, which is validated for tennis elbow.

Time frame: first day, 1 months, 3 months, 6 months, 12 months.

Secondary Outcomes

Functional Disability

We use the PRTEE questionaire, validated for tennis elbow.

Time frame: First day, 1 month, 3 months, 6 months, 12 months

Ultrasonographic changes

We meassure ultrasonographic changes in: tendon thickness and doppler activity.

Time frame: first day, 1 months, 3 months, 6 months, 12 months

Adverse events

The number of adverse events leading to withdrawal

Time frame: through out the entire 12 months

Pain induced by the treatment

A numeric scale 0-10 adressing if the treatment caused any aditional pain, and the duration: \<1 week, 1-2 week, 3-4 weeks, \> 4 weeks.

Time frame: 1 months after treatment

Data from ClinicalTrials.gov

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