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

Not Applicable

Completed

• Conditions: Lateral Epicondylitis
• Interventions: Biological: Platelet Rich Plasma; Procedure: Isotonic Saline Solutions; Drug: Triamcinolonacetonid

• Registration Number: NCT01109446
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-13
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma	Platelet Rich Plasma	-
Isotonoic Saline Solution	Isotonic Saline Solutions	-
Steroid (Triamcinolonacetonid)	Triamcinolonacetonid	-

Primary Outcome Measures

Name	Time	Method
Changes in pain as a continuous outcome measure. Using The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionaire.	first day, 1 months, 3 months, 6 months, 12 months.	We use the PRTEE questionaire, which is validated for tennis elbow.

Secondary Outcome Measures

Name	Time	Method
Functional Disability	First day, 1 month, 3 months, 6 months, 12 months	We use the PRTEE questionaire, validated for tennis elbow.
Ultrasonographic changes	first day, 1 months, 3 months, 6 months, 12 months	We meassure ultrasonographic changes in: tendon thickness and doppler activity.
Adverse events	through out the entire 12 months	The number of adverse events leading to withdrawal
Pain induced by the treatment	1 months after 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.

Trial Locations

Locations (1)

Silkeborg Regional Hospital Department of Reumatology; 🇩🇰 Silkeborg, Denmark