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

February 13, 2012 updated by: University of Aarhus

Treatment of Lateral Epicondylitis. Platelet Rich Plasma vs. Steroid vs. Saline Solution

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Silkeborg, Denmark, 8600
        • Silkeborg Regional Hospital Department of Reumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Platelet Rich Plasma
Biological: Platelet Rich Plasma
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.
Other Names:
  • PRP
  • Plasma, Platelet Rich
  • Blood Platelets
SHAM_COMPARATOR: Isotonoic Saline Solution
Procedure: Isotonic Saline Solutions
3ml of Isotonic Saline Solution is injected into the tendon through 7 perforations of the tendon, guided by ultrasound.
Other Names:
  • Physiological Saline Solution
ACTIVE_COMPARATOR: Steroid (Triamcinolonacetonid)
Drug: Triamcinolonacetonid
Triamcinolonacetonid 40mg/ml. 40mg of Triamcinolonacetonid is mixed with 2ml of Lidocaine 10mg/ml. It is injected deep into the tendon, guided by ultrasound.
Other Names:
  • Kenalog

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

April 21, 2010

First Submitted That Met QC Criteria

April 22, 2010

First Posted (ESTIMATE)

April 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2012

Last Update Submitted That Met QC Criteria

February 13, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP RCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lateral Epicondylitis

Clinical Trials on Platelet Rich Plasma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe