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

Primary Purpose

Lateral Epicondylitis

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Platelet Rich Plasma

Isotonic Saline Solutions

Triamcinolonacetonid

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Lateral Epicondylitis, Tennis Elbow, Epicondylitis Lateralis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Silkeborg Regional Hospital Department of Reumatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

Platelet Rich Plasma

Isotonoic Saline Solution

Steroid (Triamcinolonacetonid)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Functional Disability

We use the PRTEE questionaire, validated for tennis elbow.

Ultrasonographic changes

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

Adverse events

The number of adverse events leading to withdrawal

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.

Full Information

NCT ID

NCT01109446

First Posted

April 21, 2010

Last Updated

February 13, 2012

Sponsor

University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT01109446

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lateral Epicondylitis

Keywords

Lateral Epicondylitis, Tennis Elbow, Epicondylitis Lateralis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Platelet Rich Plasma

Arm Type

Experimental

Arm Title

Isotonoic Saline Solution

Arm Type

Sham Comparator

Arm Title

Steroid (Triamcinolonacetonid)

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Platelet Rich Plasma

Other Intervention Name(s)

Plasma, Platelet Rich, PRP, Blood Platelets

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Isotonic Saline Solutions

Other Intervention Name(s)

Physiological Saline Solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Triamcinolonacetonid

Other Intervention Name(s)

Kenalog

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

first day, 1 months, 3 months, 6 months, 12 months.

Secondary Outcome Measure Information:

Title

Functional Disability

Description

We use the PRTEE questionaire, validated for tennis elbow.

Time Frame

First day, 1 month, 3 months, 6 months, 12 months

Title

Ultrasonographic changes

Description

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

Time Frame

first day, 1 months, 3 months, 6 months, 12 months

Title

Adverse events

Description

The number of adverse events leading to withdrawal

Time Frame

through out the entire 12 months

Title

Pain induced by the treatment

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Silkeborg Regional Hospital Department of Reumatology

City

Silkeborg

ZIP/Postal Code

8600

Country

Denmark

12. IPD Sharing Statement

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

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