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

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109446
• Other study ID #: PRP RCT
• Status: Completed
• Phase: N/A
• First received: April 21, 2010
• Last updated: February 13, 2012
• Start date: January 2009
• Est. completion date: October 2011

Study information

• Verified date: February 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

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.

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

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.

Locations

Country	Name	City	State
Denmark	Silkeborg Regional Hospital Department of Reumatology	Silkeborg

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	first day, 1 months, 3 months, 6 months, 12 months.	No
Secondary	Functional Disability	We use the PRTEE questionaire, validated for tennis elbow.	First day, 1 month, 3 months, 6 months, 12 months	No
Secondary	Ultrasonographic changes	We meassure ultrasonographic changes in: tendon thickness and doppler activity.	first day, 1 months, 3 months, 6 months, 12 months	No
Secondary	Adverse events	The number of adverse events leading to withdrawal	through out the entire 12 months	Yes
Secondary	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.	1 months after treatment	No