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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01109446
First received: April 21, 2010
Last updated: February 13, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Lateral Epicondylitis
 Biological: Platelet Rich Plasma
Procedure: Isotonic Saline Solutions
Drug: Triamcinolonacetonid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Lateral Epicondylitis. Platelet Rich Plasma vs. Steroid vs. Saline Solution

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    We use the PRTEE questionaire, which is validated for tennis elbow.


Secondary Outcome Measures:
  • Functional Disability [ Time Frame: First day, 1 month, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    We use the PRTEE questionaire, validated for tennis elbow.

  • Ultrasonographic changes [ Time Frame: first day, 1 months, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    We meassure ultrasonographic changes in: tendon thickness and doppler activity.

  • Adverse events [ Time Frame: through out the entire 12 months ] [ Designated as safety issue: Yes ]
    The number of adverse events leading to withdrawal

  • Pain induced by the treatment [ Time Frame: 1 months after treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: January 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Plasma, Platelet Rich
  • PRP
  • 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 Name: 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 Name: Kenalog

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109446

Locations
Denmark
Silkeborg Regional Hospital Department of Reumatology
Silkeborg, Denmark, 8600
Sponsors and Collaborators
University of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01109446     History of Changes
Other Study ID Numbers: PRP RCT
Study First Received: April 21, 2010
Last Updated: February 13, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Lateral Epicondylitis
Tennis Elbow
Epicondylitis Lateralis

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013