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

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ClinicalTrials.gov Identifier: NCT01109446
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : February 14, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Lateral Epicondylitis Biological: Platelet Rich Plasma Procedure: Isotonic Saline Solutions Drug: Triamcinolonacetonid

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Lateral Epicondylitis. Platelet Rich Plasma vs. Steroid vs. Saline Solution
Study Start Date : January 2009
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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:
  • 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

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Functional Disability [ Time Frame: First day, 1 month, 3 months, 6 months, 12 months ]
    We use the PRTEE questionaire, validated for tennis elbow.

  2. Ultrasonographic changes [ Time Frame: first day, 1 months, 3 months, 6 months, 12 months ]
    We meassure ultrasonographic changes in: tendon thickness and doppler activity.

  3. Adverse events [ Time Frame: through out the entire 12 months ]
    The number of adverse events leading to withdrawal

  4. 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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109446

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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01109446     History of Changes
Other Study ID Numbers: PRP RCT
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Pharmaceutical Solutions