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Completed

NCT Number: NCT01109446

Treatment of Lateral Epicondylitis: Platelet Rich Plasma Versus Steroid Versus 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.

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Key information

Conditions

Lateral Epicondylitis Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Silkeborg Regional Hospital Department of Reumatology

Silkeborg, 8600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Platelet rich plasma

Biological

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

Isotonic Saline Solutions

Procedure

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

Other names: Physiological Saline Solution

Triamcinolonacetonid

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 23, 2010
Registry last updated
Feb 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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