Lateral Epicondylitis
Conditions
Keywords
Lateral Epicondylitis, Tennis Elbow, Epicondylitis Lateralis
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.
Interventions
BIOLOGICALPlatelet 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.
PROCEDUREIsotonic Saline Solutions
3ml of Isotonic Saline Solution is injected into the tendon through 7 perforations of the tendon, guided by ultrasound.
DRUGTriamcinolonacetonid
Triamcinolonacetonid 40mg/ml. 40mg of Triamcinolonacetonid is mixed with 2ml of Lidocaine 10mg/ml. It is injected deep into the tendon, guided by ultrasound.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pain as a continuous outcome measure. Using The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionaire. | first day, 1 months, 3 months, 6 months, 12 months. | We use the PRTEE questionaire, which is validated for tennis elbow. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Disability | First day, 1 month, 3 months, 6 months, 12 months | We use the PRTEE questionaire, validated for tennis elbow. |
| Ultrasonographic changes | first day, 1 months, 3 months, 6 months, 12 months | We meassure ultrasonographic changes in: tendon thickness and doppler activity. |
| Adverse events | through out the entire 12 months | The number of adverse events leading to withdrawal |
| Pain induced by the treatment | 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. |
Countries
Denmark
Outcome results
None listed