Epicondylitis, Lateral
Conditions
Brief summary
This study aims to compare arthroscopic resection (surgical intervention) versus infiltration of cytokine rich serum (CRS) (proteins derived from the patient's own blood) for the treatment of lateral epicondylitis (LE).
Detailed description
Lateral epicondylitis (LE) is a common debilitating condition that affects the extensor muscles of the forearm at its junction with the lateral humeral epicondyle. This pathology is commonly treated by a surgical intervention. However, advances in research have allowed the discovery of new and less invasive techniques for its treatment, for example the infiltration of cytokine rich serum. The aim of the study is to compare the common treatment of this pathology, arthroscopic resection (surgical intervention) with a new technique, infiltration of cytokine rich serum (CRS) (proteins derived from the patient's own blood) with respect to medium and long-term pain reduction. The study will include a total of 86 patients. Patients will be included by randomization into two groups: * GROUP 1: 43 patients will be treated with 2 infiltrations of cytokine rich serum. * GROUP 2: 43 patients will be treated by a regular surgical treatment consisting of arthroscopic resection. The main objective of this study is to evaluate the efficacy of CRS as compared to arthroscopic resection in reducing pain in the medium term (6 months) in patients with chronic lateral epicondylitis.
Interventions
BIOLOGICALAutologous Cytokine Rich Serum
Proteins, called cytokines, released from blood platelets and leukocytes, play an important role in the repair and regeneration of the injured tissue that causes lateral epicondylitis. Autologous Cytokine Rich Serum is prepared by the medical devise Q-Cytokine (CE MED31489) from patient's blood. The company Tecnologia Regenerativa Qrem S.L., with licence number 7096-PS from Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), is the manufacturer of this product. Q-Cytokine is a lab-in-a-box devise, and consist of an automatic centrifuge and a sterile disposable kit. After 9 steps of centrifugation, that take place in 36 minutes, Cytokine Rich Serum is obtained. This Cytokine Rich Serum is then injected to the epicondyle. Patients randomized to this treatment will receive 1 injections of Autologous Cytokine Rich Serum right after randomization and another one after 15 days. This process will take place at outpatient clinics.
PROCEDUREArthroscopic Resection
Surgical treatment of resection by arthroscopy is the standard treatment for chronic epicondylitis. The surgery is performed in the operating room under local anesthesia and lasts approximately 30 minutes. During the surgery, the doctor accesses the tendon by arthroscopy to perform an exeresis of the degenerated tendon. After the operation, the patient is directed to the recovery room where the responsible doctor will perform a physical examination and examination before leaving the center. This process will take place at the major ambulatory surgery center of the investigator's hospital.
Sponsors
Tecnologia Regenerativa Qrem S.L.
Corporacion Parc Tauli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years of age * Patients with persistent pain (EVA \> 5) at lateral epicondyle level of at least 3 months duration. * Patients with a diagnosis of chronic lateral epicondylitis confirmed with a complementary diagnostic test such as Echo or MRI. * Availability to follow the study protocol for up to 24 months. * Patients with the ability to understand study information and give informed consent. * Patients who sign informed consent. * Normal hematologic parameters.
Exclusion criteria
* Local infection present. * Patients who have been treated with corticosteroid infiltrations in the same area in the past 4 months. * Patients who have received treatment with growth factors, PRP, cytokines, or new drug treatments in the same area in the last 12 months. * Pregnancy or breast-feeding. * Neoplastic disease. * Patients being treated with immunosuppressants (medical evaluation). * Patients undergoing arthroscopic surgery of the same elbow. * Active liver disease. * Immunosuppressive or immunodeficiency states. * Coagulation deficit or abnormalities. * Thrombocytopenia. * Treatment with anticoagulants. * Difficulty understanding and following study procedures. * Participation in a clinical trial with medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | 6 months | reduction of pain to 6 months measured with the Visual Analogue Scale (EVA) scale. The specification of the efficacy parameter is an absolute improvement of the 2-point scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Related Tennis Elbow Evaluation (PRTEE) | 15 days, 1-3-6-12-24 months after intervention | The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis. It is a is a 15-item questionnaire allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists in two subscales: 1. PAIN subscale (0 = no pain, 10 = worst imaginable) - 5 items 2. FUNCTION subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items Usual activities - 4 items |
| Grip force | 15 days, 1-3-6-12-24 months after intervention | measured with a palm grip dynamometer, in kilos |
| Pain assessment with Visual Analogue Scale (EVA) scale | 15 days, 1-3-12-24 months after intervention | Visual Analogue Scale (EVA) from 0 to 10 points, being 0 no pain, and 10 maximum pain |
| Number of participants with complications related to the treatment | 15 days, 1-3-6-12-24 months after intervention | assessed during medical examination |
| Revision of anti-inflammatory medication and its dose | 15 days, 1-3-6-12-24 months after intervention | assessed during medical examination |
| occurrence of pain with resisted wrist extension | 15 days, 1-3-6-12-24 months after intervention | assessed during medical examination |
Countries
Spain
Contacts
Primary ContactLaia Martínez Carreres, PhD
Backup ContactMònica Salomó, MD
Outcome results
None listed