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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
86
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.
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.
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
RECRUITINGHospital Clínic i Provincial de Barcelona
Barcelona, Spain
NOT_YET_RECRUITINGPain assessment
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.
Time frame: 6 months
Pain assessment with Visual Analogue Scale (EVA) scale
Visual Analogue Scale (EVA) from 0 to 10 points, being 0 no pain, and 10 maximum pain
Time frame: 15 days, 1-3-12-24 months after intervention
Patient-Related Tennis Elbow Evaluation (PRTEE)
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
Time frame: 15 days, 1-3-6-12-24 months after intervention
Grip force
measured with a palm grip dynamometer, in kilos
Time frame: 15 days, 1-3-6-12-24 months after intervention
occurrence of pain with resisted wrist extension
assessed during medical examination
Time frame: 15 days, 1-3-6-12-24 months after intervention
Number of participants with complications related to the treatment
assessed during medical examination
Time frame: 15 days, 1-3-6-12-24 months after intervention
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Revision of anti-inflammatory medication and its dose
assessed during medical examination
Time frame: 15 days, 1-3-6-12-24 months after intervention