Arthroscopic Debridement Versus Autologous Cytokine Rich Serum for the Treatment of Lateral Epicondylitis

Not Applicable

• Conditions: Epicondylitis, Lateral
• Interventions: Procedure: Arthroscopic Resection; Biological: Autologous Cytokine Rich Serum

• Registration Number: NCT04194710
• Lead Sponsor: Corporacion Parc Tauli

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.

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-11
• Status Verified: 2020-12
• Study Start: 2020-12-22
• Last Update Submitted: 2020-12-23
• Last Update Posted: 2020-12-24
• Primary Completion: 2023-07-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cytokine rich serum injection	Arthroscopic Resection	43 patients will be assigned to this arm. After randomization, patients will be informed and the first injection of serum rich cytokines will be scheduled. After 15 days, they will be injected again with serum rich cytokines.
Arthroscopic Resection	Autologous Cytokine Rich Serum	43 patients will be assigned to this arm. This is the standard technique to treat lateral epicondylitis. After randomization, patients will be informed and the surgery will be scheduled.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
occurrence of pain with resisted wrist extension	15 days, 1-3-6-12-24 months after intervention	assessed during medical examination

Trial Locations

Locations (2)

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Corporació Sanitària Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain