Randomized Clinical Trial Comparing Arthroscopic Debridement Versus Autologous Cytokine Rich Serum for the Treatment of Lateral Epicondylitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Pain assessment
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain assessment
时间窗: 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.
次要结局
- Number of participants with complications related to the treatment(15 days, 1-3-6-12-24 months after intervention)
- Revision of anti-inflammatory medication and its dose(15 days, 1-3-6-12-24 months after intervention)
- Patient-Related Tennis Elbow Evaluation (PRTEE)(15 days, 1-3-6-12-24 months after intervention)
- Grip force(15 days, 1-3-6-12-24 months after intervention)
- Pain assessment with Visual Analogue Scale (EVA) scale(15 days, 1-3-12-24 months after intervention)
- occurrence of pain with resisted wrist extension(15 days, 1-3-6-12-24 months after intervention)
研究者
Ferran Fillat Gomà
Co-Investigator
Corporacion Parc Tauli