Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Extent of pain: Numeric Rating Scale (NRS 0-10)
研究概览
简要总结
Lateral epicondylitis is a pathologic condition of the musculotendinous system, characterized by the presence of pain at the lateral epicondyle of the humerus; it is a tendinopathy of the extensor muscles of the forearm, often caused by overuse or repetitive use of the arm, forced extension of the elbow, or direct trauma to the humeral epicondyle. This study evaluated the efficacy of Extracorporeal ShockWave Treatment (ESWT) combined with a supplemental nutraceutical treatment of Hyaluronic Acid, Collagen, Vitamin C, and Manganese, compared with single treatment in patients with lateral epicondylitis in term of improvement in pain, functional capacity, muscle strength, and reduction of inflammation on ultrasound images. A clinical trial was conducted at the U.O.C. of "Recovery and Functional Rehabilitation" of A.O.U.P. "P. Giaccone" of Palermo from Marc 2024 to July 2024. Patients were randomized into 3 groups: in group "A", n° 5 sessions of focal ESWT were given every six days; in group "B", patients took daily for 30 days, supplemental nutraceutical treatment of Hyaluronic Acid, Collagen, Vitamin C, and Manganese; and group "C", patients had combined treatment of ESWT (one session every six days for a total of five sessions) and nutraceutical supplementation (one administration per day for one month). All patients were evaluated at enrollment (T0), after one month, at the end of rehabilitation treatment (T1), and at a follow up 30 days after the end of treatment (T2). Researched will compare patients treated with ESWT or with nutraceutical treatment, and patients who had combined treatment to see if there are real differences in term of pain reduction and improved short- and long-term quality of life.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of lateral epicondylitis;
- •Ultrasound evidence of inflammatory status of the tendon of the wrist common extensor muscle;
- •Numerical Rating Scale (NRS) at T0 ≥ 4;
- •Pharmacological wash out starting seven days before treatment;
- •Written informed consent.
排除标准
- •Pregnancy;
- •Already diagnosed or diagnostically defined neoplasms;
- •Pacemaker wearers;
- •Coagulation disorders and/or anticoagulant therapy;
- •Skin lesions and/or local infections;
- •Tendon injury and/or previous surgery on the wrist extensor tendons;
- •Cervical myelopathy;
- •Epilepsy;
- •Patients with contraindications and/or allergies to the active ingredients of nutracetical supplementation;
- •Obesity with BMI>30 (kg/m2).
结局指标
主要结局
Extent of pain: Numeric Rating Scale (NRS 0-10)
时间窗: At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)
The NRS is a subjective scale that rates the extend of pain with a score between 0 and 10. a score of 10 corresponds to maximum pain.
Intensity of pain and disability: Patient-Rated Tennis Elbow Evaluation Scale (PRTEE)
时间窗: At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2)
This scale consists of 2 parts, namely pain (5 items) and functional activities (10 items). Each item has a score from 0 (no pain or difficulty in performing a task) to 10 (the worst pain or inability to perform a task). The total score is the combined score of the 2 parts
次要结局
- Disability: Disability of the Arm, Shoulder and Hand (DASH) Questionnaire(At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2))
- Handgrip strength(At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2))
- Thickness of the common extensor tendon (CET)(At the time of recruitment (T0) - After 30 day from the start of treatment (T1) - After 30 days from the end of treatment (T2))
研究者
Prof.ssa Giulia Letizia Mauro
Professor
University of Palermo