Radial Shock Waves Versus Focal Shock Waves in the Treatment of Lateral Epicondylalgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain with Visual Analogue Scale (VAS)
研究概览
简要总结
Lateral epicondylalgia (LET) is characterized by pain, decreased muscle strength of the wrist extensor muscles, and disability. Among the treatments proposed in the literature, both focal shockwave therapy and radial shockwave therapy have been considered effective in the management of this musculoskeletal disorder. The objective of this study is to compare the safety and effectiveness of these two shockwave applications on the signs and symptoms of subjects with lateral epicondylalgia. In this clinical trial, subjects will be evaluated for elbow pain using a Visual Analog Scale (VAS), grip strength using a handheld dynamometer, and degree of disability using the Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE). A six-month follow-up will be performed.
Patients will be randomly divided into three groups. The first group will receive radial shock waves (rESWT), the second group will receive focal shock waves (fESWT), and the third group, which will act as a control, will receive a placebo treatment with very low energy parameters according to the literature.
Subjects will receive three sessions, one session per week.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain in the lateral epicondyle >3 months
- •Pain when performing resisted grip
- •Positive Cozen test
- •Positive Maudsley test
排除标准
- •Pregnancy
- •Systemic diseases (Fibromyalgia, Diabetes, Arthritis)
- •Local infection or Cancer
- •Recent treatments (Physiotherapy, Corticosteroids)-
研究组 & 干预措施
Radial Shock Wave Treatment
Patients assigned to this group will receive three sessions. During each session, 2000 pulses will be administered using a radial shock wave generator, with a pressure of 2.5 bars and a frequency of 8 Hz.
干预措施: Radial shock waves treatment (Other)
Focal Shock Wave Treatment
Patients assigned to this group will receive three sessions. During each session, 2000 pulses will be delivered by a focal shock wave generator, with an energy flux density of 0.2 mJ/mm² and a frequency of 4 Hz.
干预措施: Focal Shock Waves treatment (Other)
Placebo Shock Waves
Subjects in this group will receive a placebo treatment with very low energy settings, designed to simulate therapy without offering real therapeutic effects. This group will receive 20 pulses per session, with an energy flux density of 0.08 mJ/mm².
干预措施: shock waves placebo treatment (Other)
结局指标
主要结局
Pain with Visual Analogue Scale (VAS)
时间窗: Change from Baseline pain at 6 month
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured where "0" on the far left is no pain and "10" on the far right is the worst pain possible.
次要结局
- Grip strength(Change from Baseline pain at 6 month)
- Patient Rated Tennis Elbow Evaluation (PRTEE)(Change from Baseline pain at 6 month)
- The Global Rating of Change (GROC)(Change from Baseline pain at 6 month)
研究者
Prof. Dr. Daniel Pecos Martín
Professor
University of Alcala