Comparing the Efficacy of Continuous and Pulsed Ultrasound Treatments in Patients With Lateral Epicondylitis : a Double Blind, Randomized and Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 主要终点
- measuring the thickness of common extensor tendon by ultrasound imaging.
研究概览
简要总结
Objectives: The purpose of this study was to investigate the efficacy of continuous and pulsed ultrasound treatments in lateral epicondylitis and to compare the efficacy of these two treatments against each other and placebo.
Patients and Methods: Fifty one patients diagnosed with lateral epicondylitis were included to the study. Patients were randomised to continuous ultrasound, pulsed ultrasound and placebo groups by using closed envelop method. First group received continuous ultrasound treatment. Second group received pulsed ultrasound treatment in proportion as. Third group received of placebo treatment. Resting and moving pain levels of the patients were evaluated by using visual analog scale. Muscle strength was evaluated by using dynamometer. For functional evaluation Duruoz's hand index and Patient-Rated Tennis Elbow Evaluation (PRTEE) scales were used. Evaluations were made at baseline, at the end of the therapy, and one month after the therapy. In addition, at baseline and at the end of the therapy, the thickness of the common extensor tendon was measured by using ultrasonic imaging (USG).
详细描述
The purpose of this study was to investigate the efficacy of continuous and pulsed ultrasound treatments in lateral epicondylitis and to compare the efficacy of these two treatments against each other and placebo.
Fifty one patients (33 women, 18 men) diagnosed with lateral epicondylitis were included to the study. Patients were randomised to continuous ultrasound (n=17), pulsed ultrasound (n=17) and placebo (n=17) groups by using closed envelop method. First group received 10 sessions of 1 W/cm2 and 1,5 MHz continuous ultrasound treatment. Second group received 10 sessions of 1 W/cm2 and 1,5 MHz pulsed ultrasound treatment in proportion as 1:4. Third group received 10 sessions of placebo treatment with the same device seemed to be working but without delivering any output. Resting and moving pain levels of the patients were evaluated by using visual analog scale. Muscle strength was evaluated by using dynamometer. For functional evaluation Duruoz's hand index and Patient-Rated Tennis Elbow Evaluation (PRTEE) scales were used. Evaluations were made at baseline, at the end of the therapy, and one month after the therapy. In addition, at baseline and at the end of the therapy, the thickness of the common extensor tendon was measured by using ultrasonic imaging (USG).
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
- Double (Participant, Investigator)
盲法说明
the patients and the physician was blind to the study
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
- •aged between 18-70 years
- •pain on the lateral side of the elbow for less than six months
- •tenderness over the lateral epicondyle
- •pain during extension of wrist and fingers
排除标准
- •upper extremity and neck disorders
- •other elbow pathologies
- •presence of tendon rupture
- •usage of non-steroidal anti inflammatory drugs
- •joint limitations due to a previous radius/ulna fracture
- •previous elbow surgery
- •osteoporosis, malignancy, hemophilia, neurologic deficit(s) in the ipsilateral upper limb
- •cognitive disfunction
研究组 & 干预措施
continuous ultrasound
continuous ultrasound were applied to the patients
干预措施: ultrasound (Device)
pulsed ultrasound
pulsed ultrasound were applied to the patients
干预措施: ultrasound (Device)
placebo
placebo (sham) ultrasound were applied to the patients
干预措施: ultrasound (Device)
结局指标
主要结局
measuring the thickness of common extensor tendon by ultrasound imaging.
时间窗: 2nd week
the thickness of common extensor tendon by ultrasound imaging was measured at the beginning and at the end of the study
次要结局
- Visual Analog Scale(6th week)
- Duruoz's hand index(6th week)
- Patient-Rated Tennis Elbow Evaluation (PRTEE) scales(6th week)
研究者
Onur Armağan
Onur Armagan, medical doctor
Eskisehir Osmangazi University