The Effect of High-intensity Laser Therapy on Pain, Functional Status, Hand Grip Strength and Median Nerve Cross-sectional Area in Ultrasonography in Patients With Carpal Tunnel Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on pain, functional status, hand grip strength and median nerve cross-sectional area in ultrasonography in patients with carpal tunnel syndrome.
详细描述
Patients who are admitted and diagnosed with carpal tunnel syndrome based on anamnesis, physical examination and electromyography are included in the study.
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)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Electrophysiologically mild or moderate CTS
- •Patients who are literate and able to understand verbal instructions in our
排除标准
- •Systemic disorders that may affect treatment such as hypothyroidism, SLE, gout
- •History of polyneuropathy, cervical radiculopathy, brachial plexopathy
- •Injection for the carpal tunnel in the last 1 month
- •History of severe trauma, fracture, operation to both upper extremities at any time
- •Malignancy or history of malignancy
- •Renal failure
- •Peripheral or central nervous system diseases
- •History of physical therapy program for the same hand wrist in the last months.
研究组 & 干预措施
A hot laser derived from a Nd: YAG laser
HILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the hand wrist area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first five sessions consisted of a 100-second intermittent phase analgesic effect at 8 W and 8 J/cm2 for a total energy of 200 J. The following five sessions consisted of a continuous 11 minutes 6 second bio stimulating effect with a dosage of 3 W 80 J/cm2. Over the course of two weeks, ten treatment sessions of HILT will be given.
干预措施: high-intensity laser therapy (Device)
A hot laser derived from a Nd: YAG laser
HILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the hand wrist area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first five sessions consisted of a 100-second intermittent phase analgesic effect at 8 W and 8 J/cm2 for a total energy of 200 J. The following five sessions consisted of a continuous 11 minutes 6 second bio stimulating effect with a dosage of 3 W 80 J/cm2. Over the course of two weeks, ten treatment sessions of HILT will be given.
干预措施: sham high-intensity laser therapy (Device)
sham high-intensity laser therapy
HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions.
干预措施: high-intensity laser therapy (Device)
sham high-intensity laser therapy
HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions.
干预措施: sham high-intensity laser therapy (Device)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Change from baseline in pain on the VAS at week 2 and week 12 [ Time Frame: Baseline-Week 2- Week 12 ]
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain.
次要结局
- The cross-sectional area of the median nerve(Change from baseline in the cross-sectional area of the median nerve at week 2 and week 12.)
- Boston Carpal Tunnel Questionnaire(Change from baseline in pain and disability on the Boston Carpal Tunnel Questionnaire at week 2 and 12.)
- Hand Grip Force Measurement Test(Baseline- week 2- week 12)
研究者
Banu Ordahan
Clinical Professor
Necmettin Erbakan University