Evaluation of the Clinical, Sonographic, and Electrophysiological Efficacy of High-Intensity Laser Therapy (HILT) in Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Severity assessed by Visual Analog Scale (VAS)
研究概览
简要总结
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper extremity and is characterized by pain, paresthesia, and functional impairment resulting from increased pressure within the carpal tunnel. Although conservative treatment approaches such as splinting and pharmacological therapy are commonly used, High-Intensity Laser Therapy (HILT) has emerged as a non-invasive modality with potential analgesic, anti-inflammatory, and biostimulatory effects. However, evidence regarding its efficacy remains limited, particularly from sham-controlled studies incorporating objective outcome measures. This prospective, randomized, double-blind, sham-controlled clinical trial aims to evaluate the clinical, sonographic, and electrophysiological effectiveness of HILT in patients with mild-to-moderate CTS. Eligible patients aged 18 to 65 years with electrophysiologically confirmed mild-to-moderate CTS will be randomized into two groups: a HILT group and a sham HILT group. Both groups will receive standard wrist splinting as part of conservative management. Clinical outcomes will be assessed using Visual Analog Scale (VAS) scores for pain, Boston Carpal Tunnel Questionnaire (BCTQ) scores for symptom severity and functional status, and grip strength measurements. Objective evaluations will include median nerve sensory and motor nerve conduction studies and ultrasonographic measurement of the median nerve cross-sectional area at the proximal carpal tunnel level. Assessments will be performed at baseline and at 1 and 3 months after treatment. This study aims to provide robust and objective evidence regarding the therapeutic effectiveness of HILT in the conservative management of carpal tunnel syndrome.
详细描述
Carpal Tunnel Syndrome (CTS) is the most common entrapment neuropathy of the upper extremity, characterized by the compression of the median nerve due to increased pressure within the carpal tunnel. While conservative management strategies such as splinting and physical therapy modalities are the standard approach, High-Intensity Laser Therapy (HILT) has recently emerged as a potent, non-invasive therapeutic option . Utilizing an Nd:YAG laser source, HILT penetrates deep tissues to induce photochemical and photothermal effects. It is hypothesized to promote tissue repair by increasing ATP synthesis at the mitochondrial level, regulating Na/K pump activity, and providing analgesia by suppressing inflammatory mediators .
Although HILT is used in clinical practice, there is a scarcity of sham-controlled, double-blind studies that comprehensively evaluate its efficacy using a combination of clinical, electrophysiological, and ultrasonographic (median nerve cross-sectional area) parameters .
Study Objective: The primary objective of this prospective, randomized, double-blind, sham-controlled trial is to provide evidence-based data on the efficacy of HILT regarding pain, hand function, grip strength, nerve conduction velocities, and median nerve morphology (ultrasonographic cross-sectional area) in patients with mild-to-moderate CTS.
Study Population and Design: Patients aged 18-65 years presenting to the Physical Therapy Clinic with clinically and electrophysiologically confirmed 80 patient hand mild-to-moderate CTS will be recruited.
Outcome Measures and Timeline: Assessments will be performed by independent blinded researchers at Baseline, Month 1, and Month 3 post-treatment.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Clinical symptoms consistent with carpal tunnel syndrome
- •Electrophysiologically confirmed mild or moderate carpal tunnel syndrome
- •Ability to comply with the study protocol and follow-up assessments
- •Provided written informed consent
排除标准
- •Severe carpal tunnel syndrome on electrophysiological examination
- •Previous surgical treatment for carpal tunnel syndrome
- •Local causes of carpal tunnel syndrome (e.g., mass lesions, ganglion cysts, tumors)
- •Systemic conditions associated with carpal tunnel syndrome (e.g., diabetes mellitus, hypothyroidism, pregnancy, acromegaly)
- •History of corticosteroid injection for carpal tunnel syndrome within the last 6 months
- •Presence of polyneuropathy, radiculopathy, or other upper extremity peripheral nerve disorders
- •Contraindications to electrophysiological testing or laser therapy
- •Inability to complete follow-up assessments
研究组 & 干预措施
High-Intensity Laser Therapy (HILT)
Patients in this group will receive High-Intensity Laser Therapy (HILT) in addition to using a neutral wrist splint. The treatment will consist of a total of 10 sessions, administered 5 days per week for a duration of 2 weeks.
干预措施: High-Intensity Laser Therapy (HILT) (Device)
Sham High-Intensity Laser Therapy
Patients in this group will receive sham (placebo) laser therapy in addition to using a neutral wrist splint. The treatment will consist of a total of 10 sessions, administered 5 days per week for a duration of 2 weeks.
干预措施: Sham High-Intensity Laser Therapy (Device)
结局指标
主要结局
Pain Severity assessed by Visual Analog Scale (VAS)
时间窗: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Pain intensity will be evaluated using the Visual Analog Scale (VAS). This is a self-reported scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "severe pain". Higher scores indicate a worse outcome (greater pain intensity).
Symptom Severity and Functional Status assessed by Boston Carpal Tunnel Questionnaire (BCTQ)
时间窗: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
The BCTQ consists of two subscales: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). The SSS has 11 items and the FSS has 8 items. Each item is scored on a scale from 1 to 5, where 1 indicates "no symptoms/no difficulty" and 5 indicates "severe symptoms/cannot perform activity". The final score is calculated as the mean of the items. Higher scores indicate a worse outcome (more severe symptoms and greater functional impairment).
次要结局
- Median Nerve Cross-Sectional Area(CSA)(At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period)
- Hand Grip Strength(At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.)
- Pinch Strength (Lateral Pinch)(Time Frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.)
- Median Nerve Motor Distal Latency (MDL)(At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.)
- Median Nerve Compound Muscle Action Potential (CMAP) Amplitude(At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.)
- Median Nerve Sensory Conduction Velocity (Palmar)(At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.)
- Median Nerve Sensory Conduction Velocity (SCV)(Digit 2)(At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.)
- Median Nerve Sensory Action Potential (SNAP) Amplitude (Palmar)(At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.)
- Median Nerve Sensory Action Potential (SNAP) Amplitude (Digit 2)(At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.)