High-Intensity Laser Therapy in Carpal Tunnel Syndrome: Clinical, Sonographic, and Electrophysiological Outcomes

Официальное название

Evaluation of the Clinical, Sonographic, and Electrophysiological Efficacy of High-Intensity Laser Therapy (HILT) in Carpal Tunnel Syndrome

Обзор

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.

Подробное описание

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.

* Clinical Assessment: Pain intensity (Visual Analog Scale - VAS), symptom severity and functional status (Boston Carpal Tunnel Questionnaire - BCTQ), gross grip strength (Hand Dynamometer), and pinch strength (Pinchmeter) . * Ultrasonographic Assessment: Measurement of the median nerve Cross-Sectional Area (CSA) at the proximal carpal tunnel inlet. * Electrophysiological Assessment: Sensory and motor nerve conduction studies of the median nerve (evaluating distal latency, conduction velocity, and amplitude).

This study aims to demonstrate the multifaceted contribution (clinical, anatomical, and physiological) of HILT to nerve recovery by reducing edema and inflammation in the pathophysiology of CTS.

Вмешательства

• Устройство High-Intensity Laser Therapy (HILT)
  Procedure: The laser is applied to the carpal tunnel area while the patient's forearm is in supination. Device Specifications: Pulsed Nd:YAG laser source with Peak Power \>3000 W, Intensity (max) 15,000 W/cm², Frequency 10-30 Hz, Pulse duration ≤ 100 μs, and a spot size of 0.5 cm diameter (0.2 cm²). Treatment Protocol (3 Phases): 1. Initial Rapid Scan (3 Steps): Step 1: 25 Hz, 510 mJ/cm², 139 J energy. Step 2: 20 Hz, 610 mJ/cm², 139 J energy. Step 3: 19 Hz, 710 mJ/cm², 139 J energ
• Устройство Sham High-Intensity Laser Therapy
  The same HIRO TT device is used with the same positioning and duration as the experimental group. The device provides auditory and visual cues identical to the active treatment, but no laser energy is emitted to the tissue. Participants will also use a standard wrist splint.

Первичные конечные точки

• Pain Severity assessed by Visual Analog Scale (VAS) [Срок оценки: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.]
• Symptom Severity and Functional Status assessed by Boston Carpal Tunnel Questionnaire (BCTQ) [Срок оценки: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.]

Вторичные конечные точки (9)

• Median Nerve Cross-Sectional Area(CSA) [Срок оценки: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period]
• Hand Grip Strength [Срок оценки: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.]
• Pinch Strength (Lateral Pinch) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ankara Bilkent City Hospital — Ankara

Публикации

• Yigit F, Ordahan B. Effects of high-intensity laser therapy on pain, functional status, hand grip strength, and median nerve cross-sectional area by ultrasonography in patients with carpal tunnel syndrome. Lasers Med Sci. 2023 Oct 31;38(1):248. doi: 10.1007/s10103-023-03913-z. PMID 37906312
• de la Barra Ortiz HA, Avila MA, Parizotto NA, Liebano RE. A systematic review and meta-analysis of the effectiveness of high-intensity laser therapy in patients with carpal tunnel syndrome. Physiotherapy. 2025 Sep;128:101780. doi: 10.1016/j.physio.2025.101780. Epub 2025 Mar 5. PMID 40121869

Идентификаторы

NCT: NCT07414069 · 1-24-647

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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