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.
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
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)
Parallel
High-Intensity Laser Therapy (HILT)
DeviceProcedure: 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 energy. 2. Trigger Point Phase: Applied to painful points on the affected side. Step 1: 15 Hz, 360 mJ/cm², 6.3 J energy. Step 2: 15 Hz, 510 mJ/cm², 9 J energy. Step 3: 14 Hz, 610 mJ/cm², 10.1 J energy (applied for 6 seconds per point). 3. Final Slow Scan: Performed using the same parameters as the rapid scan phase. Total Energy: A total of 835 Joules is delivered per session.
Sham High-Intensity Laser Therapy
DeviceThe 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.
Pain Severity assessed by Visual Analog Scale (VAS)
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)
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).
Median Nerve Cross-Sectional Area(CSA)
The cross-sectional area of the median nerve will be measured by ultrasonography at the proximal carpal tunnel level. In Carpal Tunnel Syndrome (CTS), the nerve typically swells due to edema and inflammation. A decrease in the cross-sectional area indicates a positive response to treatment. Unit of Measure: Square millimeters (mm²) Interpretation: Lower values indicate a better clinical outcome (reduction in nerve edema).BE
Hand Grip Strength
Evaluation of the maximum isometric strength of the hand and forearm muscles using a hydraulic hand dynamometer (Baseline® hydraulic LCD hand dynamometer). The measurement is performed with the patient seated, elbow flexed at 90 degrees and wrist in a neutral position. The average of three measurements is recorded. Interpretation: Higher scores indicate a better outcome. An increase in grip strength suggests improved muscular function and a reduction in the inhibitory effects of pain and nerve compression caused by Carpal Tunnel Syndrome. Unit of Measure: Kilograms (kg)
Pinch Strength (Lateral Pinch)
Description: Evaluation of the strength of the pinch between the thumb and the index finger using a hydraulic pinch gauge (Baseline® hydraulic LCD pinch gauge). Lateral pinch is measured by asking the patient to press between the pad of the thumb and the lateral aspect of the index finger. Interpretation: Higher scores indicate a better outcome. Improved pinch strength reflects better coordination and strength of the intrinsic hand muscles innervated by the median nerve. Unit of Measure: Kilograms (kg)
Median Nerve Motor Distal Latency (MDL)
Evaluation of the motor component of the median nerve using an Electroneuromyography (ENMG) device (Nihon Kohden Neuropack 2). MDL reflects the time taken for an electrical impulse to travel from the wrist to the thenar muscle. Unit of Measure: Milliseconds (ms) Interpretation: Lower scores (shorter latency) indicate a better outcome. A decrease in latency suggests improved nerve conduction across the carpal tunnel, reflecting a reduction in nerve compression.
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