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

Summary

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.

Conditions

• Carpal Tunnel Syndrome

Interventions

DEVICE

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 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.

DEVICE

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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent

  lead OTHER

Principal Investigators

• Filiz Eser, professor · Ankara City Hospital Bilkent

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-02

Primary Completion

2026-03-05

Completion

2026-04-30

Countries

• Turkey (Türkiye)

Study Locations