RecruitingNot ApplicableNCT07414069

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

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


Sponsor

Ankara City Hospital Bilkent

Enrollment

80 participants

Start Date

Nov 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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

Exclusion Criteria8

  • 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

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Interventions

DEVICEHigh-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.

DEVICESham 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.


Locations(1)

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, Turkey (Türkiye)

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NCT07414069


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