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

NCT07414069 | Recruiting

• 1 other identifier: 1-24-647
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Carpal Tunnel Syndrome; High-Intensity Laser Therapy; HILT; Entrapment Neuropathy; Median Nerve

Outcome Measures

Primary Outcomes (2)

• 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).

  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)

  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).

  At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.

Secondary Outcomes (9)

• 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.

Study Arms (2)

High-Intensity Laser Therapy (HILT)

EXPERIMENTAL

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.

Device: High-Intensity Laser Therapy (HILT)

Sham High-Intensity Laser Therapy

SHAM COMPARATOR

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.

Device: Sham High-Intensity Laser Therapy

Interventions

High-Intensity Laser Therapy (HILT) DEVICE

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.

High-Intensity Laser Therapy (HILT)

Sham High-Intensity Laser Therapy DEVICE

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.

Sham High-Intensity Laser Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Charcot-Marie-Tooth Disease

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Filiz Eser, professor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ceren FINDIK KILIÇ

CONTACT

+905312689928; crn.fndk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two parallel groups: a High-Intensity Laser Therapy (HILT) group or a sham HILT group. Both groups will receive standard wrist splinting as part of conservative management. Outcomes will be assessed and compared between groups at predefined time points.

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 17, 2026
• Study Start: November 2, 2025
• Primary Completion: March 5, 2026
• Study Completion: April 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)