Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07414069

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

Led by Ankara City Hospital Bilkent · Updated on 2026-02-17

80

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ankara Bilkent City Hospital

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

Actively Recruiting

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Research Team

C

Ceren FINDIK KILIÇ

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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