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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Carpal Tunnel Syndrome

In brief

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.

Key facts

Study ID: NCT07414069
Run by: Ankara City Hospital Bilkent
People needed: 80
Starts: 2025-11-02
Expected to finish: 2026-04-30
Last updated by the study team: 2026-02-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Ankara Bilkent City Hospital — Ankara, Ankara, Çankaya, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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