High-Intensity Laser Therapy in Carpal Tunnel Syndrome: Clinical, Sonographic, and Electrophysiological Outcomes
Trial Parameters
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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