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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Ankara Bilkent City Hospital
RECRUITING
Ankara
Contact Information
Primary
Ceren FINDIK KILIÇ
crn.fndk@gmail.com
+905312689928
Time Frame
Start Date: 2025-11-02
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 80
Treatments
Experimental: High-Intensity Laser Therapy (HILT)
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.
Sham_comparator: Sham High-Intensity Laser Therapy
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.
Sponsors
Leads: Ankara City Hospital Bilkent

This content was sourced from clinicaltrials.gov