Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07788248 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Low-Level Laser Therapy for Carpal Tunnel Syndrome

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy, caused by compression of the median nerve within the carpal tunnel at the wrist. It typically presents with paresthesia, numbness, and pain in the median nerve distribution, and in advanced cases may lead to thenar atrophy and reduced grip strength. Conservative treatment options for mild-to-moderate CTS include wrist splinting, exercise programs, and physical therapy modalities such as low-level laser therapy (LLLT) and paraffin bath therapy; however, the comparative efficacy of these modalities has not been well established. This study aims to compare the efficacy of low-level laser therapy (LLLT), paraffin bath therapy, and sham LLLT, each combined with standard conservative care (night wrist splinting and tendon/nerve gliding exercises), in patients with mild-to-moderate CTS. Participants will be randomly assigned in a 1:1:1 ratio to receive LLLT, paraffin bath therapy, or sham LLLT, each administered 5 days/week for 3 weeks (15 sessions), in addition to wrist splinting and a home exercise program continued throughout the study. The primary outcome is the change in symptom severity and functional status, assessed using the Symptom Severity Scale (SSS) and Functional Status Scale (FSS) of the Boston Carpal Tunnel Questionnaire. Secondary outcomes include electrophysiological parameters from median nerve conduction studies, median nerve cross-sectional area on ultrasonography, grip and pinch strength, pain (Visual Analog Scale), and hand function (QuickDASH). Assessments will be performed before treatment, immediately after completing 15 sessions, and at 3 months after treatment completion. Outcome assessors will be blinded to treatment allocation. The investigators hypothesize that LLLT will result in greater improvement in clinical, electrophysiological, and morphological parameters compared with sham LLLT, and will provide comparative data on its efficacy relative to paraffin bath therapy.
Trial Details
NCT Number NCT07788248
Lead Sponsor Bursa Yuksek Ihtisas Training and Research Hospital
Conditions
(from sponsor)
Carpal Tunnel Syndrome (CTS)
Related terms Carpal Tunnel Syndrome
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov