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.
Diagnosis of mild-to-moderate carpal tunnel syndrome (unilateral or bilateral), confirmed by paresthesia and pain in the median nerve distribution, positive Tinel's and Phalen's signs on physical examination, and electrophysiologically confirmed mild-to-moderate CTS
Age 18 years or older
No cognitive impairment
Provision of informed consent to participate in the study
Cognitive impairment
Severe-stage CTS with surgery planned
Neurological disease affecting the extremity with CTS
Active local infection at the treatment site (e.g., cellulitis, erysipelas, thrombophlebitis) contraindicating physical therapy
Parallel
Low-Level Laser Therapy (LLLT)
DeviceActive LLLT applied at 670 nm wavelength at 5 points along the carpal tunnel and flexor retinaculum at the wrist level, delivering 0.8 J per point (4 J per session), administered once daily, 5 days/week, for 3 weeks (15 sessions total). Arms assigned: Arm 1 (LLLT Group)
Paraffin Bath Therapy
DeviceThe hand is dipped into a container of melted paraffin, removed, and the paraffin layer is left in place for approximately 20 minutes before being peeled off. Administered once daily, 5 days/week, for 3 weeks (15 sessions total). Arms assigned: Arm 2 (Paraffin Group)
Sham Low-Level Laser Therapy
DeviceThe same laser device, application sites, and session duration as active LLLT will be used, but without therapeutic energy output, administered once daily, 5 days/week, for 3 weeks (15 sessions total). Arms assigned: Arm 3 (Sham LLLT Group)
Standard Conservative Care
Other interventionAll participants will continue a home exercise program consisting of tendon and median nerve gliding exercises, along with regular use of a night wrist splint, from enrollment until the final study assessment. Arms assigned: Arm 1, Arm 2, Arm 3 (all arms)
Change from Baseline in Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (SSS)
Symptom severity will be assessed using the Turkish-validated Symptom Severity Scale of the Boston Carpal Tunnel Questionnaire. Higher scores indicate greater symptom severity. Unit of Measure: score
Change from Baseline in Boston Carpal Tunnel Questionnaire - Functional Status Scale (FSS)
Functional status will be assessed using the Turkish-validated Functional Status Scale of the Boston Carpal Tunnel Questionnaire. Higher scores indicate greater functional impairment. Unit of Measure: score
Change from Baseline in Median Sensory Nerve Action Potential Amplitude
Assessed via median sensory nerve conduction study. Unit of Measure: microvolts (µV)
Change from Baseline in Median Sensory Nerve Conduction Velocity
Assessed via median sensory nerve conduction study. Unit of Measure: meters/second (m/s)
Change from Baseline in Median Sensory Distal Latency
Assessed via median sensory nerve conduction study. Unit of Measure: milliseconds (ms)
Change from Baseline in Median Motor Compound Muscle Action Potential Amplitude
Assessed via median motor nerve conduction study. Unit of Measure: millivolts (mV)
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