Carpal Tunnel Syndrome (CTS)
Conditions
Keywords
Low-level laser therapy, Carpal tunnel syndrome, Paraffin bath therapy, median nerve ultrasonography, median nerve conduction study
Brief summary
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.
Interventions
Active 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)
DEVICEParaffin Bath Therapy
The 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)
The 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)
All 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)
Sponsors
Bursa Yuksek Ihtisas Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Clinical assessments, grip/pinch strength measurements, ultrasonographic examinations, and electrophysiological studies will be performed by assessors blinded to treatment allocation. Participants in the active LLLT and sham LLLT arms will be blinded to their allocation, as identical devices, application sites, and session durations will be used; however, full participant blinding across all three arms is not feasible due to the clearly distinguishable nature of paraffin bath therapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Cardiac pacemaker (contraindication to physical therapy and electrodiagnostic studies) * Prior wrist fracture or laceration at the treatment site * Injection therapy for CTS within the past 3 months * Prior CTS surgery with recurrence * Active malignancy under treatment * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (SSS) | Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion | 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) | Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Median Sensory Nerve Action Potential Amplitude | Before treatment and 3 months after treatment completion | Assessed via median sensory nerve conduction study. Unit of Measure: microvolts (µV) |
| Change from Baseline in Median Sensory Nerve Conduction Velocity | Before treatment and 3 months after treatment completion | Assessed via median sensory nerve conduction study. Unit of Measure: meters/second (m/s) |
| Change from Baseline in Median Sensory Distal Latency | Before treatment and 3 months after treatment completion | Assessed via median sensory nerve conduction study. Unit of Measure: milliseconds (ms) |
| Change from Baseline in Median Motor Compound Muscle Action Potential Amplitude | Before treatment and 3 months after treatment completion | Assessed via median motor nerve conduction study. Unit of Measure: millivolts (mV) |
| Change from Baseline in Median Motor Nerve Conduction Velocity | Before treatment and 3 months after treatment completion | Assessed via median motor nerve conduction study. Unit of Measure: meters/second (m/s) |
| Change from Baseline in Median Motor Distal Latency | Before treatment and 3 months after treatment completion | Assessed via median motor nerve conduction study. Unit of Measure: milliseconds (ms) |
| Change from Baseline in Median Nerve Cross-Sectional Area (Ultrasonography) | Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion | Median nerve cross-sectional area, transverse diameters, intraneural vascularity, echogenicity, and palmar bowing will be assessed by ultrasonography. Unit of Measure: square millimeters (mm²) |
| Change from Baseline in Grip Strength | Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion | Assessed using a Jamar hydraulic hand dynamometer, following American Society of Hand Therapists (ASHT) recommendations. The mean of three trials will be used. Unit of Measure: kilograms (kg) |
| Change from Baseline in Pinch Strength (Tip, Tripod, and Tip-to-Tip Pinch) | Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion | Assessed using a pinch gauge for tip pinch (lateral pinch), tripod pinch (3-jaw chuck), and tip-to-tip pinch. The mean of three trials for each pinch type will be used. Unit of Measure: kilograms (kg) |
| Change from Baseline in Pain (Visual Analog Scale) | Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion | Pain intensity will be assessed using a 0-10 cm Visual Analog Scale, with higher scores indicating greater pain intensity. Unit of Measure: score on a scale (0-10) |
| Change from Baseline in QuickDASH Score | Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion | Upper extremity function will be assessed using the Turkish-validated QuickDASH questionnaire, with higher scores indicating greater disability. Unit of Measure: score on a scale (0-100) |
Countries
Turkey (Türkiye)
Contacts
CONTACTSinem Akselim
Outcome results
None listed