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NCT Number: NCT07788248

Low-Level Laser Therapy for Carpal Tunnel Syndrome

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.

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location contact

Sinem Akselim

CONTACT

[email protected]

+905336391332

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-level laser therapy (LLLT)

Device

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)

Other names: BTL LLLT device

Paraffin Bath Therapy

Device

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)

Other names: Zirvemed paraffin device

Sham Low-Level Laser Therapy

Device

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)

Other names: Sham BTL LLLT device

Standard Conservative Care

Other

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)

Primary outcomes

  1. Change from Baseline in Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (SSS)

    Time frame: 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

  2. Change from Baseline in Boston Carpal Tunnel Questionnaire - Functional Status Scale (FSS)

    Time frame: 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 outcomes

  1. Change from Baseline in Median Sensory Nerve Action Potential Amplitude

    Time frame: Before treatment and 3 months after treatment completion

    Assessed via median sensory nerve conduction study. Unit of Measure: microvolts (µV)

  2. Change from Baseline in Median Sensory Nerve Conduction Velocity

    Time frame: Before treatment and 3 months after treatment completion

    Assessed via median sensory nerve conduction study. Unit of Measure: meters/second (m/s)

  3. Change from Baseline in Median Sensory Distal Latency

    Time frame: Before treatment and 3 months after treatment completion

    Assessed via median sensory nerve conduction study. Unit of Measure: milliseconds (ms)

  4. Change from Baseline in Median Motor Compound Muscle Action Potential Amplitude

    Time frame: Before treatment and 3 months after treatment completion

    Assessed via median motor nerve conduction study. Unit of Measure: millivolts (mV)

  5. Change from Baseline in Median Motor Nerve Conduction Velocity

    Time frame: Before treatment and 3 months after treatment completion

    Assessed via median motor nerve conduction study. Unit of Measure: meters/second (m/s)

  6. Change from Baseline in Median Motor Distal Latency

    Time frame: Before treatment and 3 months after treatment completion

    Assessed via median motor nerve conduction study. Unit of Measure: milliseconds (ms)

  7. Change from Baseline in Median Nerve Cross-Sectional Area (Ultrasonography)

    Time frame: 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)

  8. Change from Baseline in Grip Strength

    Time frame: 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)

  9. Change from Baseline in Pinch Strength (Tip, Tripod, and Tip-to-Tip Pinch)

    Time frame: 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)

  10. Change from Baseline in Pain (Visual Analog Scale)

    Time frame: 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)

  11. Change from Baseline in QuickDASH Score

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sinem Akselim

CONTACT

[email protected]

+905336391332

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Efficacy of Low-Level Laser Therapy on Symptom Severity, Functionality, Ultrasonographic and Electrophysiological Parameters in Carpal Tunnel Syndrome: A Randomized, Sham-Controlled, Assessor-Blind Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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