Low-Level Laser Therapy for Carpal Tunnel Syndrome

NCT07788248 | Not Yet Recruiting

• 1 other identifier: 2024-KAEK-13 2026-10/11
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Low-level laser therapy; Carpal tunnel syndrome; Paraffin bath therapy; median nerve ultrasonography; median nerve conduction study

Outcome Measures

Primary Outcomes (2)

• 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

  Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion

• 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

  Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion

Secondary Outcomes (11)

• Change from Baseline in Median Sensory Nerve Action Potential Amplitude

  Before treatment and 3 months after treatment completion

• Change from Baseline in Median Sensory Nerve Conduction Velocity

  Before treatment and 3 months after treatment completion

• Change from Baseline in Median Sensory Distal Latency

  Before treatment and 3 months after treatment completion

• Change from Baseline in Median Motor Compound Muscle Action Potential Amplitude

  Before treatment and 3 months after treatment completion

• Change from Baseline in Median Motor Nerve Conduction Velocity

  Before treatment and 3 months after treatment completion

Study Arms (3)

Experimental: LLLT Group

EXPERIMENTAL

Participants in this arm will receive active low-level laser therapy in addition to standard conservative care (night wrist splinting and home exercise program).

Device: Low-Level Laser Therapy (LLLT); Other: Standard Conservative Care

Active Comparator: Paraffin Group

ACTIVE COMPARATOR

Participants in this arm will receive paraffin bath therapy in addition to standard conservative care (night wrist splinting and home exercise program).

Device: Paraffin Bath Therapy; Other: Standard Conservative Care

Sham Comparator: Sham LLLT Group

SHAM COMPARATOR

Participants in this arm will receive sham low-level laser therapy (identical device, duration, and application sites, without therapeutic energy output) in addition to standard conservative care (night wrist splinting and home exercise program).

Device: Sham Low-Level Laser Therapy; Other: Standard Conservative Care

Interventions

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)

Also known as: Zirvemed paraffin device

Active Comparator: Paraffin Group

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)

Active Comparator: Paraffin Group; Experimental: LLLT Group; Sham Comparator: Sham LLLT Group

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)

Also known as: BTL LLLT device

Experimental: LLLT Group

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)

Also known as: Sham BTL LLLT device

Sham Comparator: Sham LLLT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

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

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Sinem Akselim

CONTACT

+905336391332; sinemakselim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)