Carpal Tunnel SyndromeNCT07414069
High-Intensity Laser Therapy in Carpal Tunnel Syndrome: Clinical, Sonographic, and Electrophysiological Outcomes
A study testing High-Intensity Laser Therapy (HILT) in people with Carpal Tunnel Syndrome, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper extremity and is characterized by pain, paresthesia, and functional impairment resulting from increased pressure within the carpal tunnel. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- High-Intensity Laser Therapy (HILT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Clinical symptoms consistent with carpal tunnel syndrome
- Electrophysiologically confirmed mild or moderate carpal tunnel syndrome
- Ability to comply with the study protocol and follow-up assessments
- Provided written informed consent
Who cannot join
- Severe carpal tunnel syndrome on electrophysiological examination
- Previous surgical treatment for carpal tunnel syndrome
- Local causes of carpal tunnel syndrome (e.g., mass lesions, ganglion cysts, tumors)
- Systemic conditions associated with carpal tunnel syndrome (e.g., diabetes mellitus, hypothyroidism, pregnancy, acromegaly)
- History of corticosteroid injection for carpal tunnel syndrome within the last 6 months
- Presence of polyneuropathy, radiculopathy, or other upper extremity peripheral nerve disorders
- Contraindications to electrophysiological testing or laser therapy
- Inability to complete follow-up assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Ankara, Çankaya, 06800
Filiz Eser, +905067388171, filizeser@gmail.com
About this study
Official title: Evaluation of the Clinical, Sonographic, and Electrophysiological Efficacy of High-Intensity Laser Therapy (HILT) in Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper extremity and is characterized by pain, paresthesia, and functional impairment resulting from increased pressure within the carpal tunnel. Although conservative treatment approaches such as splinting and pharmacological therapy are commonly used, High-Intensity Laser Therapy (HILT) has emerged as a non-invasive modality with potential analgesic, anti-inflammatory, and biostimulatory effects. However, evidence regarding its efficacy remains limited, particularly from sham-controlled studies incorporating objective outcome measures. This prospective, randomized, double-blind, sham-controlled clinical trial aims to evaluate the clinical, sonographic, and electrophysiological effectiveness of HILT in patients with mild-to-moderate CTS. Eligible patients aged 18 to 65 years with electrophysiologically confirmed mild-to-moderate CTS will be randomized into two groups: a HILT group and a sham HILT group. Both groups will receive standard wrist splinting as part of conservative management. Clinical outcomes will be assessed using Visual Analog Scale (VAS) scores for pain, Boston Carpal Tunnel Questionnaire (BCTQ) scores for symptom severity and functional status, and grip strength measurements. Objective evaluations will include median nerve sensory and motor nerve conduction studies and ultrasonographic measurement of the median nerve cross-sectional area at the proximal carpal tunnel level. Assessments will be performed at baseline and at 1 and 3 months after treatment. This study aims to provide robust and objective evidence regarding the therapeutic effectiveness of HILT in the conservative management of carpal tunnel syndrome.
Read the detailed description
Carpal Tunnel Syndrome (CTS) is the most common entrapment neuropathy of the upper extremity, characterized by the compression of the median nerve due to increased pressure within the carpal tunnel. While conservative management strategies such as splinting and physical therapy modalities are the standard approach, High-Intensity Laser Therapy (HILT) has recently emerged as a potent, non-invasive therapeutic option . Utilizing an Nd:YAG laser source, HILT penetrates deep tissues to induce photochemical and photothermal effects. It is hypothesized to promote tissue repair by increasing ATP synthesis at the mitochondrial level, regulating Na/K pump activity, and providing analgesia by suppressing inflammatory mediators .
Although HILT is used in clinical practice, there is a scarcity of sham-controlled, double-blind studies that comprehensively evaluate its efficacy using a combination of clinical, electrophysiological, and ultrasonographic (median nerve cross-sectional area) parameters .
Study Objective: The primary objective of this prospective, randomized, double-blind, sham-controlled trial is to provide evidence-based data on the efficacy of HILT regarding pain, hand function, grip strength, nerve conduction velocities, and median nerve morphology (ultrasonographic cross-sectional area) in patients with mild-to-moderate CTS.
Study Population and Design: Patients aged 18-65 years presenting to the Physical Therapy Clinic with clinically and electrophysiologically confirmed 80 patient hand mild-to-moderate CTS will be recruited.
Outcome Measures and Timeline: Assessments will be performed by independent blinded researchers at Baseline, Month 1, and Month 3 post-treatment.
- Clinical Assessment: Pain intensity (Visual Analog Scale - VAS), symptom severity and functional status (Boston Carpal Tunnel Questionnaire - BCTQ), gross grip strength (Hand Dynamometer), and pinch strength (Pinchmeter) .
- Ultrasonographic Assessment: Measurement of the median nerve Cross-Sectional Area (CSA) at the proximal carpal tunnel inlet.
- Electrophysiological Assessment: Sensory and motor nerve conduction studies of the median nerve (evaluating distal latency, conduction velocity, and amplitude).
This study aims to demonstrate the multifaceted contribution (clinical, anatomical, and physiological) of HILT to nerve recovery by reducing edema and inflammation in the pathophysiology of CTS.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- High-Intensity Laser Therapy (HILT), Sham High-Intensity Laser Therapy
- Keywords
- Carpal Tunnel Syndrome, High-Intensity Laser Therapy, HILT, Entrapment Neuropathy, Median Nerve
- Medical subject headings
- Carpal Tunnel Syndrome, Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Laser Therapy (HILT)Device
Procedure: The laser is applied to the carpal tunnel area while the patient's forearm is in supination.
Device Specifications: Pulsed Nd:YAG laser source with Peak Power >3000 W, Intensity (max) 15,000 W/cm², Frequency 10-30 Hz, Pulse duration ≤ 100 μs, and a spot size of 0.5 cm diameter (0.2 cm²).
Treatment Protocol (3 Phases):
- Initial Rapid Scan (3 Steps): Step 1: 25 Hz, 510 mJ/cm², 139 J energy. Step 2: 20 Hz, 610 mJ/cm², 139 J energy. Step 3: 19 Hz, 710 mJ/cm², 139 J energy.
- Trigger Point Phase: Applied to painful points on the affected side. Step 1: 15 Hz, 360 mJ/cm², 6.3 J energy. Step 2: 15 Hz, 510 mJ/cm², 9 J energy. Step 3: 14 Hz, 610 mJ/cm², 10.1 J energy (applied for 6 seconds per point).
- Final Slow Scan: Performed using the same parameters as the rapid scan phase.
Total Energy: A total of 835 Joules is delivered per session.
Sham High-Intensity Laser TherapyDevice
The same HIRO TT device is used with the same positioning and duration as the experimental group. The device provides auditory and visual cues identical to the active treatment, but no laser energy is emitted to the tissue. Participants will also use a standard wrist splint.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Laser Therapy (HILT) | Experimental | Patients in this group will receive High-Intensity Laser Therapy (HILT) in addition to using a neutral wrist splint. The treatment will consist of a total of 10 sessions, administered 5 days per week for a duration of 2 weeks. Receives: Device: High-Intensity Laser Therapy (HILT) |
| Sham High-Intensity Laser Therapy | Sham comparator | Patients in this group will receive sham (placebo) laser therapy in addition to using a neutral wrist splint. The treatment will consist of a total of 10 sessions, administered 5 days per week for a duration of 2 weeks. Receives: Device: Sham High-Intensity Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity assessed by Visual Analog Scale (VAS)
Pain intensity will be evaluated using the Visual Analog Scale (VAS). This is a self-reported scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "severe pain". Higher scores indicate a worse outcome (greater pain intensity).
Measured: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Symptom Severity and Functional Status assessed by Boston Carpal Tunnel Questionnaire (BCTQ)
The BCTQ consists of two subscales: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). The SSS has 11 items and the FSS has 8 items. Each item is scored on a scale from 1 to 5, where 1 indicates "no symptoms/no difficulty" and 5 indicates "severe symptoms/cannot perform activity". The final score is calculated as the mean of the items. Higher scores indicate a worse outcome (more severe symptoms and greater functional impairment).
Measured: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Secondary outcomes (9)
Median Nerve Cross-Sectional Area(CSA)
The cross-sectional area of the median nerve will be measured by ultrasonography at the proximal carpal tunnel level. In Carpal Tunnel Syndrome (CTS), the nerve typically swells due to edema and inflammation. A decrease in the cross-sectional area indicates a positive response to treatment.
Unit of Measure: Square millimeters (mm²) Interpretation: Lower values indicate a better clinical outcome (reduction in nerve edema).BE
Measured: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period
Hand Grip Strength
Evaluation of the maximum isometric strength of the hand and forearm muscles using a hydraulic hand dynamometer (Baseline® hydraulic LCD hand dynamometer). The measurement is performed with the patient seated, elbow flexed at 90 degrees and wrist in a neutral position. The average of three measurements is recorded.
Interpretation: Higher scores indicate a better outcome. An increase in grip strength suggests improved muscular function and a reduction in the inhibitory effects of pain and nerve compression caused by Carpal Tunnel Syndrome.
Unit of Measure: Kilograms (kg)
Measured: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Pinch Strength (Lateral Pinch)
Description: Evaluation of the strength of the pinch between the thumb and the index finger using a hydraulic pinch gauge (Baseline® hydraulic LCD pinch gauge). Lateral pinch is measured by asking the patient to press between the pad of the thumb and the lateral aspect of the index finger.
Interpretation: Higher scores indicate a better outcome. Improved pinch strength reflects better coordination and strength of the intrinsic hand muscles innervated by the median nerve.
Unit of Measure: Kilograms (kg)
Measured: Time Frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Median Nerve Motor Distal Latency (MDL)
Evaluation of the motor component of the median nerve using an Electroneuromyography (ENMG) device (Nihon Kohden Neuropack 2).
MDL reflects the time taken for an electrical impulse to travel from the wrist to the thenar muscle.
Unit of Measure: Milliseconds (ms) Interpretation: Lower scores (shorter latency) indicate a better outcome. A decrease in latency suggests improved nerve conduction across the carpal tunnel, reflecting a reduction in nerve compression.
Measured: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Median Nerve Compound Muscle Action Potential (CMAP) Amplitude
Measurement of the motor action potential amplitude, reflecting the integrity of the motor axons and neuromuscular junctions.
Unit of Measure: Millivolts (mV) Interpretation: Higher amplitudes indicate a better outcome. An increase in amplitude suggests better motor axon recruitment and improved neuromuscular function.
Measured: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Median Nerve Sensory Conduction Velocity (Palmar)
Description: Measurement of the sensory conduction speed of the median nerve in the palmar segment (palm-to-wrist). This segment is often more sensitive to early compression within the carpal tunnel.
Interpretation: Higher scores (faster velocity) indicate a better outcome. An increase in velocity indicates improved nerve function in the specific segment where compression is most prominent.
Unit of Measure: Meters per second (m/s)
Measured: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Median Nerve Sensory Conduction Velocity (SCV)(Digit 2)
Description: Evaluation of the sensory conduction speed of the median nerve recorded from the 2nd digit to the wrist. It measures how fast electrical impulses travel through the distal part of the nerve.
Interpretation: Higher scores (faster velocity) indicate a better outcome. An increase in velocity suggests that the sensory fibers of the median nerve are recovering and conducting signals more efficiently.
Unit of Measure: Meters per second (m/s)
Measured: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Median Nerve Sensory Action Potential (SNAP) Amplitude (Palmar)
Description: Peak-to-peak measurement of the electrical response of the median nerve sensory fibers, recorded from the palmar segment to the wrist.
Interpretation: Higher amplitudes indicate a better outcome. An increase in palmar SNAP amplitude indicates a recovery in the number of sensory fibers successfully conducting through the carpal tunnel.
Unit of Measure: Microvolts (µV)
Measured: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Median Nerve Sensory Action Potential (SNAP) Amplitude (Digit 2)
Description: Peak-to-peak measurement of the electrical response of the median nerve sensory fibers, recorded from the 2nd digit.
Interpretation: Higher amplitudes indicate a better outcome. Increased amplitude reflects a greater number of healthy, functioning sensory axons and improved nerve integrity.
Unit of Measure: Microvolts (µV)
Measured: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start2 Nov 2025
- Primary completion5 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: a High-Intensity Laser Therapy (HILT) group or a sham HILT group. Both groups will receive standard wrist splinting as part of conservative management. Outcomes will be assessed and compared between groups at predefined time points.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filiz Eser, professor, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414069
- Sponsor's protocol ID
- 1-24-647
- Status last verified
- Dec 2025
- First submitted
- 14 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yigit F, Ordahan B. Effects of high-intensity laser therapy on pain, functional status, hand grip strength, and median nerve cross-sectional area by ultrasonography in patients with carpal tunnel syndrome. Lasers Med Sci. 2023 Oct 31;38(1):248. doi: 10.1007/s10103-023-03913-z.
PubMed 37906312de la Barra Ortiz HA, Avila MA, Parizotto NA, Liebano RE. A systematic review and meta-analysis of the effectiveness of high-intensity laser therapy in patients with carpal tunnel syndrome. Physiotherapy. 2025 Sep;128:101780. doi: 10.1016/j.physio.2025.101780. Epub 2025 Mar 5.
PubMed 40121869
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical, Sonographic, and Electrophysiological Efficacy of High-Intensity Laser Therapy (HILT) in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07414069
- Acronym / sponsor ID
- 1-24-647
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, High-Intensity Laser Therapy, HILT, Entrapment Neuropathy, Median Nerve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 2 Nov 2025 (actual)
- Primary completion
- 5 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper extremity and is characterized by pain, paresthesia, and functional impairment resulting from increased pressure within the carpal tunnel. Although conservative treatment approaches such as splinting and pharmacological therapy are commonly used, High-Intensity Laser Therapy (HILT) has emerged as a non-invasive modality with potential analgesic, anti-inflammatory, and biostimulatory effects. However, evidence regarding its efficacy remains limited, particularly from sham-controlled studies incorporating objective outcome measures. This prospective, randomized, double-blind, sham-controlled clinical trial aims to evaluate the clinical, sonographic, and electrophysiological effectiveness of HILT in patients with mild-to-moderate CTS. Eligible patients aged 18 to 65 years with electrophysiologically confirmed mild-to-moderate CTS will be randomized into two groups: a HILT group and a sham HILT group. Both groups will receive standard wrist splinting as part of conservative management. Clinical outcomes will be assessed using Visual Analog Scale (VAS) scores for pain, Boston Carpal Tunnel Questionnaire (BCTQ) scores for symptom severity and functional status, and grip strength measurements. Objective evaluations will include median nerve sensory and motor nerve conduction studies and ultrasonographic measurement of the median nerve cross-sectional area at the proximal carpal tunnel level. Assessments will be performed at baseline and at 1 and 3 months after treatment. This study aims to provide robust and objective evidence regarding the therapeutic effectiveness of HILT in the conservative management of carpal tunnel syndrome.
Detailed description
Carpal Tunnel Syndrome (CTS) is the most common entrapment neuropathy of the upper extremity, characterized by the compression of the median nerve due to increased pressure within the carpal tunnel. While conservative management strategies such as splinting and physical therapy modalities are the standard approach, High-Intensity Laser Therapy (HILT) has recently emerged as a potent, non-invasive therapeutic option . Utilizing an Nd:YAG laser source, HILT penetrates deep tissues to induce photochemical and photothermal effects. It is hypothesized to promote tissue repair by increasing ATP synthesis at the mitochondrial level, regulating Na/K pump activity, and providing analgesia by suppressing inflammatory mediators .
Although HILT is used in clinical practice, there is a scarcity of sham-controlled, double-blind studies that comprehensively evaluate its efficacy using a combination of clinical, electrophysiological, and ultrasonographic (median nerve cross-sectional area) parameters .
Study Objective: The primary objective of this prospective, randomized, double-blind, sham-controlled trial is to provide evidence-based data on the efficacy of HILT regarding pain, hand function, grip strength, nerve conduction velocities, and median nerve morphology (ultrasonographic cross-sectional area) in patients with mild-to-moderate CTS.
Study Population and Design: Patients aged 18-65 years presenting to the Physical Therapy Clinic with clinically and electrophysiologically confirmed 80 patient hand mild-to-moderate CTS will be recruited.
Outcome Measures and Timeline: Assessments will be performed by independent blinded researchers at Baseline, Month 1, and Month 3 post-treatment.
- Clinical Assessment: Pain intensity (Visual Analog Scale - VAS), symptom severity and functional status (Boston Carpal Tunnel Questionnaire - BCTQ), gross grip strength (Hand Dynamometer), and pinch strength (Pinchmeter) .
- Ultrasonographic Assessment: Measurement of the median nerve Cross-Sectional Area (CSA) at the proximal carpal tunnel inlet.
- Electrophysiological Assessment: Sensory and motor nerve conduction studies of the median nerve (evaluating distal latency, conduction velocity, and amplitude).
This study aims to demonstrate the multifaceted contribution (clinical, anatomical, and physiological) of HILT to nerve recovery by reducing edema and inflammation in the pathophysiology of CTS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: a High-Intensity Laser Therapy (HILT) group or a sham HILT group. Both groups will receive standard wrist splinting as part of conservative management. Outcomes will be assessed and compared between groups at predefined time points.
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Laser Therapy (HILT) | Experimental | Device: High-Intensity Laser Therapy (HILT)Patients in this group will receive High-Intensity Laser Therapy (HILT) in addition to using a neutral wrist splint. The treatment will consist of a total of 10 sessions, administered 5 days per week for a duration of 2 weeks. |
| Sham High-Intensity Laser Therapy | Sham comparator | Device: Sham High-Intensity Laser TherapyPatients in this group will receive sham (placebo) laser therapy in addition to using a neutral wrist splint. The treatment will consist of a total of 10 sessions, administered 5 days per week for a duration of 2 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- Clinical symptoms consistent with carpal tunnel syndrome
- Electrophysiologically confirmed mild or moderate carpal tunnel syndrome
- Ability to comply with the study protocol and follow-up assessments
- Provided written informed consent
Key exclusion criteria (8 listed)
- Severe carpal tunnel syndrome on electrophysiological examination
- Previous surgical treatment for carpal tunnel syndrome
- Local causes of carpal tunnel syndrome (e.g., mass lesions, ganglion cysts, tumors)
- Systemic conditions associated with carpal tunnel syndrome (e.g., diabetes mellitus, hypothyroidism, pregnancy, acromegaly)
- History of corticosteroid injection for carpal tunnel syndrome within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Laser Therapy (HILT)Procedure: The laser is applied to the carpal tunnel area while the patient's forearm is in supination. Device Specifications: Pulsed Nd:YAG laser source with Peak Power >3000 W, Intensity (max) 15,000 W/cm², Frequency 10-30 Hz, Pulse duration ≤ 100 μs, and a spot size of 0.5 cm diameter (0.2 cm²). Treatment Protocol (3 Phases): 1. Initial Rapid Scan (3 Steps): Step 1: 25 Hz, 510 mJ/cm², 139 J energy. Step 2: 20 Hz, 610 mJ/cm², 139 J energy. Step 3: 19 Hz, 710 mJ/cm², 139 J energy. 2. Trigger Point Phase: Applied to painful points on the affected side. Step 1: 15 Hz, 360 mJ/cm², 6.3 J energy. Step 2: 15 Hz, 510 mJ/cm², 9 J energy. Step 3: 14 Hz, 610 mJ/cm², 10.1 J energy (applied for 6 seconds per point). 3. Final Slow Scan: Performed using the same parameters as the rapid scan phase. Total Energy: A total of 835 Joules is delivered per session. | Device | High-Intensity Laser Therapy (HILT) |
| Sham High-Intensity Laser TherapyThe same HIRO TT device is used with the same positioning and duration as the experimental group. The device provides auditory and visual cues identical to the active treatment, but no laser energy is emitted to the tissue. Participants will also use a standard wrist splint. | Device | Sham High-Intensity Laser Therapy |
Primary outcome
Pain Severity assessed by Visual Analog Scale (VAS)
Time frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Pain intensity will be evaluated using the Visual Analog Scale (VAS). This is a self-reported scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "severe pain". Higher scores indicate a worse outcome (greater pain intensity).
Symptom Severity and Functional Status assessed by Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
The BCTQ consists of two subscales: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). The SSS has 11 items and the FSS has 8 items. Each item is scored on a scale from 1 to 5, where 1 indicates "no symptoms/no difficulty" and 5 indicates "severe symptoms/cannot perform activity". The final score is calculated as the mean of the items. Higher scores indicate a worse outcome (more severe symptoms and greater functional impairment).
9 secondary outcomes
Median Nerve Cross-Sectional Area(CSA)
Time frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period
Hand Grip Strength
Time frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Pinch Strength (Lateral Pinch)
Time frame: Time Frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Median Nerve Motor Distal Latency (MDL)
Time frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Median Nerve Compound Muscle Action Potential (CMAP) Amplitude
Time frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Median Nerve Sensory Conduction Velocity (Palmar)
Time frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Median Nerve Sensory Conduction Velocity (SCV)(Digit 2)
Time frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Median Nerve Sensory Action Potential (SNAP) Amplitude (Palmar)
Time frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Median Nerve Sensory Action Potential (SNAP) Amplitude (Digit 2)
Time frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 37906312Yigit F, Ordahan B. Effects of high-intensity laser therapy on pain, functional status, hand grip strength, and median nerve cross-sectional area by ultrasonography in patients with carpal tunnel syndrome. Lasers Med Sci. 2023 Oct 31;38(1):248. doi: 10.1007/s10103-023-03913-z.
- Background: PubMed 40121869de la Barra Ortiz HA, Avila MA, Parizotto NA, Liebano RE. A systematic review and meta-analysis of the effectiveness of high-intensity laser therapy in patients with carpal tunnel syndrome. Physiotherapy. 2025 Sep;128:101780. doi: 10.1016/j.physio.2025.101780. Epub 2025 Mar 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Filiz Eser, professor principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Laser Therapy (HILT) in people with Carpal Tunnel Syndrome, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ceren FINDIK KILIÇ (+905312689928, crn.fndk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity assessed by Visual Analog Scale (VAS) (time frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07414069, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.