Carpal Tunnel Syndrome (CTS)NCT07788248
Low-Level Laser Therapy for Carpal Tunnel Syndrome
A study testing Low-Level Laser Therapy (LLLT), Paraffin Bath Therapy and Standard Conservative Care in people with Carpal Tunnel Syndrome (CTS), run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Low-Level Laser Therapy (LLLT), Paraffin Bath Therapy and Standard Conservative Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Feb 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Injection therapy for CTS within the past 3 months
- Prior CTS surgery with recurrence
- Active malignancy under treatment
- Pregnancy
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
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Bursa
Sinem Akselim, +905336391332, sinemakselim@gmail.com
About this study
Official 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
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.
Read more
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)
- Being tested
- Low-Level Laser Therapy (LLLT), Paraffin Bath Therapy, Sham Low-Level Laser Therapy, Standard Conservative Care
- Keywords
- Low-level laser therapy, Carpal tunnel syndrome, Paraffin bath therapy, median nerve ultrasonography, median nerve conduction study
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser Therapy (LLLT)Device
Also called BTL 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)
Paraffin Bath TherapyDevice
Also called Zirvemed paraffin 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)
Sham Low-Level Laser TherapyDevice
Also called Sham BTL LLLT 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)
Standard Conservative CareOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Device: Sham Low-Level Laser Therapy; Other: Standard Conservative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Assessed via median sensory nerve conduction study. Unit of Measure: microvolts (µV)
Measured: Before treatment and 3 months after treatment completion
Change from Baseline in Median Sensory Nerve Conduction Velocity
Assessed via median sensory nerve conduction study. Unit of Measure: meters/second (m/s)
Measured: Before treatment and 3 months after treatment completion
Change from Baseline in Median Sensory Distal Latency
Assessed via median sensory nerve conduction study. Unit of Measure: milliseconds (ms)
Measured: Before treatment and 3 months after treatment completion
Change from Baseline in Median Motor Compound Muscle Action Potential Amplitude
Assessed via median motor nerve conduction study. Unit of Measure: millivolts (mV)
Measured: Before treatment and 3 months after treatment completion
Change from Baseline in Median Motor Nerve Conduction Velocity
Assessed via median motor nerve conduction study. Unit of Measure: meters/second (m/s)
Measured: Before treatment and 3 months after treatment completion
Change from Baseline in Median Motor Distal Latency
Assessed via median motor nerve conduction study. Unit of Measure: milliseconds (ms)
Measured: Before treatment and 3 months after treatment completion
Change from Baseline in Median Nerve Cross-Sectional Area (Ultrasonography)
Median nerve cross-sectional area, transverse diameters, intraneural vascularity, echogenicity, and palmar bowing will be assessed by ultrasonography.
Unit of Measure: square millimeters (mm²)
Measured: Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion
Change from Baseline in Grip Strength
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)
Measured: Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion
Change from Baseline in Pinch Strength (Tip, Tripod, and Tip-to-Tip Pinch)
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)
Measured: Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion
Change from Baseline in Pain (Visual Analog Scale)
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)
Measured: Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion
Change from Baseline in QuickDASH Score
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)
Measured: Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sinem Akselim, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788248
- Sponsor's protocol ID
- 2024-KAEK-13 2026-10/11
- Status last verified
- Jul 2026
- First submitted
- 22 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07788248
- Acronym / sponsor ID
- 2024-KAEK-13 2026-10/11
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Low-level laser therapy, Carpal tunnel syndrome, Paraffin bath therapy, median nerve ultrasonography, median nerve conduction study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 26 Aug 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: LLLT Group | Experimental | Device: Low-Level Laser Therapy (LLLT), Other: Standard Conservative CareParticipants in this arm will receive active low-level laser therapy in addition to standard conservative care (night wrist splinting and home exercise program). |
| Active Comparator: Paraffin Group | Active comparator | Device: Paraffin Bath Therapy, Other: Standard Conservative CareParticipants in this arm will receive paraffin bath therapy in addition to standard conservative care (night wrist splinting and home exercise program). |
| Sham Comparator: Sham LLLT Group | Sham comparator | Device: Sham Low-Level Laser Therapy, Other: Standard Conservative CareParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| Low-Level Laser Therapy (LLLT)Also: BTL 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) | Device | Experimental: LLLT Group |
| Paraffin Bath TherapyAlso: Zirvemed paraffin 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) | Device | Active Comparator: Paraffin Group |
| Sham Low-Level Laser TherapyAlso: Sham BTL LLLT 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) | Device | Sham Comparator: Sham LLLT Group |
| Standard Conservative CareAll 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) | Other | Active Comparator: Paraffin Group, Experimental: LLLT Group, Sham Comparator: Sham LLLT Group |
Primary outcome
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
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
11 secondary outcomes
Change from Baseline in Median Sensory Nerve Action Potential Amplitude
Time frame: Before treatment and 3 months after treatment completion
Change from Baseline in Median Sensory Nerve Conduction Velocity
Time frame: Before treatment and 3 months after treatment completion
Change from Baseline in Median Sensory Distal Latency
Time frame: Before treatment and 3 months after treatment completion
Change from Baseline in Median Motor Compound Muscle Action Potential Amplitude
Time frame: Before treatment and 3 months after treatment completion
Change from Baseline in Median Motor Nerve Conduction Velocity
Time frame: Before treatment and 3 months after treatment completion
Change from Baseline in Median Motor Distal Latency
Time frame: Before treatment and 3 months after treatment completion
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
Change from Baseline in Grip Strength
Time frame: Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion
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
Change from Baseline in Pain (Visual Analog Scale)
Time frame: Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion
Change from Baseline in QuickDASH Score
Time frame: Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion
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 26 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy (LLLT), Paraffin Bath Therapy and Standard Conservative Care in people with Carpal Tunnel Syndrome (CTS), run by Bursa Yuksek Ihtisas Training and Research Hospital 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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 26 Aug 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 Sinem Akselim (+905336391332, sinemakselim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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?
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 26 Aug 2026.