ClinicalTrials.gg
Not yet recruitingNCT07788248Updated Aug 26, 2026

Low-Level Laser Therapy for Carpal Tunnel Syndrome

An interventional study of Low-Level Laser Therapy (LLLT) and Paraffin Bath Therapy in Carpal Tunnel Syndrome (CTS), sponsored by Bursa Yuksek Ihtisas Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Bursa Yuksek Ihtisas Training and Research Hospital · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 128 studies in Carpal Tunnel Syndrome with a site in Turkey — 35 open to participants now, 39 under way, none of them phase 3. Carpal Tunnel Syndrome · Turkey.

Planned enrollment
6th of 81
105 · median 60
Started
2026
with 17 others
No phase
74 of 128
20 open now
Primary completion
2027-02
later than 32 of 38 live
Registered
123rd of 128
by date

Among the 128 studies in Carpal Tunnel Syndrome with a site in Turkey, this one is the 6th largest by planned enrollment of the 81 interventional ones that give a count, is one of 18 that started in 2026, is one of 74 with no phase, reaches primary completion later than 32 of the 38 other live ones, and was the 123rd registered.

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.

Browse Carpal Tunnel Syndrome studies →

Open to participants now

35 of the 128 studies in Carpal Tunnel Syndrome with a site in Turkey are open now. Recruiting first, the newest first:

30 more — sign in →

All 35 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 73 Carpal Tunnel Syndrome studies recruiting now, 27 (37%) set no upper age limit and 37 (51%) stop at 75 or younger; 1 takes children under 18; 10 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 128 studies in Carpal Tunnel Syndrome with a site in Turkey, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Carpal Tunnel Syndrome (CTS)

Keywords

  • Low-level laser therapy
  • Carpal tunnel syndrome
  • Paraffin bath therapy
  • median nerve ultrasonography
  • median nerve conduction study
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study

Exclusion criteria

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 ( 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 under treatment
  • Pregnancy
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
105 participants (estimated)

Study arms

  • Experimental
    Experimental: LLLT Group

    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
    Active Comparator: Paraffin Group

    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 Comparator: Sham LLLT Group

    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

  • DeviceLow-Level Laser Therapy (LLLT)

    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

  • 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)

    Also known as: Zirvemed paraffin device

  • DeviceSham Low-Level Laser Therapy

    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

  • OtherStandard Conservative Care

    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)

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

Secondary outcomes

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

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

    Time frame: Before treatment and 3 months after treatment completion

  2. Change from Baseline in Median Sensory Nerve Conduction Velocity

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

    Time frame: Before treatment and 3 months after treatment completion

  3. Change from Baseline in Median Sensory Distal Latency

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

    Time frame: Before treatment and 3 months after treatment completion

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

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

    Time frame: Before treatment and 3 months after treatment completion

  5. Change from Baseline in Median Motor Nerve Conduction Velocity

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

    Time frame: Before treatment and 3 months after treatment completion

  6. Change from Baseline in Median Motor Distal Latency

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

    Time frame: Before treatment and 3 months after treatment completion

  7. 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)

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

  8. 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)

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

  9. 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)

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

  10. 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)

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

  11. 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)

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.

Of 251 non-industry interventional studies with no phase under Carpal Tunnel Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 5 months is below that.

Counting every sponsor, half of 261 studies reached it within 12 months; a quarter within 7 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2026
First posted
Aug 26, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Feb 1, 2027
CompletionEst.
Feb 1, 2027
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07788248
Lead sponsor
Bursa Yuksek Ihtisas Training and Research Hospital
Responsible party
Sinem Akselim (Principle investigator, Bursa Yuksek Ihtisas Training and Research Hospital) — Principal investigator
First posted
Aug 26, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Aug 26, 2026

Study contacts

Sinem Akselim
Contact
sinemakselim@gmail.com
+905336391332

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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