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Carpal Tunnel Syndrome (CTS)NCT07699289

Diagnostic Value of Digital Infrared Thermographic Imaging in Diagnosing Carpal Tunnel Syndrome

An observational study of Carpal Tunnel Syndrome (CTS), run by Mahidol University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to evaluate skin temperature patterns measured by infrared thermography in patients with carpal tunnel syndrome (CTS). The main questions it aims to answer are: Are skin temperature patterns associated with CTS as determined by 6-item CTS scale? Participants diagnosed with CTS… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Carpal Tunnel Syndrome (CTS)
How many people
144 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 30 Nov 2027
How long will I take part?
1 Day
Phase
Observational
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: patient suspected CTS

Who may be able to join

  • 18 years old or more
  • Were referred to the department of rehabilitation for electrodiagnostic evaluation of the disease not involved in the index hand
  • The hand of interest has cumulative score of less than 12 from CTS-6 scale

Who cannot join

  • History of hand surgery in the index hand
  • Having a condition which may alter surface temperature of the hand, for example, infection, scar in the interested area, arthritis, other peripheral neuropathy, uncontrolled diabetes mellitus, uncontrolled thyroid disease, stroke, and vascular disease
  • Having hand deformities that render collecting DITI information to calculate the parameters of interest impossible, for example, amputation of any part of the hand
  • Current medication affecting sympathetic tone
  • Severe tremors or inability to maintain standardized positioning
  • Electrodiagnosis result other than normal or carpal tunnel syndrome in the hand of interest

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Apisara Keesukphan contact

6622011154

apisara.kee@mahidol.ac.th

About this study

The goal of this observational study is to evaluate skin temperature patterns measured by infrared thermography in patients with carpal tunnel syndrome (CTS). The main questions it aims to answer are: Are skin temperature patterns associated with CTS as determined by 6-item CTS scale?

Participants diagnosed with CTS as part of their routine clinical care will undergo infrared thermal imaging and electrodiagnostic evaluation according to the study protocol. The relationship between thermographic findings and electrodiagnostic severity will be analyzed.

Read the detailed description

Methods

Submit the study protocol for approval by the Human Research Ethics Committee of Ramathibodi Hospital.

Recruit eligible participants, including both cases and controls, who meet the predefined inclusion and exclusion criteria.

Explain the study objectives and procedures to all potential participants. Written informed consent will be obtained from all participants before enrollment.

Digital infrared thermography of both hands will be performed according to the following standardized procedure:

  1. Participants will be asked whether they have received any physical therapy or physical modality to the index hand within the preceding 24 hours. If so, the thermographic examination will be rescheduled for the next visit whenever possible; otherwise, the participant may be excluded.
  2. Participants will be asked whether they have applied any oil, cream, powder, deodorant, or antiperspirant to their hands. If present, these substances will be removed by washing before image acquisition.
  3. Participants will remain in the examination room with both hands dry, uncovered, and resting at room temperature for at least 15 minutes to allow thermal equilibration.
  4. Infrared thermographic images of the index hand will be obtained with the hand positioned perpendicular to the detector at a fixed distance sufficient to include all fingers and the wrist within the image.
  5. For participants undergoing electrodiagnostic evaluation as part of routine clinical care, thermography will be performed before the electrodiagnostic study.

A physician will perform history taking, physical examination, and assessment using the CTS-6 scale. The following information will be collected:

  1. Age
  2. Sex
  3. Comorbidities
  4. Duration of symptoms (months)
  5. Side of the affected hand
  6. CTS-6 score (<12 or ≥12)
  7. Autonomic symptoms, including edema, dry skin, skin pallor, sweating asymmetry, skin temperature asymmetry, and Raynaud's phenomenon
  8. Small-fiber sensory assessment, including pinprick sensation and cold sensation screening using a cold metal instrument

Skin temperature will be measured from thermographic images at the first, second, and third fingertips, the thenar eminence, and the hypothenar eminence. Thermographic parameters will subsequently be calculated according to the method described by Park et al.

Electrodiagnostic findings of the index hand will be retrieved from medical records if the examination was performed as part of routine clinical care. The following information will be collected:

  1. Final electrodiagnostic interpretation (normal, carpal tunnel syndrome, or other neuropathies)
  2. Key electrodiagnostic findings supporting the interpretation (e.g., median distal sensory peak latency and median distal motor latency)

Electrodiagnostic findings will not be used to determine participant eligibility or establish the diagnosis. Diagnostic accuracy analyses will be performed using the CTS-6 as the primary reference standard.

Statistical analyses will be performed to determine the diagnostic performance of infrared thermography.

Study findings will be analyzed and reported.

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.

Study groups in NCT07699289
Study groupRoleWhat they receive
Carpal tunnel syndromepatient with suspected CTS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic value

    Diagnostic value of Digital Infrared Thermographic in diagnosis of CTS

    Measured: at the Enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
144 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07699289
Sponsor's protocol ID
MURA2026/366
Status last verified
Jul 2026
First submitted
7 Jul 2026
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park D, Kim BH, Lee SE, Kim DY, Eom YS, Cho JM, Yang JW, Kim M, Kwon HD, Lee JW. Application of digital infrared thermography for carpal tunnel syndrome evaluation. Sci Rep. 2021 Nov 9;11(1):21963. doi: 10.1038/s41598-021-01381-5.

    PubMed 34754001

Questions about this trial

What is this clinical trial studying?

An observational study of Carpal Tunnel Syndrome (CTS), run by Mahidol University.

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 3 inclusion and 6 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 Apisara Keesukphan (6622011154, apisara.kee@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic value (time frame: at the Enrollment). 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 NCT07699289, which also lists 1 linked publication.

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 13 Jul 2026.

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