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

7. juli 2026 opdateret af: Mahidol University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

144

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

patient suspected CTS

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Carpal tunnel syndrome
patient with suspected CTS

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic value
Tidsramme: at the Enrollment
Diagnostic value of Digital Infrared Thermographic in diagnosis of CTS
at the Enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

30. november 2027

Studieafslutning (Anslået)

30. november 2027

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Karpaltunnelsyndrom (CTS)

3
Abonner