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Sensory Neurography and S2PD, a Test-Retest Study

18. mai 2026 oppdatert av: Cecilia Mellstrand Navarro, Karolinska Institutet

Sensory Neurography and S2PD: A Test-Retest Study in Ten Healthy Individuals to Assess Method Reliability

This study was conducted as a test-retest investigation to assess the reliability of the methods prior to a planned study on the same topic. Ten volunteer participants were recruited from among employees at Sodersjukhuset (South General Hospital). The radial aspects of the second and fourth digits on both hands were examined using static two-point discrimination (S2PD) and sensory neurography on two separate occasions. The results from the two separate measurements will be analysed with an Intra Class Coefficient analysis and a Bland-Altman test.

Studieoversikt

Detaljert beskrivelse

A neurophysiological examination can objectively measure remaining function in an injured digital nerve. Using this method, axons that are still able to conduct an action potential are assessed.

The response can be measured as the amplitude (the summed action potentials from the nerve's axons) and as the area (the amount of functioning axons). The area is a somewhat more precise measurement method, as it includes all axons, both those with low and high conduction velocities. Amplitude measurements may give falsely low values if nerves with poorer degrees of myelination are included in the measurement. Amplitude is measured in µV (microvolt) and area in µV/ms (microvolt per millisecond).

The method currently used to assess discriminative sensation is the S2PD-test. In this test two pins are pressed perpendicular and longitudinally on each side of the fingertip. The pins can consist of an unfolded paper clip or a factory-made discriminator. The distance between the two pins, where it is possible to discriminate between one or two pins, is the S2PD. The test is influenced by many external factors, such as the clinician's level of experience, the patient's desire to give the correct answer, language barriers, and similar issues. Furthermore, this examination method does not clarify what is actually being measured beyond the patient's subjective discriminative sensation.

If neurophysiological assessment is used as a complement to S2PD and can provide an objective measurement tool with high reliability and reproducibility, it could become an important addition to the clinical arsenal for follow-up after nerve injury. Such knowledge would make it easier to clinically evaluate, understand, and monitor the healing process of the injured nerve. It would also facilitate the assessment and systematic follow-up of treatment outcomes.

The participants will be examined at the Hand Surgery Clinic at South General Hospital at two separate occasions separated. Each visit is estimated to last approximately 60 minutes. It will include assessment using S2PD and neurophysiological examination of the radial side of the second and fourth fingers on both hands.

Finger temperature will be measured using an infrared thermometer (Testo 826-T2), and, if necessary, the fingers will be warmed (using a water bath, heating pad or something similar) to a target temperature of a minimum of 32 °C. The hands will then be gently abraded using a preparation gel (NuPrep). Conductive gel (Ten20) will be applied to the electrodes.

A recording electrode will be placed volarly over the wrist, a ground electrode in the palm, and the stimulating electrode on the radial side of the finger (digits II and IV). Electrical stimulation will be delivered in an orthodromic direction, from the finger toward the wrist. The stimulus intensity will be gradually increased until no further increase in amplitude is observed/amplitude is stable. At the first visit, the examination begins with S2PD followed by sensory neurography. At the second visit, the order of the assessments is reversed to minimize potential crossover effects.

Studietype

Intervensjonell

Registrering (Faktiske)

10

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Stockholm, Sverige
        • Department of Hand Surgery, Södersjukhuset Hospital, Stockholm, Sweden

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Age >20
  • Age <60

Exclusion Criteria:

  • Neurologic disease
  • Dementia
  • Cognitive disability
  • Severe psychiatric disorder (not be able to participate)
  • Ongoing drug abuse
  • Not understanding swedish language
  • History of carpal tunnel syndrome
  • Negative experience of electric stimulation

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Enhetens gjennomførbarhet
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: S2PD and sensory neurography
Radial digital nerve of second and fourth finger on both hands, are first examined with S2PD, secondly with Sensory neurography.
see section "study description"
see section "study description"
Aktiv komparator: Sensory neurography and S2PD
Radial digital nerve of second and fourth finger on both hands, are first examined with Sensory neurography, secondly with S2PD
see section "study description"
see section "study description"

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Reliability of method: Sensory neurography measurements (AREA) performed on two separate occasions.
Tidsramme: Measures will be assessed at baseline and 2 weeks.
ICC (Intraclass correlation coefficient) will be used to assess correlation between measurements at baseline and 2 weeks
Measures will be assessed at baseline and 2 weeks.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assessment of agreement AREA
Tidsramme: Measurements will be performed at baseline and at 2 weeks.
The Bland-Altman method will be used to assess whether the measurement method demonstrates sufficient agreement to be considered reliable. The predefined limit for acceptable differences between measurements is 50%.
Measurements will be performed at baseline and at 2 weeks.
Reliability of method: Sensory neurography measurements (SNAP) performed on two separate occasions
Tidsramme: Measures will be assessed at baseline and 2 weeks.
ICC (Intraclass correlation coefficient) will be used to assess whether the measurement method demonstrates sufficient correlation to be considered reliable.
Measures will be assessed at baseline and 2 weeks.
Assessment of agreement SNAP
Tidsramme: Measurements at baseline and 2 weeks
The Bland-Altman method will be used to assess whether the measurement method demonstrates sufficient agreement to be considered reliable. The predefined limit for acceptable differences between measurements is 50%.
Measurements at baseline and 2 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Cecilia Mellstrand Navarrro, Associate professor, Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. desember 2025

Primær fullføring (Faktiske)

20. januar 2026

Studiet fullført (Antatt)

1. mai 2026

Datoer for studieregistrering

Først innsendt

2. februar 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

26. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mai 2026

Sist bekreftet

1. februar 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2024-08365-02

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

All data will be shared, in pseudonymised form.

IPD-delingstidsramme

Supporting information will be available upon study completion and retained for ten years.

Tilgangskriterier for IPD-deling

All data will be available from corresponding author upon reasonable request.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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