NCT07605585

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
Last Updated

May 26, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 2, 2026

Last Update Submit

May 18, 2026

Conditions

Reliability of Sensory Neurography and S2PD

Keywords

S2PDDigital nerve injurySensory neurographySensory nerve action potentials

Outcome Measures

Primary Outcomes (1)

  • Reliability of method: Sensory neurography measurements (AREA) performed on two separate occasions.

    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.

Secondary Outcomes (3)

  • Assessment of agreement AREA

    Measurements will be performed at baseline and at 2 weeks.

  • Reliability of method: Sensory neurography measurements (SNAP) performed on two separate occasions

    Measures will be assessed at baseline and 2 weeks.

  • Assessment of agreement SNAP

    Measurements at baseline and 2 weeks

Study Arms (2)

S2PD and sensory neurography

ACTIVE COMPARATOR

Radial digital nerve of second and fourth finger on both hands, are first examined with S2PD, secondly with Sensory neurography.

Diagnostic Test: S2PDDiagnostic Test: Sensory neurography

Sensory neurography and S2PD

ACTIVE COMPARATOR

Radial digital nerve of second and fourth finger on both hands, are first examined with Sensory neurography, secondly with S2PD

Diagnostic Test: S2PDDiagnostic Test: Sensory neurography

Interventions

S2PDDIAGNOSTIC_TEST

see section "study description"

S2PD and sensory neurographySensory neurography and S2PD
Sensory neurographyDIAGNOSTIC_TEST

see section "study description"

S2PD and sensory neurographySensory neurography and S2PD

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age \>20
  • Age \<60

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hand Surgery, Södersjukhuset Hospital, Stockholm, Sweden

Stockholm, Sweden

Location

Related Publications (4)

  • Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

    PMID: 2868172BACKGROUND

  • Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204.

    PMID: 10501650BACKGROUND

  • Bland JM, Altman DG. Comparing methods of measurement: why plotting difference against standard method is misleading. Lancet. 1995 Oct 21;346(8982):1085-7. doi: 10.1016/s0140-6736(95)91748-9.

    PMID: 7564793BACKGROUND

  • Pan D, Patel AU, Patterson JM, Johnson AR, Gordon T, Mackinnon SE. Surgeons, physiatrists and neurologists speaking "EDX and nerve surgery": A paradigm shift for nerve injured patients. JPRAS Open. 2025 Nov 12;47:3-20. doi: 10.1016/j.jpra.2025.11.004. eCollection 2025.

    PMID: 41497893BACKGROUND

Study Officials

  • Cecilia Mellstrand Navarrro, Associate professor

    Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Model Details: Test-Retest, reliability study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ass prof

Study Record Dates

First Submitted

February 2, 2026

First Posted

May 26, 2026

Study Start

December 4, 2025

Primary Completion

January 20, 2026

Study Completion

May 1, 2026

Last Updated

May 26, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

All data will be shared, in pseudonymised form.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Supporting information will be available upon study completion and retained for ten years.
Access Criteria
All data will be available from corresponding author upon reasonable request.

Locations

SE(1)