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Clinical Trials/NCT07605585
NCT07605585Active, not recruitingNot Applicable

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

Karolinska Institutet1 site in 1 country10 target enrollmentStarted: December 4, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
10
Locations
1

Study Overview

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Neurologic disease
  • 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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cecilia Mellstrand Navarro

ass prof

Karolinska Institutet

Study Sites (1)

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