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Sensory Neurography and S2PD, a Test-Retest Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07605585
Enrollment
10
Registered
2026-05-26
Start date
2025-12-04
Completion date
2026-05-01
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reliability of Sensory Neurography and S2PD

Keywords

S2PD, Digital nerve injury, Sensory neurography, Sensory nerve action potentials

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. 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.

Interventions

DIAGNOSTIC_TESTS2PD

see section "study description"

DIAGNOSTIC_TESTSensory neurography

see section "study description"

Sponsors

Karolinska Institutet
Lead SponsorOTHER
Stockholm South General Hospital
CollaboratorOTHER
AFA Insurance
CollaboratorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention model description

Test-Retest, reliability study.

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Assessment of agreement AREAMeasurements 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%.
Reliability of method: Sensory neurography measurements (SNAP) performed on two separate occasionsMeasures 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.
Assessment of agreement SNAPMeasurements at baseline and 2 weeksThe 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%.

Countries

Sweden

Contacts

PRINCIPAL_INVESTIGATORCecilia Mellstrand Navarrro, Associate professor

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026