Sensory Neurography and S2PD, a Test-Retest Study

Karolinska Institute

Status: Active, not recruiting

Conditions: Reliability of Sensory Neurography and S2PD

Treatments: Diagnostic Test: Sensory neurography; Diagnostic Test: S2PD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07605585

2024-08365-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

S2PD and sensory neurography

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: S2PD

Diagnostic Test: Sensory neurography

Sensory neurography and S2PD

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: S2PD

Diagnostic Test: Sensory neurography