Reliability of Sensory Neurography and S2PDNCT07605585
Sensory Neurography and S2PD, a Test-Retest Study
A study testing S2PD and Sensory neurography in people with Reliability of Sensory Neurography and S2PD, run by Karolinska Institutet at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Reliability of Sensory Neurography and S2PD
- What is being tested?
- S2PD and Sensory neurography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 4 Dec 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >20
- Age <60
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site
Department of Hand Surgery, Södersjukhuset Hospital, Stockholm, Sweden
Stockholm
About this study
Official title: 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.
Read the 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.
- Being tested
- S2PD, Sensory neurography
- Keywords
- S2PD, Digital nerve injury, Sensory neurography, Sensory nerve action potentials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S2PDDiagnostic test
see section "study description"
Sensory neurographyDiagnostic test
see section "study description"
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: S2PD; Diagnostic 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 Receives: Diagnostic Test: S2PD; Diagnostic Test: Sensory neurography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Measures will be assessed at baseline and 2 weeks.
Secondary outcomes (3)
Assessment of agreement AREA
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%.
Measured: Measurements will be performed at baseline and at 2 weeks.
Reliability of method: Sensory neurography measurements (SNAP) performed on two separate occasions
ICC (Intraclass correlation coefficient) will be used to assess whether the measurement method demonstrates sufficient correlation to be considered reliable.
Measured: Measures will be assessed at baseline and 2 weeks.
Assessment of agreement SNAP
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%.
Measured: Measurements at baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start4 Dec 2025
- Primary completion20 Jan 2026
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Reliability of Sensory Neurography and S2PDStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Test-Retest, reliability study.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital, AFA Insurance
- Responsible party
- Principal investigator, Cecilia Mellstrand Navarro, Karolinska Institutet
- Investigators
- Cecilia Mellstrand Navarrro, Associate professor, Principal investigator, Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605585
- Sponsor's protocol ID
- 2024-08365-02
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared, in pseudonymised form.
Publications
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
PubMed 2868172Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204.
PubMed 10501650Bland 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.
PubMed 7564793Pan 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.
PubMed 41497893
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Neurography and S2PD: A Test-Retest Study in Ten Healthy Individuals to Assess Method Reliability
- ClinicalTrials.gov ID
- NCT07605585
- Acronym / sponsor ID
- 2024-08365-02
- Keywords
- S2PD, Digital nerve injury, Sensory neurography, Sensory nerve action potentials
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital, AFA Insurance
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Test-Retest, reliability study.
| Arm | Type | Receives |
|---|---|---|
| S2PD and sensory neurography | Active comparator | Diagnostic Test: S2PD, Diagnostic Test: Sensory neurographyRadial digital nerve of second and fourth finger on both hands, are first examined with S2PD, secondly with Sensory neurography. |
| Sensory neurography and S2PD | Active comparator | Diagnostic Test: S2PD, Diagnostic Test: Sensory neurographyRadial digital nerve of second and fourth finger on both hands, are first examined with Sensory neurography, secondly with S2PD |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age >20
- Age <60
Key exclusion criteria (8 listed)
- Neurologic disease
- Dementia
- Cognitive disability
- Severe psychiatric disorder (not be able to participate)
- Ongoing drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S2PDsee section "study description" | Diagnostic test | S2PD and sensory neurography, Sensory neurography and S2PD |
| Sensory neurographysee section "study description" | Diagnostic test | S2PD and sensory neurography, Sensory neurography and S2PD |
Primary outcome
Reliability of method: Sensory neurography measurements (AREA) performed on two separate occasions.
Time frame: 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
3 secondary outcomes
Assessment of agreement AREA
Time frame: Measurements will be performed at baseline and at 2 weeks.
Reliability of method: Sensory neurography measurements (SNAP) performed on two separate occasions
Time frame: Measures will be assessed at baseline and 2 weeks.
Assessment of agreement SNAP
Time frame: Measurements at baseline and 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 2868172Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- Background: PubMed 10501650Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204.
- Background: PubMed 7564793Bland 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.
- Background: PubMed 41497893Pan 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.
- Individual participant dataSharing planned: Yes. All data will be shared, in pseudonymised form.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia Mellstrand Navarrro, Associate professor principal investigator
Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S2PD and Sensory neurography in people with Reliability of Sensory Neurography and S2PD, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of method: Sensory neurography measurements (AREA) performed on two separate occasions. (time frame: Measures will be assessed at baseline and 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07605585, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.