Neuropathy;PeripheralNCT03037684
Depolarising Electrical Skin Stimulation in Neuropathic and Postoperative Pain
An observational study of Neuropathy;Peripheral, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The aim of the study is to evaluate voltage gated sodium channel (NaV1.7) dependent pain phenomena in neuropathic pain and chronic postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathy;Peripheral
- What is being tested?
- neurophysiology
- How many people
- 65 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Mar 2017to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with neuropathic pain or with chronic postoperative pain
Who may be able to join
- Group (1) patients with neuropathic pain
- Group (2) patients with chronic postoperative pain
Who cannot join
- severe psychiatric disorder requiring hospitalisation in the past
- any neurological disease other than the pain diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Activation of Unmyelinated Skin Nerve Fibres Using Slow Depolarising Transcutaneous Electrical Stimulation in Patients With Neuropathic Pain or Chronic Postoperative Pain
The aim of the study is to evaluate voltage gated sodium channel (NaV1.7) dependent pain phenomena in neuropathic pain and chronic postoperative pain.
Read the detailed description
Sinus-like electrical stimulation may depolarize unmyelinated skin nociceptors involving NaV1.7 channels. In this case electrical stimulation may provoke pain already with very low currency intensity which normally not provoke pain in healthy subjects. This may be predictive for pain relief due to the sodium channel blocker lidocaine 5% patch.
The study will characterize pain states in peripheral neuropathic pain as well as within the painful scar in chronic postoperative pain with regard to the involvement of NaV1.7 channels.
In addition, the pain site in chronic postoperative pain (scar) will be characterized by laser-evoked potentials (LEP) and quantitative sensory testing (QST).
Pain related questionnaires will be obtained.
- Conditions
- Neuropathy;Peripheral
- Being tested
- neurophysiology
- Keywords
- neuropathic pain, chronic postoperative pain
- Medical subject headings
- Neuritis, Neuralgia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurophysiologyDiagnostic test
electrophysiologic measurements of peripheral nerves
| Study group | Role | What they receive |
|---|---|---|
| chronic pain | individuals suffering from chronic pain Receives: Diagnostic Test: neurophysiology | |
| neuropathic pain | individuals suffering from neuropathic pain Receives: Diagnostic Test: neurophysiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain intensity
numeric rating scale (NRS), rating from 0-10, 0=no pain, 10=maximum pain imaginable
Measured: at baseline and during electric nerve stimulation
Secondary outcomes (16)
heat pain threshold
Ramped stimuli (+1 degree Celsius / sec) that are terminated when the subject presses a button.
Measured: baseline
cold pain threshold
Ramped stimuli (-1 degree Celsius / sec) that are terminated when the subject presses a button.
Measured: baseline
mechanical detection threshold
Fine plastic hairs with different bending forces are applied to the skin to determine the mechanical detection threshold.
Measured: baseline
mechanical pain threshold
Differently weighted pinprick stimuli are applied at a rate of 2sec on and 2sec off in an ascending order until the first percept of sharpness is reached.
Measured: baseline
mechanical pain sensitivity
Differently weighted pinprick stimuli are applied to obtain a stimulus- response function for pinprick-evoked pain. Subjects were asked to give a pain rating for each stimulus (rating from 0-10, 0=no pain, 10=maximum pain)
Measured: baseline
dynamic mechanical allodynia
Different stimuli, tactile and pinprick are applied with the subject giving numerical pain ratings for each stimulus (rating from 0-10, 0=no pain, maximum pain).
Measured: baseline
vibration detection threshold
Tuning fork is placed over a bony prominence until the subject cannot not feel vibration any more.
Measured: baseline
pressure pain threshold
A pressure gauge that exerts forces of ascending stimulus intensities is applied as a slowly increasing ramp over a muscle.
Measured: baseline
LEP latency
latency of N2 and P2 components of laser evoked potential signal curve
Measured: baseline
LEP amplitude
amplitude of laser evoked potential signal curve
Measured: baseline
stadium of pain chronification
assessment of the stadium of pain chronification (stadium 1-3) using standardized questionnaire
Measured: baseline
pain severity
assessment of pain severity (grade 1-4) using the Chronic Pain Grading Questionnaire
Measured: baseline
physical health status
assessing the physical health status using the Short Form-12 questionnaire
Measured: baseline
mental health status
assessing the mental health status using the Short Form-12 questionnaire
Measured: baseline
anxiety
assessing anxiety using the Hospital Anxiety and Depression Scale questionnaire
Measured: baseline
depression
assessing Depression using the Hospital Anxiety and Depression Scale questionnaire
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start27 Mar 2017
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Why it stopped: Study was stopped due to difficulties recruting patients, at the time, 20 patients and 20 controls were included. Within last to years, only 2 patients and 2 controls could be recruted. It lookes, that the condition is to rare available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathy;PeripheralStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037684
- Sponsor's protocol ID
- 2016-15
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2017
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.
PubMed 16697110
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Activation of Unmyelinated Skin Nerve Fibres Using Slow Depolarising Transcutaneous Electrical Stimulation in Patients With Neuropathic Pain or Chronic Postoperative Pain
- ClinicalTrials.gov ID
- NCT03037684
- Acronym / sponsor ID
- 2016-15
- Conditions
- Neuropathy;Peripheral
- Keywords
- neuropathic pain, chronic postoperative pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was stopped due to difficulties recruting patients, at the time, 20 patients and 20 controls were included. Within last to years, only 2 patients and 2 controls could be recruted. It lookes, that the condition is to rare available.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 31 Jan 2017 (estimated)
- 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.
The aim of the study is to evaluate voltage gated sodium channel (NaV1.7) dependent pain phenomena in neuropathic pain and chronic postoperative pain.
Detailed description
Sinus-like electrical stimulation may depolarize unmyelinated skin nociceptors involving NaV1.7 channels. In this case electrical stimulation may provoke pain already with very low currency intensity which normally not provoke pain in healthy subjects. This may be predictive for pain relief due to the sodium channel blocker lidocaine 5% patch.
The study will characterize pain states in peripheral neuropathic pain as well as within the painful scar in chronic postoperative pain with regard to the involvement of NaV1.7 channels.
In addition, the pain site in chronic postoperative pain (scar) will be characterized by laser-evoked potentials (LEP) and quantitative sensory testing (QST).
Pain related questionnaires will be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic pain | – | Diagnostic Test: neurophysiologyindividuals suffering from chronic pain |
| neuropathic pain | – | Diagnostic Test: neurophysiologyindividuals suffering from neuropathic pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with neuropathic pain or with chronic postoperative pain
Key inclusion criteria (2 listed)
- Group (1) patients with neuropathic pain
- Group (2) patients with chronic postoperative pain
Key exclusion criteria (2 listed)
- severe psychiatric disorder requiring hospitalisation in the past
- any neurological disease other than the pain diagnosis
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 |
|---|---|---|
| neurophysiologyelectrophysiologic measurements of peripheral nerves | Diagnostic test | chronic pain, neuropathic pain |
Primary outcome
change in pain intensity
Time frame: at baseline and during electric nerve stimulation
numeric rating scale (NRS), rating from 0-10, 0=no pain, 10=maximum pain imaginable
16 secondary outcomes
heat pain threshold
Time frame: baseline
cold pain threshold
Time frame: baseline
mechanical detection threshold
Time frame: baseline
mechanical pain threshold
Time frame: baseline
mechanical pain sensitivity
Time frame: baseline
dynamic mechanical allodynia
Time frame: baseline
vibration detection threshold
Time frame: baseline
pressure pain threshold
Time frame: baseline
LEP latency
Time frame: baseline
LEP amplitude
Time frame: baseline
stadium of pain chronification
Time frame: baseline
pain severity
Time frame: baseline
physical health status
Time frame: baseline
mental health status
Time frame: baseline
anxiety
Time frame: baseline
depression
Time frame: baseline
Results and safety
The study was stopped early (reason given: Study was stopped due to difficulties recruting patients, at the time, 20 patients and 20 controls were included. Within last to years, only 2 patients and 2 controls could be recruted. It lookes, that the condition is to rare available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 16697110Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathy;Peripheral, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 2 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: stopped early, as of the sponsor's last update on 26 Aug 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 Switzerland. 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?
The study was stopped early (reason given: Study was stopped due to difficulties recruting patients, at the time, 20 patients and 20 controls were included. Within last to years, only 2 patients and 2 controls could be recruted. It lookes, that the condition is to rare available.). Results are not available in the source record.
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?
change in pain intensity (time frame: at baseline and during electric nerve stimulation). 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 NCT03037684, which also lists 1 linked publication.
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 Aug 2026.