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TerminatedNCT03037684Updated Aug 26, 2026

Depolarising Electrical Skin Stimulation in Neuropathic and Postoperative Pain

An observational study in Neuropathy;Peripheral, sponsored by Swiss Paraplegic Research, Nottwil. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Swiss Paraplegic Research, Nottwil · Observational

Why this study was terminated
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.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
65
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Neuropathy;Peripheral

Keywords

  • neuropathic pain
  • chronic postoperative pain
03

In context

Neuritis

73 studies on the registry are indexed under Neuritis; 20 are open to participants now.

This study's enrollment of 65 is below the median of 123 across 20 observational studies indexed under Neuritis.

Browse Neuritis studies →

Lead sponsor

Swiss Paraplegic Research, Nottwil is the lead sponsor of 71 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

patients with neuropathic pain or with chronic postoperative pain

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Group (1) patients with neuropathic pain
  • Group (2) patients with chronic postoperative pain

Exclusion criteria

Exclusion Criteria (both Groups):

  • severe psychiatric disorder requiring hospitalisation in the past
  • any neurological disease other than the pain diagnosis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
65 participants (actual)
Patient registry
No

Groups and cohorts

  • chronic pain

    individuals suffering from chronic pain

    Diagnostic Test: neurophysiology

  • neuropathic pain

    individuals suffering from neuropathic pain

    Diagnostic Test: neurophysiology

Interventions

  • Diagnostic testneurophysiology

    electrophysiologic measurements of peripheral nerves

06

What researchers measure

Primary outcomes

  1. change in pain intensity

    numeric rating scale (NRS), rating from 0-10, 0=no pain, 10=maximum pain imaginable

    Time frame: at baseline and during electric nerve stimulation

Secondary outcomes

  1. heat pain threshold

    Ramped stimuli (+1 degree Celsius / sec) that are terminated when the subject presses a button.

    Time frame: baseline

  2. cold pain threshold

    Ramped stimuli (-1 degree Celsius / sec) that are terminated when the subject presses a button.

    Time frame: baseline

  3. mechanical detection threshold

    Fine plastic hairs with different bending forces are applied to the skin to determine the mechanical detection threshold.

    Time frame: baseline

  4. 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.

    Time frame: baseline

  5. 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)

    Time frame: baseline

  6. 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).

    Time frame: baseline

  7. vibration detection threshold

    Tuning fork is placed over a bony prominence until the subject cannot not feel vibration any more.

    Time frame: baseline

  8. pressure pain threshold

    A pressure gauge that exerts forces of ascending stimulus intensities is applied as a slowly increasing ramp over a muscle.

    Time frame: baseline

  9. LEP latency

    latency of N2 and P2 components of laser evoked potential signal curve

    Time frame: baseline

  10. LEP amplitude

    amplitude of laser evoked potential signal curve

    Time frame: baseline

  11. stadium of pain chronification

    assessment of the stadium of pain chronification (stadium 1-3) using standardized questionnaire

    Time frame: baseline

  12. pain severity

    assessment of pain severity (grade 1-4) using the Chronic Pain Grading Questionnaire

    Time frame: baseline

  13. physical health status

    assessing the physical health status using the Short Form-12 questionnaire

    Time frame: baseline

  14. mental health status

    assessing the mental health status using the Short Form-12 questionnaire

    Time frame: baseline

  15. anxiety

    assessing anxiety using the Hospital Anxiety and Depression Scale questionnaire

    Time frame: baseline

  16. depression

    assessing Depression using the Hospital Anxiety and Depression Scale questionnaire

    Time frame: baseline

07

Study locations

1 site
  • Centre for Pain Medicine
    Nottwil, 6207, Switzerland
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03037684
Lead sponsor
Swiss Paraplegic Research, Nottwil
Responsible party
Sponsor
First posted
Jan 31, 2017
Start date
Mar 27, 2017
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026
Last update
Aug 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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