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NCT Number: NCT03037684

Depolarising Electrical Skin Stimulation in Neuropathic and 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.

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Key information

Conditions

Neuropathy;Peripheral Nervous System Diseases Neuralgia Neuritis Neurologic Manifestations Neuromuscular Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Pain Medicine

Nottwil, 6207, Switzerland

Location status: Recruiting

Location contact

Gunther Landmann, MD

CONTACT

[email protected]

+4141939 ext. 4925

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

(both Groups):

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

Treatment and study plan

neurophysiology

Diagnostic Test

electrophysiologic measurements of peripheral nerves

Primary outcomes

  1. 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

Secondary outcomes

  1. heat pain threshold

    Time frame: baseline

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

  2. cold pain threshold

    Time frame: baseline

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

  3. mechanical detection threshold

    Time frame: baseline

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

  4. mechanical pain threshold

    Time frame: baseline

    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.

  5. mechanical pain sensitivity

    Time frame: baseline

    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)

  6. dynamic mechanical allodynia

    Time frame: baseline

    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).

  7. vibration detection threshold

    Time frame: baseline

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

  8. pressure pain threshold

    Time frame: baseline

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

  9. LEP latency

    Time frame: baseline

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

  10. LEP amplitude

    Time frame: baseline

    amplitude of laser evoked potential signal curve

  11. stadium of pain chronification

    Time frame: baseline

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

  12. pain severity

    Time frame: baseline

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

  13. physical health status

    Time frame: baseline

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

  14. mental health status

    Time frame: baseline

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

  15. anxiety

    Time frame: baseline

    assessing anxiety using the Hospital Anxiety and Depression Scale questionnaire

  16. depression

    Time frame: baseline

    assessing Depression using the Hospital Anxiety and Depression Scale questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Gunther Landmann, MD

CONTACT

[email protected]

+4141939 ext. 4925

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

Selective Activation of Unmyelinated Skin Nerve Fibres Using Slow Depolarising Transcutaneous Electrical Stimulation in Patients With Neuropathic Pain or Chronic Postoperative Pain

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2017
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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