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Depolarising Electrical Skin Stimulation in Neuropathic and Postoperative Pain

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03037684
Enrollment
65
Registered
2017-01-31
Start date
2017-03-27
Completion date
2026-01-31
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathy;Peripheral

Keywords

neuropathic pain, chronic postoperative pain

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTneurophysiology

electrophysiologic measurements of peripheral nerves

Sponsors

Swiss Paraplegic Research, Nottwil
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
change in pain intensityat baseline and during electric nerve stimulationnumeric rating scale (NRS), rating from 0-10, 0=no pain, 10=maximum pain imaginable

Secondary

MeasureTime frameDescription
heat pain thresholdbaselineRamped stimuli (+1 degree Celsius / sec) that are terminated when the subject presses a button.
cold pain thresholdbaselineRamped stimuli (-1 degree Celsius / sec) that are terminated when the subject presses a button.
mechanical detection thresholdbaselineFine plastic hairs with different bending forces are applied to the skin to determine the mechanical detection threshold.
mechanical pain thresholdbaselineDifferently 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.
mechanical pain sensitivitybaselineDifferently 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)
dynamic mechanical allodyniabaselineDifferent 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).
vibration detection thresholdbaselineTuning fork is placed over a bony prominence until the subject cannot not feel vibration any more.
pressure pain thresholdbaselineA pressure gauge that exerts forces of ascending stimulus intensities is applied as a slowly increasing ramp over a muscle.
LEP latencybaselinelatency of N2 and P2 components of laser evoked potential signal curve
LEP amplitudebaselineamplitude of laser evoked potential signal curve
stadium of pain chronificationbaselineassessment of the stadium of pain chronification (stadium 1-3) using standardized questionnaire
pain severitybaselineassessment of pain severity (grade 1-4) using the Chronic Pain Grading Questionnaire
physical health statusbaselineassessing the physical health status using the Short Form-12 questionnaire
mental health statusbaselineassessing the mental health status using the Short Form-12 questionnaire
anxietybaselineassessing anxiety using the Hospital Anxiety and Depression Scale questionnaire
depressionbaselineassessing Depression using the Hospital Anxiety and Depression Scale questionnaire

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026