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

The aim of the study is to evaluate voltage gated sodium channel (NaV1.7) dependent pain phenomena in neuropathic pain and chronic postoperative pain.

Study Overview

• Status: Recruiting
• Conditions: Neuropathy;Peripheral
• Intervention / Treatment: Diagnostic test: neurophysiology

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 Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Gunther Landmann, MD; Phone Number: 4925 +4141939; Email: gunther.landmann@paraplegie.ch

Study Locations

• Switzerland
  • Nottwil, Switzerland, 6207
    • Recruiting
    • Centre for Pain Medicine
    • Contact: Gunther Landmann, MD; Phone Number: 4925 +4141939; Email: gunther.landmann@paraplegie.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with neuropathic pain or with chronic postoperative pain

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
chronic pain; individuals suffering from chronic pain	Diagnostic test: neurophysiology; electrophysiologic measurements of peripheral nerves
neuropathic pain; individuals suffering from neuropathic pain	Diagnostic test: neurophysiology; electrophysiologic measurements of peripheral nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in pain intensity	numeric rating scale (NRS), rating from 0-10, 0=no pain, 10=maximum pain imaginable	at baseline and during electric nerve stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heat pain threshold	Ramped stimuli (+1 degree Celsius / sec) that are terminated when the subject presses a button.	baseline
cold pain threshold	Ramped stimuli (-1 degree Celsius / sec) that are terminated when the subject presses a button.	baseline
mechanical detection threshold	Fine plastic hairs with different bending forces are applied to the skin to determine the mechanical detection threshold.	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.	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)	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).	baseline
vibration detection threshold	Tuning fork is placed over a bony prominence until the subject cannot not feel vibration any more.	baseline
pressure pain threshold	A pressure gauge that exerts forces of ascending stimulus intensities is applied as a slowly increasing ramp over a muscle.	baseline
LEP latency	latency of N2 and P2 components of laser evoked potential signal curve	baseline
LEP amplitude	amplitude of laser evoked potential signal curve	baseline
stadium of pain chronification	assessment of the stadium of pain chronification (stadium 1-3) using standardized questionnaire	baseline
pain severity	assessment of pain severity (grade 1-4) using the Chronic Pain Grading Questionnaire	baseline
physical health status	assessing the physical health status using the Short Form-12 questionnaire	baseline
mental health status	assessing the mental health status using the Short Form-12 questionnaire	baseline
anxiety	assessing anxiety using the Hospital Anxiety and Depression Scale questionnaire	baseline
depression	assessing Depression using the Hospital Anxiety and Depression Scale questionnaire	baseline

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimated): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: neuropathic pain; chronic postoperative pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Neuralgia; Neuritis; Musculoskeletal and Neural Physiological Phenomena; Cell Physiological Phenomena; Physiological Phenomena; Electrophysiological Phenomena; Biochemical Phenomena; Chemical Phenomena; Nervous System Physiological Phenomena; Synaptic Potentials; Membrane Potentials; Synaptic Transmission; Signal Transduction; Postsynaptic Potential Summation
• Other Study ID Numbers: 2016-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No