Depolarising Electrical Skin Stimulation in Neuropathic and Postoperative Pain

Recruiting

• Conditions: Neuropathy;Peripheral
• Interventions: Diagnostic Test: neurophysiology

• Registration Number: NCT03037684
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

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.

Study Timeline

• Study First Submitted: 2017-01-16
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Study Start: 2017-03-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic pain	neurophysiology	individuals suffering from chronic pain
neuropathic pain	neurophysiology	individuals suffering from neuropathic pain

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre for Pain Medicine; 🇨🇭 Nottwil, Switzerland