Depolarising Electrical Skin Stimulation in Neuropathic and Postoperative Pain

Sponsor
Swiss Paraplegic Centre Nottwil (Other)
Overall Status
Recruiting
CT.gov ID
NCT03037684
Collaborator
(none)
75
1
81.1
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
75 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Selective Activation of Unmyelinated Skin Nerve Fibres Using Slow Depolarising Transcutaneous Electrical Stimulation in Patients With Neuropathic Pain or Chronic Postoperative Pain
Actual Study Start Date :
Mar 27, 2017
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. heat pain threshold [baseline]

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

  2. cold pain threshold [baseline]

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

  3. mechanical detection threshold [baseline]

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

  4. 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.

  5. 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)

  6. 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).

  7. vibration detection threshold [baseline]

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

  8. pressure pain threshold [baseline]

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

  9. LEP latency [baseline]

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

  10. LEP amplitude [baseline]

    amplitude of laser evoked potential signal curve

  11. stadium of pain chronification [baseline]

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

  12. pain severity [baseline]

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

  13. physical health status [baseline]

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

  14. mental health status [baseline]

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

  15. anxiety [baseline]

    assessing anxiety using the Hospital Anxiety and Depression Scale questionnaire

  16. depression [baseline]

    assessing Depression using the Hospital Anxiety and Depression Scale questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Pain Medicine Nottwil Switzerland 6207

Sponsors and Collaborators

  • Swiss Paraplegic Centre Nottwil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Landmann Gunther, Head of Neurology, Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier:
NCT03037684
Other Study ID Numbers:
  • 2016-15
First Posted:
Jan 31, 2017
Last Update Posted:
Sep 14, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Landmann Gunther, Head of Neurology, Swiss Paraplegic Centre Nottwil
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2021