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Depolarising Electrical Skin Stimulation in Neuropathic and Postoperative Pain

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ClinicalTrials.gov Identifier: NCT03037684
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Landmann Gunther, Swiss Paraplegic Centre 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.

Condition or disease Intervention/treatment
Neuropathy;Peripheral 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.


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Study Type : Observational
Estimated Enrollment : 40 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 : March 27, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with neuropathic pain or with chronic postoperative pain
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037684


Contacts
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Contact: Gunther Landmann, MD +4141939 ext 4925 gunther.landmann@paraplegie.ch

Locations
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Switzerland
Centre for Pain Medicine Recruiting
Nottwil, Switzerland, 6207
Contact: Gunther Landmann, MD    +4141939 ext 4925    gunther.landmann@paraplegie.ch   
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil

Publications:
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Responsible Party: Landmann Gunther, Head of Neurology, Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT03037684     History of Changes
Other Study ID Numbers: 2016-15
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Landmann Gunther, Swiss Paraplegic Centre Nottwil:
neuropathic pain
chronic postoperative pain

Additional relevant MeSH terms:
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Pain, Postoperative
Peripheral Nervous System Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Neuromuscular Diseases
Nervous System Diseases