Depolarising Electrical Skin Stimulation in Neuropathic and Postoperative Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: neurophysiology.
- Who it may be relevant to
- Registry conditions: Neuropathy;Peripheral. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Selective Activation of Unmyelinated Skin Nerve Fibres Using Slow Depolarising Transcutaneous Electrical Stimulation in Patients With Neuropathic Pain or Chronic Postoperative Pain
Overview
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 test neurophysiology
electrophysiologic measurements of peripheral nerves
Primary outcome measures
- change in pain intensity [Time frame: at baseline and during electric nerve stimulation]
Secondary outcome measures (12)
- heat pain threshold [Time frame: baseline]
- cold pain threshold [Time frame: baseline]
- mechanical detection threshold [Time frame: baseline]
- mechanical pain threshold [Time frame: baseline]
- mechanical pain sensitivity [Time frame: baseline]
- dynamic mechanical allodynia [Time frame: baseline]
- vibration detection threshold [Time frame: baseline]
- pressure pain threshold [Time frame: baseline]
- LEP latency [Time frame: baseline]
- LEP amplitude [Time frame: baseline]
- stadium of pain chronification [Time frame: baseline]
- pain severity [Time frame: baseline]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Centre for Pain Medicine — Nottwil
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):23 PMID 16697110
Identifiers
NCT: NCT03037684 · 2016-15