Clinical trial NCT03037684: Depolarising Electrical Skin Stimulation in Neuropathic and Postoperative Pain
Official title: Selective Activation of Unmyelinated Skin Nerve Fibres Using Slow Depolarising Transcutaneous Electrical Stimulation in Patients With Neuropathic Pain or Chronic Postoperative Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuropathy;Peripheral
Keywords: neuropathic pain
chronic postoperative pain
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2017-01-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with neuropathic pain or with chronic postoperative pain

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.

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

Primary outcomes:
measure: change in pain intensity
timeFrame: at baseline and during electric nerve stimulation
Secondary outcomes:
measure: heat pain threshold
timeFrame: baseline
measure: cold pain threshold
timeFrame: baseline
measure: mechanical detection threshold
timeFrame: baseline
measure: mechanical pain threshold
timeFrame: baseline
measure: mechanical pain sensitivity
timeFrame: baseline
measure: dynamic mechanical allodynia
timeFrame: baseline
measure: vibration detection threshold
timeFrame: baseline
measure: pressure pain threshold
timeFrame: baseline
measure: LEP latency
timeFrame: baseline
measure: LEP amplitude
timeFrame: baseline
measure: stadium of pain chronification
timeFrame: baseline
measure: pain severity
timeFrame: baseline
measure: physical health status
timeFrame: baseline
measure: mental health status
timeFrame: baseline
measure: anxiety
timeFrame: baseline
measure: depression
timeFrame: baseline
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Centre for Pain Medicine
Study officials:
References:
citation: 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.