Depolarising Electrical Skin Stimulation in Neuropathic and Postoperative Pain

Neuropathy;Peripheral Clinical Trial

Official title:

Selective Activation of Unmyelinated Skin Nerve Fibres Using Slow Depolarising Transcutaneous Electrical Stimulation in Patients With Neuropathic Pain or Chronic Postoperative Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03037684
• Other study ID #: 2016-15
• Status: Recruiting
• Start date: March 27, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Swiss Paraplegic Research, Nottwil
• Contact: Gunther Landmann, MD
• Phone: +4141939
• Email: gunther.landmann[@]paraplegie.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuropathy;Peripheral
• Pain, Postoperative
• Peripheral Nervous System Diseases

Intervention

Diagnostic Test:
• neurophysiology
electrophysiologic measurements of peripheral nerves

Locations

Country	Name	City	State
Switzerland	Centre for Pain Medicine	Nottwil

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. Erratum In: Pain. 2006 Nov;125(1-2):197. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in pain intensity	numeric rating scale (NRS), rating from 0-10, 0=no pain, 10=maximum pain imaginable	at baseline and during electric nerve stimulation
Secondary	heat pain threshold	Ramped stimuli (+1 degree Celsius / sec) that are terminated when the subject presses a button.	baseline
Secondary	cold pain threshold	Ramped stimuli (-1 degree Celsius / sec) that are terminated when the subject presses a button.	baseline
Secondary	mechanical detection threshold	Fine plastic hairs with different bending forces are applied to the skin to determine the mechanical detection threshold.	baseline
Secondary	mechanical pain threshold	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.	baseline
Secondary	mechanical pain sensitivity	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)	baseline
Secondary	dynamic mechanical allodynia	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).	baseline
Secondary	vibration detection threshold	Tuning fork is placed over a bony prominence until the subject cannot not feel vibration any more.	baseline
Secondary	pressure pain threshold	A pressure gauge that exerts forces of ascending stimulus intensities is applied as a slowly increasing ramp over a muscle.	baseline
Secondary	LEP latency	latency of N2 and P2 components of laser evoked potential signal curve	baseline
Secondary	LEP amplitude	amplitude of laser evoked potential signal curve	baseline
Secondary	stadium of pain chronification	assessment of the stadium of pain chronification (stadium 1-3) using standardized questionnaire	baseline
Secondary	pain severity	assessment of pain severity (grade 1-4) using the Chronic Pain Grading Questionnaire	baseline
Secondary	physical health status	assessing the physical health status using the Short Form-12 questionnaire	baseline
Secondary	mental health status	assessing the mental health status using the Short Form-12 questionnaire	baseline
Secondary	anxiety	assessing anxiety using the Hospital Anxiety and Depression Scale questionnaire	baseline
Secondary	depression	assessing Depression using the Hospital Anxiety and Depression Scale questionnaire	baseline