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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03037684
Other study ID # 2016-15
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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