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
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 |
The aim of the study is to evaluate voltage gated sodium channel (NaV1.7) dependent pain phenomena in neuropathic pain and chronic postoperative pain.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Centre for Pain Medicine | Nottwil |
Lead Sponsor | Collaborator |
---|---|
Swiss Paraplegic Research, Nottwil |
Switzerland,
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
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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