Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Zurich
About this trial
The development of neuropathic pain is one of the most debilitating sequels after a spinal cord injury (SCI). The overall aim of this study is to investigate potential underlying pathophysiological mechanisms of neuropathic pain after SCI. The functionality of the nociceptive pathway in humans as well as its plastic changes following SCI will be inferred with sophisticated sensory and pain phenotyping using quantitative sensory testing (i.e., psychophysical measures), objective neurophysiological measures of pain processing and the recording of pain-related autonomic responses (i.e., galvanic skin response, cardiovascular measures and pupil dilation). In addition, the interplay between the somatosensory and autonomic nervous system and its association with the development and maintenance of neuropathic pain after SCI will be investigated.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged between 18-80 years
Traumatic and non-traumatic etiology
Para- and tetraplegic SCI
Complete and incomplete SCI
Disqualifiers
Inability to follow study instructions
Pregnancy
Medically manifested psychological disorder
Medical condition affecting the peripheral and/or central nervous system other than the desired experimental condition (e.g., additional peripheral neuropathy in the SCI cohort)
Trial population
In- and outpatients of Balgrist University Hospital Zurich
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Neurophysiology
Diagnostic testPain-related evoked potentials and nerve conduction studies
Cardiovascular test
Diagnostic testBlood pressure control, orthostatic intolerance test, baro-reflex sensitivity, heart-rate variability
Experimental pain paradigms
Diagnostic testTemporal summation of pain, conditioned pain modulation, offset analgesia
Quantitative sensory testing
Diagnostic testThermal and mechanical sensory testing
Clinical pain phenotype
Diagnostic testPain drawings, plus and minus signs of pain
Pupillometry
Diagnostic testPupil size changes after phasic and tonic sensory stimulation
Treatment groups
300 Participants
are divided into 4 treatment groupsGroup A: Patients with spinal cord injury with neuropathic pain6 interventions
Group B: Patients with spinal cord injury but without neuropathic pain5 interventions
Group C: Patients with peripheral neuropathy6 interventions
Group D: Healthy subjects5 interventions
Trial outcomes
Primary outcomes
1
Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity
Pain drawings, plus and minus signs of pain
Time frame
Longitudinal: change from 1 month up to 12 months2
Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity
Pain drawings, plus and minus signs of pain
Time frame
Cross-sectional: once in a chronic stage (1 year post-injury)3
Patients with peripheral neuropathy: clinical pain phenotype including the spatial pain extent and pain intensity
Pain drawings, plus and minus signs of pain
Time frame
Cross-sectional: once in a chronic stage (1 year post-injury)Secondary outcomes
1
Spinal cord injury patients / healthy controls: somato-sensory evoked potentials
Amplitude in uV
Time frame
Longitudinal: change from 1 month up to 12 months2
Spinal cord injury patients / healthy controls: somato-sensory evoked potentials
Latency in ms
Time frame
Longitudinal: change from 1 month up to 12 months3
Spinal cord injury patients / healthy controls: contact-heat evoked potentials
Amplitude in uV
Time frame
Longitudinal: change from 1 month up to 12 months4
Spinal cord injury patients / healthy controls: contact-heat evoked potentials
Latency in ms
Time frame
Longitudinal: change from 1 month up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Zurich
Lead sponsor
Swiss National Science Foundation
Collaborator
Source ClinicalTrials.gov