Spinal Cord InjuriesNCT06443281
Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury
An observational study of Spinal Cord Injuries and Pain, Neuropathic, run by University of Zurich at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Pain, Neuropathic, Nociceptive Pain
- What is being tested?
- Neurophysiology, Cardiovascular test and Experimental pain paradigms
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Apr 2024to 30 Apr 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In- and outpatients of Balgrist University Hospital Zurich
Who may be able to join
- Spinal injury cohort - general inclusion criteria:
- Aged between 18-80 years
- Traumatic and non-traumatic etiology
- Para- and tetraplegic SCI
- Complete and incomplete SCI
- SCI with and without neuropathic pain
Show all 23Show fewer
- Additional inclusion criteria for longitudinal study:
- SCI since less than one month
- Additional inclusion criteria for cross-sectional study:
- SCI since more than one year
- Control cohorts with peripheral neuropathy:
- General inclusion criteria:
- Aged between 18-80 years
- Neurological disorder affecting the peripheral nervous system (i.e., peripheral neuropathy)
- Peripheral neuropathy with or without neuropathic pain
- Additional inclusion criteria for longitudinal study:
- Peripheral neuropathy since less than one month
- Additional inclusion criteria for cross-sectional study:
- Peripheral neuropathy since more than one year
- Control cohorts without neuropathy / healthy volunteers
- General inclusion criteria:
- Aged between 18-80 years
- No medical condition affecting the peripheral and/or central nervous system (e.g., pain, systemic disease, psychological disorder)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
Michèle Hubli, PD Dr., +41 44 510 72 03, michele.hubli@balgrist.ch
About this study
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.
- Conditions
- Spinal Cord Injuries, Pain, Neuropathic, Nociceptive Pain, Neuropathy
- Being tested
- Neurophysiology, Cardiovascular test, Experimental pain paradigms, Quantitative sensory testing, Clinical pain phenotype
- Medical subject headings
- Spinal Cord Injuries, Neuralgia, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurophysiologyDiagnostic test
Pain-related evoked potentials and nerve conduction studies
Cardiovascular testDiagnostic test
Blood pressure control, orthostatic intolerance test, baro-reflex sensitivity, heart-rate variability
Experimental pain paradigmsDiagnostic test
Temporal summation of pain, conditioned pain modulation, offset analgesia
Quantitative sensory testingDiagnostic test
Thermal and mechanical sensory testing
Clinical pain phenotypeDiagnostic test
Pain drawings, plus and minus signs of pain
PupillometryDiagnostic test
Pupil size changes after phasic and tonic sensory stimulation
| Study group | Role | What they receive |
|---|---|---|
| Patients with spinal cord injury with neuropathic pain | Not described Receives: Diagnostic Test: Neurophysiology; Diagnostic Test: Cardiovascular test; Diagnostic Test: Experimental pain paradigms; Diagnostic Test: Quantitative sensory testing; Diagnostic Test: Clinical pain phenotype; Diagnostic Test: Pupillometry | |
| Patients with spinal cord injury but without neuropathic pain | Not described Receives: Diagnostic Test: Neurophysiology; Diagnostic Test: Cardiovascular test; Diagnostic Test: Experimental pain paradigms; Diagnostic Test: Quantitative sensory testing; Diagnostic Test: Pupillometry | |
| Patients with peripheral neuropathy | Not described Receives: Diagnostic Test: Neurophysiology; Diagnostic Test: Cardiovascular test; Diagnostic Test: Experimental pain paradigms; Diagnostic Test: Quantitative sensory testing; Diagnostic Test: Clinical pain phenotype; Diagnostic Test: Pupillometry | |
| Healthy subjects | Not described Receives: Diagnostic Test: Neurophysiology; Diagnostic Test: Cardiovascular test; Diagnostic Test: Experimental pain paradigms; Diagnostic Test: Quantitative sensory testing; Diagnostic Test: Pupillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity
Pain drawings, plus and minus signs of pain
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity
Pain drawings, plus and minus signs of pain
Measured: Cross-sectional: once in a chronic stage (1 year post-injury)
Patients with peripheral neuropathy: clinical pain phenotype including the spatial pain extent and pain intensity
Pain drawings, plus and minus signs of pain
Measured: Cross-sectional: once in a chronic stage (1 year post-injury)
Secondary outcomes (35)
Spinal cord injury patients / healthy controls: somato-sensory evoked potentials
Amplitude in uV
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: somato-sensory evoked potentials
Latency in ms
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: contact-heat evoked potentials
Amplitude in uV
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: contact-heat evoked potentials
Latency in ms
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: N13 spinal potential
Amplitude in uV
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: N13 spinal potential
Latency in ms
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: motor neurographies
Amplitude in mV
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: motor neurographies
Latency in ms
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: motor neurographies
Nerve conduction velocity in m/s
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: sensory neurography
Amplitude in mV
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: sensory neurography
Latency in ms
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: sensory neurography
Nerve conduction velocity in m/s
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: resting blood pressure
Systolic, diastolic and mean arterial pressure all in mmHg variability
Measured: Cross-sectional: once in a chronic stage (1 year post-injury)
Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a cold pressure test
Delta mmHg
Measured: Cross-sectional: once in a chronic stage (1 year post-injury)
Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a Valsalva maneuvre
Delta mmHg
Measured: Cross-sectional: once in a chronic stage (1 year post-injury)
Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a sit-up test
Delta mmHg
Measured: Cross-sectional: once in a chronic stage (1 year post-injury)
Patients with peripheral neuropathy / healthy controls: baro-reflex sensitivity
ms/mmHg
Measured: Cross-sectional: once in a chronic stage (1 year post-injury)
Patients with peripheral neuropathy / healthy controls: heart rate variability
RMSSD (root mean square of successive differences), high frequency/low frequency ratio
Measured: Cross-sectional: once in a chronic stage (1 year post-injury)
Spinal cord injury patients / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli
Change in numeric rating scale of pain from the first three to the last three pinprick stimuli
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: conditioned pain modulation
Changes in pressure pain threshold (measured by an algometer in delta kg) before and during a cold water bath
Measured: Longitudinal: change from 1 month up to 12 months
Patients with peripheral neuropathy / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli
Change in numeric rating scale of pain from the first three to the last three pinprick stimuli
Measured: Longitudinal: change from 1 month up to 12 months
Patients with peripheral neuropathy / healthy controls: conditioned pain modulation
Changes in pressure pain threshold (measured by an algometer in delta kg) before and during a cold water bath
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: thermal sensory testing tested with a thermode
Warm detection threshold (°C), cold detection threshold (°C), heat pain threshold (°C), cold pain threshold (°C)
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
Mechanical detection threshold (mN)
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
Mechanical pain threshold (mN)
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
Mechanical pain sensitivity (numeric rating scale of pain 0-10)
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
Vibration detection threshold (a.u.) tested with Rydel Seiffer tuning fork
Measured: Longitudinal: change from 1 month up to 12 months
Patients with peripheral neuropathy / healthy controls: thermal sensory testing tested with a thermode
Warm detection threshold (°C), cold detection threshold (°C), heat pain threshold (°C), cold pain threshold (°C)
Measured: Longitudinal: change from 1 month up to 12 months
Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
Mechanical detection threshold (mN)
Measured: Longitudinal: change from 1 month up to 12 months
Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
Mechanical pain threshold (mN)
Measured: Longitudinal: change from 1 month up to 12 months
Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
Mechanical pain sensitivity (numeric rating scale of pain 0-10)
Measured: Longitudinal: change from 1 month up to 12 months
Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks
Vibration detection threshold (a.u.) tested with Rydel Seiffer tuning fork
Measured: Longitudinal: change from 1 month up to 12 months
Spinal cord injury patients / patients with peripheral neuropathy / healthy controls: pupillometry
Change in pupil size in mm after sensory input (noxious, non-noxious)
Measured: Cross-sectional: once in a chronic stage (1 year post-injury)
Spinal cord injury patients / patients with peripheral neuropathy / healthy controls: offset analgesia (psychophysical)
Change in pain ratings during tonic heat stimulation (offet analgesia paradigm) in numeric rating scale (NRS, scale titel: offset analgesia, 0-100, higher score means better analgesia)
Measured: Cross-sectional: once in a chronic stage (1 year post-injury)
Spinal cord injury patients / patients with peripheral neuropathy / healthy controls: offset analgesia (pupillometry)
Change in pupil size in mm during tonic heat application (offseat analgesia paradigm)
Measured: Cross-sectional, once in a chronic stage (1 year post-injury)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start17 Apr 2024
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Patrick Freund, Prof. Dr. Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443281
- Sponsor's protocol ID
- 2024-00134
- Status last verified
- May 2026
- First submitted
- 25 Apr 2024
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No