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NCT Number: NCT06443281

Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathy Nociceptive Pain Pain Pain, Neuropathic Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location status: Recruiting

Location contact

Michèle Hubli, PD Dr.

CONTACT

[email protected]

+41 44 510 72 03

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

neurophysiology

Diagnostic Test

Pain-related evoked potentials and nerve conduction studies

Cardiovascular test

Diagnostic Test

Blood pressure control, orthostatic intolerance test, baro-reflex sensitivity, heart-rate variability

Experimental pain paradigms

Diagnostic Test

Temporal summation of pain, conditioned pain modulation, offset analgesia

quantitative sensory testing

Diagnostic Test

Thermal and mechanical sensory testing

Clinical pain phenotype

Diagnostic Test

Pain drawings, plus and minus signs of pain

Pupillometry

Diagnostic Test

Pupil size changes after phasic and tonic sensory stimulation

Primary outcomes

  1. Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity

    Time frame: Longitudinal: change from 1 month up to 12 months

    Pain drawings, plus and minus signs of pain

  2. Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity

    Time frame: Cross-sectional: once in a chronic stage (1 year post-injury)

    Pain drawings, plus and minus signs of pain

  3. Patients with peripheral neuropathy: clinical pain phenotype including the spatial pain extent and pain intensity

    Time frame: Cross-sectional: once in a chronic stage (1 year post-injury)

    Pain drawings, plus and minus signs of pain

Secondary outcomes

  1. Spinal cord injury patients / healthy controls: somato-sensory evoked potentials

    Time frame: Longitudinal: change from 1 month up to 12 months

    Amplitude in uV

  2. Spinal cord injury patients / healthy controls: somato-sensory evoked potentials

    Time frame: Longitudinal: change from 1 month up to 12 months

    Latency in ms

  3. Spinal cord injury patients / healthy controls: contact-heat evoked potentials

    Time frame: Longitudinal: change from 1 month up to 12 months

    Amplitude in uV

  4. Spinal cord injury patients / healthy controls: contact-heat evoked potentials

    Time frame: Longitudinal: change from 1 month up to 12 months

    Latency in ms

  5. Spinal cord injury patients / healthy controls: N13 spinal potential

    Time frame: Longitudinal: change from 1 month up to 12 months

    Amplitude in uV

  6. Spinal cord injury patients / healthy controls: N13 spinal potential

    Time frame: Longitudinal: change from 1 month up to 12 months

    Latency in ms

  7. Spinal cord injury patients / healthy controls: motor neurographies

    Time frame: Longitudinal: change from 1 month up to 12 months

    Amplitude in mV

  8. Spinal cord injury patients / healthy controls: motor neurographies

    Time frame: Longitudinal: change from 1 month up to 12 months

    Latency in ms

  9. Spinal cord injury patients / healthy controls: motor neurographies

    Time frame: Longitudinal: change from 1 month up to 12 months

    Nerve conduction velocity in m/s

  10. Spinal cord injury patients / healthy controls: sensory neurography

    Time frame: Longitudinal: change from 1 month up to 12 months

    Amplitude in mV

  11. Spinal cord injury patients / healthy controls: sensory neurography

    Time frame: Longitudinal: change from 1 month up to 12 months

    Latency in ms

  12. Spinal cord injury patients / healthy controls: sensory neurography

    Time frame: Longitudinal: change from 1 month up to 12 months

    Nerve conduction velocity in m/s

  13. Spinal cord injury patients / healthy controls: resting blood pressure

    Time frame: Cross-sectional: once in a chronic stage (1 year post-injury)

    Systolic, diastolic and mean arterial pressure all in mmHg variability

  14. Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a cold pressure test

    Time frame: Cross-sectional: once in a chronic stage (1 year post-injury)

    Delta mmHg

  15. Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a Valsalva maneuvre

    Time frame: Cross-sectional: once in a chronic stage (1 year post-injury)

    Delta mmHg

  16. Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a sit-up test

    Time frame: Cross-sectional: once in a chronic stage (1 year post-injury)

    Delta mmHg

  17. Patients with peripheral neuropathy / healthy controls: baro-reflex sensitivity

    Time frame: Cross-sectional: once in a chronic stage (1 year post-injury)

    ms/mmHg

  18. Patients with peripheral neuropathy / healthy controls: heart rate variability

    Time frame: Cross-sectional: once in a chronic stage (1 year post-injury)

    RMSSD (root mean square of successive differences), high frequency/low frequency ratio

  19. Spinal cord injury patients / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli

    Time frame: Longitudinal: change from 1 month up to 12 months

    Change in numeric rating scale of pain from the first three to the last three pinprick stimuli

  20. Spinal cord injury patients / healthy controls: conditioned pain modulation

    Time frame: Longitudinal: change from 1 month up to 12 months

    Changes in pressure pain threshold (measured by an algometer in delta kg) before and during a cold water bath

  21. Patients with peripheral neuropathy / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli

    Time frame: Longitudinal: change from 1 month up to 12 months

    Change in numeric rating scale of pain from the first three to the last three pinprick stimuli

  22. Patients with peripheral neuropathy / healthy controls: conditioned pain modulation

    Time frame: Longitudinal: change from 1 month up to 12 months

    Changes in pressure pain threshold (measured by an algometer in delta kg) before and during a cold water bath

  23. Spinal cord injury patients / healthy controls: thermal sensory testing tested with a thermode

    Time frame: Longitudinal: change from 1 month up to 12 months

    Warm detection threshold (°C), cold detection threshold (°C), heat pain threshold (°C), cold pain threshold (°C)

  24. Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks

    Time frame: Longitudinal: change from 1 month up to 12 months

    Mechanical detection threshold (mN)

  25. Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks

    Time frame: Longitudinal: change from 1 month up to 12 months

    Mechanical pain threshold (mN)

  26. Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks

    Time frame: Longitudinal: change from 1 month up to 12 months

    Mechanical pain sensitivity (numeric rating scale of pain 0-10)

  27. Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks

    Time frame: Longitudinal: change from 1 month up to 12 months

    Vibration detection threshold (a.u.) tested with Rydel Seiffer tuning fork

  28. Patients with peripheral neuropathy / healthy controls: thermal sensory testing tested with a thermode

    Time frame: Longitudinal: change from 1 month up to 12 months

    Warm detection threshold (°C), cold detection threshold (°C), heat pain threshold (°C), cold pain threshold (°C)

  29. Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks

    Time frame: Longitudinal: change from 1 month up to 12 months

    Mechanical detection threshold (mN)

  30. Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks

    Time frame: Longitudinal: change from 1 month up to 12 months

    Mechanical pain threshold (mN)

  31. Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks

    Time frame: Longitudinal: change from 1 month up to 12 months

    Mechanical pain sensitivity (numeric rating scale of pain 0-10)

  32. Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks

    Time frame: Longitudinal: change from 1 month up to 12 months

    Vibration detection threshold (a.u.) tested with Rydel Seiffer tuning fork

  33. Spinal cord injury patients / patients with peripheral neuropathy / healthy controls: pupillometry

    Time frame: Cross-sectional: once in a chronic stage (1 year post-injury)

    Change in pupil size in mm after sensory input (noxious, non-noxious)

  34. Spinal cord injury patients / patients with peripheral neuropathy / healthy controls: offset analgesia (psychophysical)

    Time frame: Cross-sectional: once in a chronic stage (1 year post-injury)

    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)

  35. Spinal cord injury patients / patients with peripheral neuropathy / healthy controls: offset analgesia (pupillometry)

    Time frame: Cross-sectional, once in a chronic stage (1 year post-injury)

    Change in pupil size in mm during tonic heat application (offseat analgesia paradigm)

Study contacts

Contact information is provided by the study sponsor or research team.

Michèle Hubli, PD Dr.

CONTACT

[email protected]

+41 44 510 72 03

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jun 5, 2024
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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