Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury

University of Zurich (UZH)

Status: Enrolling

Conditions: Spinal Cord Injuries; Nociceptive Pain; Pain, Neuropathic; Neuropathy

Treatments: Diagnostic Test: Cardiovascular test; Diagnostic Test: Experimental pain paradigms; Diagnostic Test: Neurophysiology; Diagnostic Test: Clinical pain phenotype; Diagnostic Test: Quantitative sensory testing

Study type: Observational

Funder types: Other

Identifiers

NCT06443281

2024-00134

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

300 participants in 4 patient groups

Patients with spinal cord injury with neuropathic pain

Treatment:

Diagnostic Test: Quantitative sensory testing

Diagnostic Test: Clinical pain phenotype

Diagnostic Test: Neurophysiology

Diagnostic Test: Experimental pain paradigms

Diagnostic Test: Cardiovascular test

Patients with spinal cord injury but without neuropathic pain

Treatment:

Diagnostic Test: Quantitative sensory testing

Diagnostic Test: Neurophysiology

Diagnostic Test: Experimental pain paradigms

Diagnostic Test: Cardiovascular test

Patients with peripheral neuropathy

Treatment:

Diagnostic Test: Quantitative sensory testing

Diagnostic Test: Clinical pain phenotype

Diagnostic Test: Neurophysiology

Diagnostic Test: Experimental pain paradigms

Diagnostic Test: Cardiovascular test

Healthy subjects

Treatment:

Diagnostic Test: Quantitative sensory testing

Diagnostic Test: Neurophysiology

Diagnostic Test: Experimental pain paradigms

Diagnostic Test: Cardiovascular test