Pain Phenotyping in Patients with Neuropathic Pain After Spinal Cord Injury

Recruiting

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

• Registration Number: NCT06443281
• Lead Sponsor: University of Zurich

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-17
• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-06-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-04
• Primary Completion: 2030-04-30
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity	Cross-sectional: once in a chronic stage (1 year post-injury)	Pain drawings, plus and minus signs of pain
Patients with peripheral neuropathy: clinical pain phenotype including the spatial pain extent and pain intensity	Cross-sectional: once in a chronic stage (1 year post-injury)	Pain drawings, plus and minus signs of pain

Secondary Outcome Measures

Name	Time	Method
Spinal cord injury patients / healthy controls: resting blood pressure	Cross-sectional: once in a chronic stage (1 year post-injury)	Systolic, diastolic and mean arterial pressure all in mmHg variability
Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a Valsalva maneuvre	Cross-sectional: once in a chronic stage (1 year post-injury)	Delta mmHg
Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a sit-up test	Cross-sectional: once in a chronic stage (1 year post-injury)	Delta mmHg
Spinal cord injury patients / healthy controls: conditioned pain modulation	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
Patients with peripheral neuropathy / healthy controls: thermal sensory testing tested with a thermode	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)
Spinal cord injury patients / healthy controls: somato-sensory evoked potentials	Longitudinal: change from 1 month up to 12 months	Latency in ms
Spinal cord injury patients / healthy controls: contact-heat evoked potentials	Longitudinal: change from 1 month up to 12 months	Latency in ms
Spinal cord injury patients / healthy controls: N13 spinal potential	Longitudinal: change from 1 month up to 12 months	Latency in ms
Patients with peripheral neuropathy / healthy controls: baro-reflex sensitivity	Cross-sectional: once in a chronic stage (1 year post-injury)	ms/mmHg
Spinal cord injury patients / healthy controls: motor neurographies	Longitudinal: change from 1 month up to 12 months	Nerve conduction velocity in m/s
Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a cold pressure test	Cross-sectional: once in a chronic stage (1 year post-injury)	Delta mmHg
Spinal cord injury patients / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli	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
Spinal cord injury patients / healthy controls: thermal sensory testing tested with a thermode	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)
Patients with peripheral neuropathy / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli	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
Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks	Longitudinal: change from 1 month up to 12 months	Vibration detection threshold (a.u.) tested with Rydel Seiffer tuning fork
Spinal cord injury patients / healthy controls: sensory neurography	Longitudinal: change from 1 month up to 12 months	Nerve conduction velocity in m/s
Patients with peripheral neuropathy / healthy controls: heart rate variability	Cross-sectional: once in a chronic stage (1 year post-injury)	RMSSD (root mean square of successive differences), high frequency/low frequency ratio
Patients with peripheral neuropathy / healthy controls: conditioned pain modulation	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
Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks	Longitudinal: change from 1 month up to 12 months	Vibration detection threshold (a.u.) tested with Rydel Seiffer tuning fork

Trial Locations

Locations (1)

Balgrist University Hospital; 🇨🇭 Zurich, Switzerland