Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443281
• Other study ID #: 2024-00134
• Status: Recruiting
• Start date: April 17, 2024
• Est. completion date: April 30, 2030

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: Michèle Hubli, PD Dr.
• Phone: +41 44 510 72 03
• Email: michele.hubli[@]balgrist.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2030
• Est. primary completion date: April 30, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neuralgia
• Neuropathy
• Nociceptive Pain
• Pain, Neuropathic
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Diagnostic Test:
• Neurophysiology
Pain-related evoked potentials and nerve conduction studies
• Cardiovascular test
Blood pressure control, orthostatic intolerance test, baro-reflex sensitivity, heart-rate variability
• Experimental pain paradigms
Temporal summation of pain, conditioned pain modulation
• Quantitative sensory testing
Thermal and mechanical sensory testing
• Clinical pain phenotype
Pain drawings, plus and minus signs of pain

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity	Pain drawings, plus and minus signs of pain	Longitudinal: change from 1 month up to 12 months
Primary	Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity	Pain drawings, plus and minus signs of pain	Cross-sectional: once in a chronic stage (1 year post-injury)
Primary	Patients with peripheral neuropathy: clinical pain phenotype including the spatial pain extent and pain intensity	Pain drawings, plus and minus signs of pain	Cross-sectional: once in a chronic stage (1 year post-injury)
Secondary	Spinal cord injury patients / healthy controls: somato-sensory evoked potentials	Amplitude in uV	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: somato-sensory evoked potentials	Latency in ms	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: contact-heat evoked potentials	Amplitude in uV	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: contact-heat evoked potentials	Latency in ms	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: N13 spinal potential	Amplitude in uV	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: N13 spinal potential	Latency in ms	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: motor neurographies	Amplitude in mV	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: motor neurographies	Latency in ms	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: motor neurographies	Nerve conduction velocity in m/s	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: sensory neurography	Amplitude in mV	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: sensory neurography	Latency in ms	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: sensory neurography	Nerve conduction velocity in m/s	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: resting blood pressure	Systolic, diastolic and mean arterial pressure all in mmHg variability	Cross-sectional: once in a chronic stage (1 year post-injury)
Secondary	Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a cold pressure test	Delta mmHg	Cross-sectional: once in a chronic stage (1 year post-injury)
Secondary	Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a Valsalva maneuvre	Delta mmHg	Cross-sectional: once in a chronic stage (1 year post-injury)
Secondary	Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a sit-up test	Delta mmHg	Cross-sectional: once in a chronic stage (1 year post-injury)
Secondary	Patients with peripheral neuropathy / healthy controls: baro-reflex sensitivity	ms/mmHg	Cross-sectional: once in a chronic stage (1 year post-injury)
Secondary	Patients with peripheral neuropathy / healthy controls: heart rate variability	RMSSD (root mean square of successive differences), high frequency/low frequency ratio	Cross-sectional: once in a chronic stage (1 year post-injury)
Secondary	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	Longitudinal: change from 1 month up to 12 months
Secondary	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	Longitudinal: change from 1 month up to 12 months
Secondary	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	Longitudinal: change from 1 month up to 12 months
Secondary	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	Longitudinal: change from 1 month up to 12 months
Secondary	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)	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks	Mechanical detection threshold (mN)	Longitudinal: change from 1 month up to 12 months
Secondary	Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks	Mechanical pain threshold (mN)	Longitudinal: change from 1 month up to 12 months
Secondary	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)	Longitudinal: change from 1 month up to 12 months
Secondary	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	Longitudinal: change from 1 month up to 12 months
Secondary	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)	Longitudinal: change from 1 month up to 12 months
Secondary	Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks	Mechanical detection threshold (mN)	Longitudinal: change from 1 month up to 12 months
Secondary	Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks	Mechanical pain threshold (mN)	Longitudinal: change from 1 month up to 12 months
Secondary	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)	Longitudinal: change from 1 month up to 12 months
Secondary	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	Longitudinal: change from 1 month up to 12 months