Differences in Pain Processing Between Men and Women

Central Sensitisation Clinical Trial

Official title:

Differences in Sensitization Between Men and Women After Cutaneous Thermal Stimuli

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031286
• Other study ID #: NWR
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Many chronic pain conditions show clear differences between between men and women, such as reported pain intensities or treatment effects, with chronic pain conditions being generally more frequent in women. Yet, the underlying mechanisms causing these differences are poorly understood. Central sensitization (CS) is considered one important mechanism in pain patients which differs between female and male patients. The central hypothesis is that already in the healthy population CS processes are more pronounced in women than in men.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• good general health
• able to give informed consent

Exclusion Criteria:

• pain complaints for more than two consecutive days over the past three months
• any major medical or psychiatric condition (e.g. heart disease, major depressive disorder)
• any chronic pain condition
• inability to follow study instructions
• consumption of stimulants, drugs, or analgesics within the past 24 hours
• scar tissue or generally reduced sensitivity in the designated testing site areas

Related Conditions & MeSH terms

• Central Sensitisation

Intervention

Other:
• Cutaneous thermal stimuli
Application of thermal stimuli of different intensities to the skin

Locations

Country	Name	City	State
Switzerland	Balgrist Campus	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in spatial extent of mechanical hypersensitivity after intervention w.r.t. baseline	Mapping of hypersensitivity in cm2 of sensitized skin area using two quantitative sensory testing tools (256mN von Frey filament and 200-400mN brush) before and after intervention	10-20 minutes before intervention (baseline) and 20-30 minutes after intervention
Primary	Changes to the nociceptive withdrawal reflex (NWR) after intervention w.r.t. baseline	Repetitive suprathreshold elicitation of the NWR to monitor its characteristics (such as magnitude and number of responses) before and after intervention	5-10 minutes before intervention (baseline) and 30-35 minutes after intervention