Differences in Pain Processing Between Men and Women

Not Applicable

Completed

• Conditions: Central Sensitisation
• Interventions: Other: Cutaneous thermal stimuli

• Registration Number: NCT05031286
• Lead Sponsor: Balgrist University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-09
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Arm	Cutaneous thermal stimuli	-

Primary Outcome Measures

Name	Time	Method
Change in spatial extent of mechanical hypersensitivity after intervention w.r.t. baseline	10-20 minutes before intervention (baseline) and 20-30 minutes after intervention	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
Changes to the nociceptive withdrawal reflex (NWR) after intervention w.r.t. baseline	5-10 minutes before intervention (baseline) and 30-35 minutes after intervention	Repetitive suprathreshold elicitation of the NWR to monitor its characteristics (such as magnitude and number of responses) before and after intervention

Trial Locations

Locations (1)

Balgrist Campus; 🇨🇭 Zürich, Switzerland