Differences in Pain Processing Between Men and Women

Sponsor

Balgrist University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05031286

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Central Sensitisation	Other: Cutaneous thermal stimuli	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Differences in Sensitization Between Men and Women After Cutaneous Thermal Stimuli

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Arm	Other: Cutaneous thermal stimuli Application of thermal stimuli of different intensities to the skin

Arm

Intervention/Treatment

Experimental: Experimental Arm

Other: Cutaneous thermal stimuli

Application of thermal stimuli of different intensities to the skin

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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