Differences in Pain Processing Between Men and Women
Differences in Sensitization Between Men and Women After Cutaneous Thermal Stimuli
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 11, 2021
CompletedFirst Posted
Study publicly available on registry
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 11, 2023
April 1, 2023
1.7 years
August 11, 2021
April 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
Experimental Arm
EXPERIMENTALInterventions
Application of thermal stimuli of different intensities to the skin
Eligibility Criteria
You may qualify if:
- good general health
- able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Balgrist Campus
Zurich, 8008, Switzerland
Related Publications (1)
Guekos A, Saxer J, Salinas Gallegos D, Schweinhardt P. Healthy women show more experimentally induced central sensitization compared with men. Pain. 2024 Jun 1;165(6):1413-1424. doi: 10.1097/j.pain.0000000000003144. Epub 2024 Jan 11.
PMID: 38231588DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petra Schweinhardt, MD, PhD
Department of Chiropractic Medicine, Balgrist University Hospital, University of Zurich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Research at the Department of Chiropractic Medicine
Study Record Dates
First Submitted
August 11, 2021
First Posted
September 1, 2021
Study Start
May 1, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
April 11, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share