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Clinical Trials/NCT05031286
NCT05031286
Completed
Not Applicable

Differences in Sensitization Between Men and Women After Cutaneous Thermal Stimuli

Balgrist University Hospital1 site in 1 country66 target enrollmentMay 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Central Sensitisation
Sponsor
Balgrist University Hospital
Enrollment
66
Locations
1
Primary Endpoint
Change in spatial extent of mechanical hypersensitivity after intervention w.r.t. baseline
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Balgrist University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Schweinhardt Petra

Head of Research at the Department of Chiropractic Medicine

Balgrist University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in spatial extent of mechanical hypersensitivity after intervention w.r.t. baseline

Time Frame: 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

Time Frame: 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

Study Sites (1)

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