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OpenTrials
Completed

NCT Number: NCT05031286

Differences in Pain Processing Between Men and Women

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balgrist Campus

Zurich, 8008, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cutaneous thermal stimuli

Other

Application of thermal stimuli of different intensities to the skin

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Official study title

Differences in Sensitization Between Men and Women After Cutaneous Thermal Stimuli

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 1, 2021
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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