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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05031286
Other study ID # NWR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date December 31, 2022

Study information

Verified date April 2023
Source Balgrist University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Cutaneous thermal stimuli
Application of thermal stimuli of different intensities to the skin

Locations

Country Name City State
Switzerland Balgrist Campus Zürich

Sponsors (1)

Lead Sponsor Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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