NCT05031286

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

1.7 years

First QC Date

August 11, 2021

Last Update Submit

April 9, 2023

Conditions

Keywords

central sensitisationcentral sensitizationnociceptionwithdrawal reflexheat painsecondary hyperalgesia

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

EXPERIMENTAL
Other: Cutaneous thermal stimuli

Interventions

Application of thermal stimuli of different intensities to the skin

Experimental Arm

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

MeSH Terms

Conditions

Hyperalgesia

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Petra Schweinhardt, MD, PhD

    Department of Chiropractic Medicine, Balgrist University Hospital, University of Zurich

    PRINCIPAL INVESTIGATOR

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

Locations