Central SensitisationNCT05031286
Differences in Pain Processing Between Men and Women
A study testing Cutaneous thermal stimuli in people with Central Sensitisation, run by Balgrist University Hospital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Sensitisation
- What is being tested?
- Cutaneous thermal stimuli
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good general health
- able to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Sensitization Between Men and Women After Cutaneous Thermal Stimuli
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.
- Conditions
- Central Sensitisation
- Being tested
- Cutaneous thermal stimuli
- Keywords
- central sensitisation, central sensitization, nociception, withdrawal reflex, heat pain, secondary hyperalgesia
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutaneous thermal stimuliOther
Application of thermal stimuli of different intensities to the skin
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Other: Cutaneous thermal stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5-10 minutes before intervention (baseline) and 30-35 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 May 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central SensitisationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Schweinhardt Petra, Balgrist University Hospital
- Investigators
- Petra Schweinhardt, MD, PhD, Principal investigator, Department of Chiropractic Medicine, Balgrist University Hospital, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031286
- Sponsor's protocol ID
- NWR
- Status last verified
- Apr 2023
- First submitted
- 11 Aug 2021
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38231588
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Sensitization Between Men and Women After Cutaneous Thermal Stimuli
- ClinicalTrials.gov ID
- NCT05031286
- Acronym / sponsor ID
- NWR
- Conditions
- Central Sensitisation
- Keywords
- central sensitisation, central sensitization, nociception, withdrawal reflex, heat pain, secondary hyperalgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Other: Cutaneous thermal stimuli |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- good general health
- able to give informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cutaneous thermal stimuliApplication of thermal stimuli of different intensities to the skin | Other | Experimental Arm |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Derived from this study: PubMed 38231588Guekos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Schweinhardt, MD, PhD principal investigator
Department of Chiropractic Medicine, Balgrist University Hospital, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutaneous thermal stimuli in people with Central Sensitisation, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05031286, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.