PainColdNCT05192577
Testing Protocol for Cold-sensing Fibers
A study testing Electrical stimulation in people with Pain, run by Aalborg University at 1 site in Denmark.
Trial summary
This project aims to evaluate whether electrical stimulation can modulate the cold detection threshold and the cold pain threshold. The hypothesis is that different electrical stimulation will either decrease or increase the cold threshold depending on the shape of the electrical stimulus. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Nov 2021to 3 Jul 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women
- 18-80 years
- Speak and understand English
Who cannot join
- Pregnancy or breast feeding
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous and present neurologic, musculoskeletal or mental illnesses (e.g., epilepsy, neuropathy, fibromyalgia and depression)
- Skin diseases
- Past history of conditions possibly leading to neuropathy
- Inability to cooperate
Show all 11Show fewer
- Current use of medications that may affect the study, e.g., analgesics
- Previous traumatic experience of an electrical accident
- Consumption of alcohol or painkillers within the last 24 hours
- Participation in other pain studies throughout the study period
- Patients with cardiac diseases (e.g., pacemaker).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nerve Excitability Testing Protocol for Cold-sensing Fibers
This project aims to evaluate whether electrical stimulation can modulate the cold detection threshold and the cold pain threshold. The hypothesis is that different electrical stimulation will either decrease or increase the cold threshold depending on the shape of the electrical stimulus. If a combination of electrical stimuli and cold stimuli could be used, this could lead to a novel method for estimating the excitability properties of cold-sensing fibers. The sub-project takes place in 1 session (1.5 hours).
- Conditions
- Pain
- Being tested
- Electrical stimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulationOther
At the beginning of the session, an electrode will be attached to the participant's ankle. Electrical stimulation will be applied to estimate the electrical perception threshold. This threshold will be used as condition stimuli when different thermal thresholds are assessed.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Other: Electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold detection threshold
The cold detection threshold will be estimated by reducing the temperature until the subjects perceive a cold sensation.
Measured: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Cold detection threshold with conditioning electrical stimuli
The cold detection threshold will be estimated by reducing the temperature until the subjects perceive a cold sensation. Simultaneous will electrical stimulation be applied.
Measured: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Warm detection threshold
The warm detection threshold will be estimated by increasing the temperature until the subjects perceive a warm sensation.
Measured: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Warm detection threshold with conditioning electrical stimuli
The warm detection threshold will be estimated by increasing the temperature until the subjects perceive a warm sensation. Simultaneous will electrical stimulation be applied.
Measured: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Warm pain threshold
The warm pain threshold will be estimated by increasing the temperature until the subjects perceive a painful warm sensation.
Measured: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Warm pain threshold with conditioning electrical stimuli
The warm pain threshold will be estimated by increasing the temperature until the subjects perceive a warm painful sensation. Simultaneous will electrical stimulation be applied.
Measured: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Cold pain threshold
The cold pain threshold will be estimated by reducing the temperature until the subjects perceive a painful warm sensation.
Measured: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Cold pain threshold with conditioning electrical stimuli
The cold pain threshold will be estimated by reducing the temperature until the subjects perceive a cold painful sensation. Simultaneous will electrical stimulation be applied.
Measured: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
The sensation of pulse 1
The investigator will ask the participant to rate the sensation by a questionnaire. The scale will be 0-10, where 0 indicates no sensation and 10 is the worst imaginable sensation.
Measured: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
The sensation of pulse 2
The investigater will ask the participant to rate the sensation by a questionnaire. The scale will be from 0-10 where 0 indication no sensation and 10 the worst imaginable sensation.
Measured: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Perception threshold
The Perception threshold for the cutaneous electrical stimulation will be estimated for two different pulse shapes of the electrical stimulus. The perception threshold is defined as the electrical current needed for the participant to perceive the stimulus. The perception threshold will be estimated by the method of limits.
Measured: During session 1. The estimation of the outcome measurement take approximately 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start24 Nov 2021
- Primary completion30 Jan 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Tigerholm, Aalborg University
- Investigators
- Jenny Tigerholm, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192577
- Sponsor's protocol ID
- N-20200014 5-subproject
- Acronym
- Cold
- Status last verified
- Aug 2023
- First submitted
- 23 Nov 2021
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Excitability Testing Protocol for Cold-sensing Fibers
- ClinicalTrials.gov ID
- NCT05192577
- Acronym / sponsor ID
- Cold / N-20200014 5-subproject
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 14 Jan 2022 (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.
This project aims to evaluate whether electrical stimulation can modulate the cold detection threshold and the cold pain threshold. The hypothesis is that different electrical stimulation will either decrease or increase the cold threshold depending on the shape of the electrical stimulus. If a combination of electrical stimuli and cold stimuli could be used, this could lead to a novel method for estimating the excitability properties of cold-sensing fibers. The sub-project takes place in 1 session (1.5 hours).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Electrical stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy men and women
- 18-80 years
- Speak and understand English
Key exclusion criteria (11 listed)
- Pregnancy or breast feeding
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous and present neurologic, musculoskeletal or mental illnesses (e.g., epilepsy, neuropathy, fibromyalgia and depression)
- Skin diseases
- Past history of conditions possibly leading to neuropathy
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 |
|---|---|---|
| Electrical stimulationAt the beginning of the session, an electrode will be attached to the participant's ankle. Electrical stimulation will be applied to estimate the electrical perception threshold. This threshold will be used as condition stimuli when different thermal thresholds are assessed. | Other | Study group |
Primary outcome
Cold detection threshold
Time frame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
The cold detection threshold will be estimated by reducing the temperature until the subjects perceive a cold sensation.
Cold detection threshold with conditioning electrical stimuli
Time frame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
The cold detection threshold will be estimated by reducing the temperature until the subjects perceive a cold sensation. Simultaneous will electrical stimulation be applied.
Warm detection threshold
Time frame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
The warm detection threshold will be estimated by increasing the temperature until the subjects perceive a warm sensation.
Warm detection threshold with conditioning electrical stimuli
Time frame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
The warm detection threshold will be estimated by increasing the temperature until the subjects perceive a warm sensation. Simultaneous will electrical stimulation be applied.
Warm pain threshold
Time frame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
The warm pain threshold will be estimated by increasing the temperature until the subjects perceive a painful warm sensation.
Warm pain threshold with conditioning electrical stimuli
Time frame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
The warm pain threshold will be estimated by increasing the temperature until the subjects perceive a warm painful sensation. Simultaneous will electrical stimulation be applied.
Cold pain threshold
Time frame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
The cold pain threshold will be estimated by reducing the temperature until the subjects perceive a painful warm sensation.
Cold pain threshold with conditioning electrical stimuli
Time frame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
The cold pain threshold will be estimated by reducing the temperature until the subjects perceive a cold painful sensation. Simultaneous will electrical stimulation be applied.
The sensation of pulse 1
Time frame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
The investigator will ask the participant to rate the sensation by a questionnaire. The scale will be 0-10, where 0 indicates no sensation and 10 is the worst imaginable sensation.
The sensation of pulse 2
Time frame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
The investigater will ask the participant to rate the sensation by a questionnaire. The scale will be from 0-10 where 0 indication no sensation and 10 the worst imaginable sensation.
Perception threshold
Time frame: During session 1. The estimation of the outcome measurement take approximately 15 minutes.
The Perception threshold for the cutaneous electrical stimulation will be estimated for two different pulse shapes of the electrical stimulus. The perception threshold is defined as the electrical current needed for the participant to perceive the stimulus. The perception threshold will be estimated by the method of limits.
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 2 Aug 2023.
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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.
Jenny Tigerholm principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation in people with Pain, run by Aalborg University at 1 site in Denmark.
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 3 inclusion and 11 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 2 Aug 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 Denmark. 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?
Cold detection threshold (time frame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2023; AzTrials last refreshed its copy on 27 Oct 2026.