Neuropathy;PeripheralNCT04865185
Effect of Topical Lidocaine on Warm and Cold Sensation in Healthy Individuals
A study testing Xylocaine spray 100mg/ml and Ethanol in people with Neuropathy;Peripheral and Thermal Hypesthesia, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of the present study is to systematically test the occurrence of paradoxical and illusory responses to cold and warm stimuli in healthy volunteers with artificial sensory loss. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathy;Peripheral, Thermal Hypesthesia
- What is being tested?
- Xylocaine spray 100mg/ml and Ethanol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 28 Feb 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
- Healthy subjects
- Age between 18 and 40 years
- Participant is able and willing to give informed consent.
Who cannot join
- Unable to understand and speak Danish
- Non-cooperative
- Chronic pain or acute pain the past week lasting more than 4 hours or pain on the day of investigation
- Pain medication within the last week
- Medication within the last week that can affect assessment
- Psychiatric or neurological disease and diseases that may affect the assessment
Show all 14Show fewer
- Sensory disturbances
- History or symptoms of significant diseases (e.g. psychiatric or neurological disease, diseases that may affect the assessment, sensory disturbances, cancer, diabetes mellitus, liver diseases, kidney diseases, cardiovascular diseases)
- Pregnancy or lactation
- Jetlag or sleep deprivation
- Alcohol or drug abuse
- Consumption of cannabis the last 4 weeks and consumption of alcohol in the last 48 hours
- Any abnormality of the skin or of vascular origin at application site
- History of hypersensitivity to lidocaine, other amide-type anesthetics, or other contents of the lidocaine or vehicle
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish Pain Research Center, Aarhus University, Aarhus University Hospital
Aarhus N, 8200
Ellen L Schaldemose, 93501942, ells@clin.au.dk
About this study
Official title: Effect of Topical Lidocaine on Warm and Cold Sensation in Healthy Individuals - a Randomized Crossover Trial
The purpose of the present study is to systematically test the occurrence of paradoxical and illusory responses to cold and warm stimuli in healthy volunteers with artificial sensory loss.
Read the detailed description
Efficient thermal sensation is important for adequate behavioral response to cold or warm stimuli and early signs of neuropathy can be changes in the thermal sensation.
Alterations in thermal perception can results in paradoxical heat sensation (a warm perception when the skin is cooled) or a peculiar/burning sensation when the skin is stiumlated with simultaneous warm and cold (a "thermal grill").
Clarifying the occurrence of these paradoxical and illusory sensations, may help understanding early signs of peripheral neuropathy as well as thermal sensory perception.
The investigators plan to conduct a study on thermal sensory perception using a model of sensory loss in healthy volunteers and systematically test the occurrence of paradoxical heat sensations and responses to the thermal grill.
- Conditions
- Neuropathy;Peripheral, Thermal Hypesthesia
- Being tested
- Xylocaine spray 100mg/ml, Ethanol
- Keywords
- Paradoxical Heat Sensations, Thermal Grill Illusion, Lidocaine
- Medical subject headings
- Neuritis, Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylocaine spray 100mg/mlDiagnostic test
Topical application
EthanolDiagnostic test
Topical application
| Study group | Role | What they receive |
|---|---|---|
| Xylocaine spray 100mg/ml | Active comparator | Topical application Receives: Diagnostic Test: Xylocaine spray 100mg/ml |
| Ethanol | Placebo comparator | Topical application Receives: Diagnostic Test: Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paradoxical heat sensation (PHS)
Number of PHS responders on arm treated with lidocaine 45 minutes after drug application and Number of PHS responders on arm treated with ethanol 45 minutes after drug application
Measured: 45 minutes
Secondary outcomes (8)
Thermal Grill (TG)
Number of TG responders on arm treated with lidocaine 75 minutes after drug application and Number of TG responders on arm treated with ethanol 75 minutes after drug application
Measured: 75 minutes
Quality of the Thermal Grill (TG)
The participants are asked whether the stimulus is burning, hot, warm, neutral, cold, or freezing cold after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 75 minutes after drug application The participants are asked whether the stimulus is burning, hot, warm, neutral, cold, or freezing cold after the TG-condition (warm and cold) or only warm or only cold on arm treated with ethanol 75 minutes after drug application
Measured: 75 minutes
Pain intensity of the Thermal Grill (TG)
The participants are asked to rate the intensity of pain on a visual analog scale (VAS) 0-100 (0 no pain; 100 worst pain imaginable) after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 90 minutes after drug application The participants are asked to rate the intensity of pain on a VAS 0-100 (0 no pain; 100 worst pain imaginable) after the TG-condition (warm and cold), only warm or only cold on arm treated with ethanol 90 minutes after drug application
Measured: 90 minutes
Intensity of unpleasantness of the Thermal Grill (TG)
The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no unpleasantness; 100 worst unpleasantness imaginable) after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 95 minutes after drug application The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no unpleasantness; 100 worst unpleasantness imaginable) after the TG-condition (warm and cold), only warm or only cold on arm treated with ethanol 95 minutes after drug application
Measured: 95 minutes
Intensity of cold of the Thermal Grill (TG)
The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no cold; 100 extremely cold ) after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 95 minutes after drug application
The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no cold; 100 extremely cold ) after the TG-condition (warm and cold), only warm or only cold on arm treated with ethanol 95 minutes after drug application
Measured: 95 minutes
Intensity of warm of the Thermal Grill (TG)
The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no warm; 100 extremely warm ) after the TG-condition (warm and cold), only warm or only cold on arm treated with lidocaine 95 minutes after drug application
The participants are asked to rate the intensity of unpleasantness on a VAS 0-100 (0 no warm; 100 extremely warm ) after the TG-condition (warm and cold), only warm or only cold on arm treated with ethanol 95 minutes after drug application
Measured: 95 minutes
Paradoxical heat sensation (PHS)
Number of PHS responders at baseline without any treatment, 30 minutes before drug application
Measured: 30 minutes before drug application
Thermal Grill (TG)
Number of TG responders at baseline without any treatment 20 minutes before drug application
Measured: 20 minutes before drug application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Mar 2021
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathy;PeripheralStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen L Schaldemose, MD, Principal investigator, Danish Pain Research Center, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865185
- Sponsor's protocol ID
- TLH21
- Status last verified
- Mar 2021
- First submitted
- 15 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Lidocaine on Warm and Cold Sensation in Healthy Individuals - a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT04865185
- Acronym / sponsor ID
- TLH21
- Conditions
- Neuropathy;Peripheral, Thermal Hypesthesia
- Keywords
- Paradoxical Heat Sensations, Thermal Grill Illusion, Lidocaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 29 Apr 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.
The purpose of the present study is to systematically test the occurrence of paradoxical and illusory responses to cold and warm stimuli in healthy volunteers with artificial sensory loss.
Detailed description
Efficient thermal sensation is important for adequate behavioral response to cold or warm stimuli and early signs of neuropathy can be changes in the thermal sensation.
Alterations in thermal perception can results in paradoxical heat sensation (a warm perception when the skin is cooled) or a peculiar/burning sensation when the skin is stiumlated with simultaneous warm and cold (a "thermal grill").
Clarifying the occurrence of these paradoxical and illusory sensations, may help understanding early signs of peripheral neuropathy as well as thermal sensory perception.
The investigators plan to conduct a study on thermal sensory perception using a model of sensory loss in healthy volunteers and systematically test the occurrence of paradoxical heat sensations and responses to the thermal grill.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylocaine spray 100mg/ml | Active comparator | Diagnostic Test: Xylocaine spray 100mg/mlTopical application |
| Ethanol | Placebo comparator | Diagnostic Test: EthanolTopical application |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects
- Age between 18 and 40 years
- Participant is able and willing to give informed consent.
Key exclusion criteria (14 listed)
- Unable to understand and speak Danish
- Non-cooperative
- Chronic pain or acute pain the past week lasting more than 4 hours or pain on the day of investigation
- Pain medication within the last week
- Medication within the last week that can affect assessment
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 |
|---|---|---|
| Xylocaine spray 100mg/mlTopical application | Diagnostic test | Xylocaine spray 100mg/ml |
| EthanolTopical application | Diagnostic test | Ethanol |
Primary outcome
Paradoxical heat sensation (PHS)
Time frame: 45 minutes
Number of PHS responders on arm treated with lidocaine 45 minutes after drug application and Number of PHS responders on arm treated with ethanol 45 minutes after drug application
8 secondary outcomes
Thermal Grill (TG)
Time frame: 75 minutes
Quality of the Thermal Grill (TG)
Time frame: 75 minutes
Pain intensity of the Thermal Grill (TG)
Time frame: 90 minutes
Intensity of unpleasantness of the Thermal Grill (TG)
Time frame: 95 minutes
Intensity of cold of the Thermal Grill (TG)
Time frame: 95 minutes
Intensity of warm of the Thermal Grill (TG)
Time frame: 95 minutes
Paradoxical heat sensation (PHS)
Time frame: 30 minutes before drug application
Thermal Grill (TG)
Time frame: 20 minutes before drug application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Neuropathy;Peripheral
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
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.
Ellen L Schaldemose, MD principal investigator
Danish Pain Research Center, Aarhus 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 Xylocaine spray 100mg/ml and Ethanol in people with Neuropathy;Peripheral and Thermal Hypesthesia, run by University of Aarhus 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 14 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: status not confirmed, as of the sponsor's last update on 29 Apr 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ellen L Schaldemose, MD (+45 93501942, ells@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paradoxical heat sensation (PHS) (time frame: 45 minutes). 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 29 Apr 2021.