Hyperalgesia, SecondaryNCT03966508
Reliability of Measuring the Area and Intensity of Secondary Hyperalgesia Induced by High Frequency Stimulation
A study testing High-frequency electrical stimulation in people with Hyperalgesia, Secondary, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study is designed to evaluate the method of assessing the and intensity areas of secondary hyperalgesia induced by High Frequency Stimulation (HFS). Measures of the areas of secondary hyperalgesia will take place on two experimental days separated by a minimum of two weeks. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperalgesia, Secondary
- What is being tested?
- High-frequency electrical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Apr 2019to 31 Aug 2019
- 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
- Male or female sex
- age>18 years and <40 years
- be fluent either in English or French
- ability to provide informed consent
Who cannot join
- experiencing a pre-existing pain condition
- self-reported medication (except contraceptives) consumption within 48 hours before experimental day and/or self-reported recreational drug use
- presenting any medical conditions, including heart, neurological, dermatological and psychiatric diseases
- participation to more than 6 hours per week of sport
- exhibiting sign of damage at or near the ventral forearm
- tattoos on the tested forearm
- Failure to cooperate to the tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Test-retest Reliability of Measuring the Area and Intensity of Secondary Hyperalgesia Induced by High Frequency Stimulation of Skin Nociceptors
This study is designed to evaluate the method of assessing the and intensity areas of secondary hyperalgesia induced by High Frequency Stimulation (HFS). Measures of the areas of secondary hyperalgesia will take place on two experimental days separated by a minimum of two weeks. Each experimental day, the areas of secondary hyperalgesia will be assessed three times, starting 30 minutes following HFS. Furthermore, the investigators will assess if anxiety, catastrophization, stress and demographic variables modulate the extend of hyperalgesia.
Read the detailed description
This prospective cohort study is designed to evaluate the method of assessing the areas and intensity of secondary hyperalgesia following High Frequency Stimulation (HFS), and will consist of two experimental days separated by a minimum of two weeks. During the two each session (Day1 and Day2), subjects will go through the HFS procedure on the same forearm. Then, after a 30 minutes break, the area and intensity of secondary hyperalgesia induced by HFS will be assessed three times (Time9-14), with a two-minute break between each assessment.
Before the experiment, subjects will fill two questionnaires by email : the Spielberger Trait anxiety inventory and the Pain catastrophization scale.The first experimental day, the patients will be seated on a chair and informed consent will be gained. Subjects will provide demographic information to the researcher (age, gender, size) (Time1). Then, the forearm skin of the selected arm will be marked with a pen to improve the precision of subsequent measures. The subject will then observe a period of rest for 5 minutes, to provide a baseline measure of heart rate variability.
Next, the patients will be asked to rate the pain induced by pin-prick stimulation in the area surrounding the electrode (Time2).
Following standardized explanation of the HFS procedure, the subject will fill the Spielberger State anxiety inventory (Time5), and HFS will be applied on the volar forearm (6-10 cm distal to the cubital fossa) (Time6). To avoid any confounding effect of handedness, the arm onto which HFS will be applied (dominant vs nondominant) will be counterbalanced across participants. In summary, HFS will consist of 12 trains of 42 Hz electrical pulses (pulse width: 2 ms) lasting 1 s each. The time interval between each train will 10 s. The intensity of stimulation will be 5mA. Heart rate variability during the HFS procedure will be monitored.
After a 25 minutes break the heart rate variability will be assessed a third time during 5 minutes. During the break, subjects will be asked to stay seated, to fill the Pain Catastrophizing scale (short-version) and give a rating from 0-100 for the pain and stress experienced during the HFS procedure (Time7).
Following this break, the area of secondary hyperalgesia will be assessed with a calibrated 128 mN pinprick probe (The Pin Prick, MRC Systems GmbH, Heidelger, Germany) (Time9). Pokes of 1-second duration will be provided at a frequency of 0.5 Hz, starting well outside and approaching the stimulation site with steps of 0,5 cm from 4 different directions towards the application site. Participants will be asked to keep their eyes closed during the entire mapping procedure. Then, participants will rate the pain induced by pin-prick stimulation in the area surrounding the electrode (Time10). This procedure will be conducted three times, with a two-minute break between each assessment (Time 11-14).
The second experimental day (Day2), the procedure will be similar to the first, but informed consent and the Spielberger Trait anxiety inventory and the Pain catastrophization scale will not be filled.
- Conditions
- Hyperalgesia, Secondary
- Being tested
- High-frequency electrical stimulation
- Keywords
- central sensitization, High-frequency electrical stimulation
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency electrical stimulationProcedure or surgery
High-frequency stimulation will be applied on the volar forearm (6-10 cm distal to the cubital fossa). To avoid any confounding effect of handedness, the arm onto which HFS will be applied twice (dominant vs nondominant) will be counterbalanced across participants. HFS will consist of 12 trains of 42 Hz electrical pulses lasting 1 s each. The time interval between each train will be 10 s. The intensity of stimulation will be 5mA. Electrical pulses will be delivered to the skin using a specifically-designed electrode designed: the cathode consists of 16 blunt stainless-steel pins with a diameter of 0.2 mm protruding 1 mm from the base. The 16 pins are placed in a circle with a diameter of 10 mm. The anode consists of a surrounding stainless-steel ring having an inner diameter of 22 mm and an outer diameter of 40 mm. This procedure induces secondary pinprick hyperalgesia (an increase in pinprick sensitivity in a large area of the skin).
| Study group | Role | What they receive |
|---|---|---|
| hyperalgesia measurement | Experimental | Not described Receives: Procedure: High-frequency electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area of secondary hyperalgesia
the area of secondary hyperalgesia (cm square) will be assessed with a calibrated 128 mN pinprick probe (The Pin Prick, MRC Systems GmbH, Heidelger, Germany). Pokes of 1-second duration will be provided at a frequency of 0.5 Hz, starting well outside and approaching the stimulation site with steps of 0,5 cm from 4 different directions towards the application site. Participants will be asked to keep their eyes closed during the entire mapping procedure.
Measured: 30 minutes (Time9), 35 minutes (Time11) and 40 minutes (Time13) after the application of HFS. There will be two HFS session (Day1 and Day2) separated by at least 15 days. Outcomes are taken at Day1 at Time9, 11 & 13 and on Day 2 at Time9, 11 & 13
Pin-prick pain in the area of secondary hyperalgesia
participants will rate the pain induced by pin-prick stimulation in the area surrounding the electrode on a numerical rating scale ranging from 0 (no perception) to 100 (maximal pain), with 50 representing the transition from nonpainful to painful domains of sensation
Measured: 5 minutes before (Time2), 33 minutes (Time10), 40 minutes (Time12) and 43 minutes (Time14) after the application of HFS. Outcomes are taken at Day1 at Time2, 10, 12 & 14 and on Day 2 at Time2, 10, 12 & 14
Secondary outcomes (11)
Spielberger State Anxiety inventory (total score)
questionnaire assessing the state of anxiety. The score will range from 20 (low state anxiety) to 80 (high state anxiety).
Measured: Just before the application of HFS (time 5). Outcome is taken at Day 1 at Time5 and on Day 2 at Time5.
Spielberger Trait Anxiety inventory (total score)
questionnaire assessing the trait of anxiety. The score will range from 20 (low trait anxiety) to 80 (high trait anxiety). This questionnaire will be sent by email to the participant.
Measured: On day 0, one day before the first testing session (Day 1)
Pain Catastrophization Scale (total score)
questionnaire to assess thoughts and emotions in response to pain. The score will range from 0 (low catastrophization) to 52 (high catastrophization).
Measured: On day 0, one day before the first testing session (Day 1)
Pain catastrophization scale modified version
questionnaire to assess thoughts and emotions in response to a specific painful event. The score will range from 0 (low catastrophization) to 24 (high catastrophization).
Measured: Just after the application of HFS (time 7). Outcome is taken at Day 1 at Time7 and on Day 2 at Time7.
Stress assessment using a Visual Analog Stress scale
Stress on a scale from 0 (low stress) to 100 (maximal stress).
Measured: Just after the application of HFS (time 7). Outcome is taken at Day 1 at Time 7 and on Day 2 at Time 7.
Detection threshold to a single electrical pulse (in mA)
Lowest intensity at which the participant feels the electrical pulse
Measured: 2 minutes before the application of HFS (Time3). Outcomes are taken at Day1 at Time2 on Day2 at Time2
Age
Self-declared age of the subject
Measured: 10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
Size
Self-declared size of the subject
Measured: 10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
Gender
Self-declared gender of the subject
Measured: 10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
Weight
Self-declared weight of the subject
Measured: 10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
Heart rate variability
changes in the time interval between heart beats through the study completion.
Measured: Continuous assessment from Time1 (10 minutes before the application of HFS) to Time15 (45 minutes after the application of HFS) during each session. Outcome is taken from Time1-Time15 during each of the two testing sessions (Day1 and at Day2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start15 Apr 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperalgesia, SecondaryStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966508
- Sponsor's protocol ID
- HFS reliability
- Status last verified
- Apr 2019
- First submitted
- 30 Apr 2019
- Last updated
- 19 Nov 2019
- 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 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-retest Reliability of Measuring the Area and Intensity of Secondary Hyperalgesia Induced by High Frequency Stimulation of Skin Nociceptors
- ClinicalTrials.gov ID
- NCT03966508
- Acronym / sponsor ID
- HFS reliability
- Conditions
- Hyperalgesia, Secondary
- Keywords
- central sensitization, High-frequency electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 29 May 2019 (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 study is designed to evaluate the method of assessing the and intensity areas of secondary hyperalgesia induced by High Frequency Stimulation (HFS). Measures of the areas of secondary hyperalgesia will take place on two experimental days separated by a minimum of two weeks. Each experimental day, the areas of secondary hyperalgesia will be assessed three times, starting 30 minutes following HFS. Furthermore, the investigators will assess if anxiety, catastrophization, stress and demographic variables modulate the extend of hyperalgesia.
Detailed description
This prospective cohort study is designed to evaluate the method of assessing the areas and intensity of secondary hyperalgesia following High Frequency Stimulation (HFS), and will consist of two experimental days separated by a minimum of two weeks. During the two each session (Day1 and Day2), subjects will go through the HFS procedure on the same forearm. Then, after a 30 minutes break, the area and intensity of secondary hyperalgesia induced by HFS will be assessed three times (Time9-14), with a two-minute break between each assessment.
Before the experiment, subjects will fill two questionnaires by email : the Spielberger Trait anxiety inventory and the Pain catastrophization scale.The first experimental day, the patients will be seated on a chair and informed consent will be gained. Subjects will provide demographic information to the researcher (age, gender, size) (Time1). Then, the forearm skin of the selected arm will be marked with a pen to improve the precision of subsequent measures. The subject will then observe a period of rest for 5 minutes, to provide a baseline measure of heart rate variability.
Next, the patients will be asked to rate the pain induced by pin-prick stimulation in the area surrounding the electrode (Time2).
Following standardized explanation of the HFS procedure, the subject will fill the Spielberger State anxiety inventory (Time5), and HFS will be applied on the volar forearm (6-10 cm distal to the cubital fossa) (Time6). To avoid any confounding effect of handedness, the arm onto which HFS will be applied (dominant vs nondominant) will be counterbalanced across participants. In summary, HFS will consist of 12 trains of 42 Hz electrical pulses (pulse width: 2 ms) lasting 1 s each. The time interval between each train will 10 s. The intensity of stimulation will be 5mA. Heart rate variability during the HFS procedure will be monitored.
After a 25 minutes break the heart rate variability will be assessed a third time during 5 minutes. During the break, subjects will be asked to stay seated, to fill the Pain Catastrophizing scale (short-version) and give a rating from 0-100 for the pain and stress experienced during the HFS procedure (Time7).
Following this break, the area of secondary hyperalgesia will be assessed with a calibrated 128 mN pinprick probe (The Pin Prick, MRC Systems GmbH, Heidelger, Germany) (Time9). Pokes of 1-second duration will be provided at a frequency of 0.5 Hz, starting well outside and approaching the stimulation site with steps of 0,5 cm from 4 different directions towards the application site. Participants will be asked to keep their eyes closed during the entire mapping procedure. Then, participants will rate the pain induced by pin-prick stimulation in the area surrounding the electrode (Time10). This procedure will be conducted three times, with a two-minute break between each assessment (Time 11-14).
The second experimental day (Day2), the procedure will be similar to the first, but informed consent and the Spielberger Trait anxiety inventory and the Pain catastrophization scale will not be filled.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hyperalgesia measurement | Experimental | Procedure: High-frequency electrical stimulation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female sex
- age>18 years and <40 years
- be fluent either in English or French
- ability to provide informed consent
Key exclusion criteria (7 listed)
- experiencing a pre-existing pain condition
- self-reported medication (except contraceptives) consumption within 48 hours before experimental day and/or self-reported recreational drug use
- presenting any medical conditions, including heart, neurological, dermatological and psychiatric diseases
- participation to more than 6 hours per week of sport
- exhibiting sign of damage at or near the ventral forearm
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 |
|---|---|---|
| High-frequency electrical stimulationHigh-frequency stimulation will be applied on the volar forearm (6-10 cm distal to the cubital fossa). To avoid any confounding effect of handedness, the arm onto which HFS will be applied twice (dominant vs nondominant) will be counterbalanced across participants. HFS will consist of 12 trains of 42 Hz electrical pulses lasting 1 s each. The time interval between each train will be 10 s. The intensity of stimulation will be 5mA. Electrical pulses will be delivered to the skin using a specifically-designed electrode designed: the cathode consists of 16 blunt stainless-steel pins with a diameter of 0.2 mm protruding 1 mm from the base. The 16 pins are placed in a circle with a diameter of 10 mm. The anode consists of a surrounding stainless-steel ring having an inner diameter of 22 mm and an outer diameter of 40 mm. This procedure induces secondary pinprick hyperalgesia (an increase in pinprick sensitivity in a large area of the skin). | Procedure or surgery | hyperalgesia measurement |
Primary outcome
The area of secondary hyperalgesia
Time frame: 30 minutes (Time9), 35 minutes (Time11) and 40 minutes (Time13) after the application of HFS. There will be two HFS session (Day1 and Day2) separated by at least 15 days. Outcomes are taken at Day1 at Time9, 11 & 13 and on Day 2 at Time9, 11 & 13
the area of secondary hyperalgesia (cm square) will be assessed with a calibrated 128 mN pinprick probe (The Pin Prick, MRC Systems GmbH, Heidelger, Germany). Pokes of 1-second duration will be provided at a frequency of 0.5 Hz, starting well outside and approaching the stimulation site with steps of 0,5 cm from 4 different directions towards the application site. Participants will be asked to keep their eyes closed during the entire mapping procedure.
Pin-prick pain in the area of secondary hyperalgesia
Time frame: 5 minutes before (Time2), 33 minutes (Time10), 40 minutes (Time12) and 43 minutes (Time14) after the application of HFS. Outcomes are taken at Day1 at Time2, 10, 12 & 14 and on Day 2 at Time2, 10, 12 & 14
participants will rate the pain induced by pin-prick stimulation in the area surrounding the electrode on a numerical rating scale ranging from 0 (no perception) to 100 (maximal pain), with 50 representing the transition from nonpainful to painful domains of sensation
11 secondary outcomes
Spielberger State Anxiety inventory (total score)
Time frame: Just before the application of HFS (time 5). Outcome is taken at Day 1 at Time5 and on Day 2 at Time5.
Spielberger Trait Anxiety inventory (total score)
Time frame: On day 0, one day before the first testing session (Day 1)
Pain Catastrophization Scale (total score)
Time frame: On day 0, one day before the first testing session (Day 1)
Pain catastrophization scale modified version
Time frame: Just after the application of HFS (time 7). Outcome is taken at Day 1 at Time7 and on Day 2 at Time7.
Stress assessment using a Visual Analog Stress scale
Time frame: Just after the application of HFS (time 7). Outcome is taken at Day 1 at Time 7 and on Day 2 at Time 7.
Detection threshold to a single electrical pulse (in mA)
Time frame: 2 minutes before the application of HFS (Time3). Outcomes are taken at Day1 at Time2 on Day2 at Time2
Age
Time frame: 10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
Size
Time frame: 10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
Gender
Time frame: 10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
Weight
Time frame: 10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
Heart rate variability
Time frame: Continuous assessment from Time1 (10 minutes before the application of HFS) to Time15 (45 minutes after the application of HFS) during each session. Outcome is taken from Time1-Time15 during each of the two testing sessions (Day1 and at Day2)
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 19 Nov 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency electrical stimulation in people with Hyperalgesia, Secondary, run by Université Catholique de Louvain at 1 site in Belgium.
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 4 inclusion and 7 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 19 Nov 2019. 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 Belgium. 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?
The area of secondary hyperalgesia (time frame: 30 minutes (Time9), 35 minutes (Time11) and 40 minutes (Time13) after the application of HFS. There will be two HFS session (Day1 and Day2) separated by at least 15 days. Outcomes are taken at Day1 at Time9, 11 & 13 and on Day 2 at Time9, 11 & 13). 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?
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 19 Nov 2019.