- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03966508
Reliability of Measuring the Area and Intensity of Secondary Hyperalgesia Induced by High Frequency Stimulation
Test-retest Reliability of Measuring the Area and Intensity of Secondary Hyperalgesia Induced by High Frequency Stimulation of Skin Nociceptors
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brussels, Belgium, 1200
- UCLouvain
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female sex
- age>18 years and <40 years
- be fluent either in English or French
- ability to provide informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: hyperalgesia measurement
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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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
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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
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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
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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questionnaire assessing the state of anxiety.
The score will range from 20 (low state anxiety) to 80 (high state anxiety).
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Just before the application of HFS (time 5). Outcome is taken at Day 1 at Time5 and on Day 2 at Time5.
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Spielberger Trait Anxiety inventory (total score)
Time Frame: On day 0, one day before the first testing session (Day 1)
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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.
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On day 0, one day before the first testing session (Day 1)
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Pain Catastrophization Scale (total score)
Time Frame: On day 0, one day before the first testing session (Day 1)
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questionnaire to assess thoughts and emotions in response to pain.
The score will range from 0 (low catastrophization) to 52 (high catastrophization).
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On day 0, one day before the first testing session (Day 1)
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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.
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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).
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Just after the application of HFS (time 7). Outcome is taken at Day 1 at Time7 and on Day 2 at Time7.
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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.
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Stress on a scale from 0 (low stress) to 100 (maximal stress).
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Just after the application of HFS (time 7). Outcome is taken at Day 1 at Time 7 and on Day 2 at Time 7.
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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
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Lowest intensity at which the participant feels the electrical pulse
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2 minutes before the application of HFS (Time3). Outcomes are taken at Day1 at Time2 on Day2 at Time2
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Age
Time Frame: 10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
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Self-declared age of the subject
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10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
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Size
Time Frame: 10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
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Self-declared size of the subject
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10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
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Gender
Time Frame: 10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
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Self-declared gender of the subject
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10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
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Weight
Time Frame: 10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
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Self-declared weight of the subject
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10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
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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)
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changes in the time interval between heart beats through the study completion.
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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)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HFS reliability
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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