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Reliability of Measuring the Area and Intensity of Secondary Hyperalgesia Induced by High Frequency Stimulation

Primary Purpose

Hyperalgesia, Secondary

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
High-frequency electrical stimulation
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperalgesia, Secondary focused on measuring central sensitization, High-frequency electrical stimulation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLouvain

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hyperalgesia measurement

Arm Description

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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).
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.
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).
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).
Stress assessment using a Visual Analog Stress scale
Stress on a scale from 0 (low stress) to 100 (maximal stress).
Detection threshold to a single electrical pulse (in mA)
Lowest intensity at which the participant feels the electrical pulse
Age
Self-declared age of the subject
Size
Self-declared size of the subject
Gender
Self-declared gender of the subject
Weight
Self-declared weight of the subject
Heart rate variability
changes in the time interval between heart beats through the study completion.

Full Information

First Posted
April 30, 2019
Last Updated
November 18, 2019
Sponsor
Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03966508
Brief Title
Reliability of Measuring the Area and Intensity of Secondary Hyperalgesia Induced by High Frequency Stimulation
Official Title
Test-retest Reliability of Measuring the Area and Intensity of Secondary Hyperalgesia Induced by High Frequency Stimulation of Skin Nociceptors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia, Secondary
Keywords
central sensitization, High-frequency electrical stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hyperalgesia measurement
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
High-frequency electrical stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
The area of secondary hyperalgesia
Description
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.
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
Title
Pin-prick pain in the area of secondary hyperalgesia
Description
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
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
Secondary Outcome Measure Information:
Title
Spielberger State Anxiety inventory (total score)
Description
questionnaire assessing the state of anxiety. The score will range from 20 (low state anxiety) to 80 (high state anxiety).
Time Frame
Just before the application of HFS (time 5). Outcome is taken at Day 1 at Time5 and on Day 2 at Time5.
Title
Spielberger Trait Anxiety inventory (total score)
Description
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.
Time Frame
On day 0, one day before the first testing session (Day 1)
Title
Pain Catastrophization Scale (total score)
Description
questionnaire to assess thoughts and emotions in response to pain. The score will range from 0 (low catastrophization) to 52 (high catastrophization).
Time Frame
On day 0, one day before the first testing session (Day 1)
Title
Pain catastrophization scale modified version
Description
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).
Time Frame
Just after the application of HFS (time 7). Outcome is taken at Day 1 at Time7 and on Day 2 at Time7.
Title
Stress assessment using a Visual Analog Stress scale
Description
Stress on a scale from 0 (low stress) to 100 (maximal stress).
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.
Title
Detection threshold to a single electrical pulse (in mA)
Description
Lowest intensity at which the participant feels the electrical pulse
Time Frame
2 minutes before the application of HFS (Time3). Outcomes are taken at Day1 at Time2 on Day2 at Time2
Title
Age
Description
Self-declared age of the subject
Time Frame
10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
Title
Size
Description
Self-declared size of the subject
Time Frame
10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
Title
Gender
Description
Self-declared gender of the subject
Time Frame
10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
Title
Weight
Description
Self-declared weight of the subject
Time Frame
10 minutes before the application of HFS (Time1). Outcomes are taken at Day1 at Time1 on Day2 at Time1
Title
Heart rate variability
Description
changes in the time interval between heart beats through the study completion.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
UCLouvain
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Reliability of Measuring the Area and Intensity of Secondary Hyperalgesia Induced by High Frequency Stimulation

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