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

NCT03966508 | Completed

• 1 other identifier: HFS reliability
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperalgesia, Secondary

Keywords

central sensitization; High-frequency electrical stimulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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)

  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)

  On day 0, one day before the first testing session (Day 1)

• Pain Catastrophization Scale (total score)

  On day 0, one day before the first testing session (Day 1)

• Pain catastrophization scale modified version

  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

  Just after the application of HFS (time 7). Outcome is taken at Day 1 at Time 7 and on Day 2 at Time 7.

Study Arms (1)

hyperalgesia measurement

EXPERIMENTAL

Procedure: High-frequency electrical stimulation

Interventions

High-frequency electrical stimulation PROCEDURE

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).

hyperalgesia measurement

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female sex
• age\>18 years and \<40 years
• be fluent either in English or French
• ability to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

UCLouvain

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Hyperalgesia

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 29, 2019
• Study Start: April 15, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)