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Adaptation of the Motor System to Experimental Pain (KinesioPoint)

Primary Purpose

Kinesiophobia, Pain, Acute

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Experimental pain
Sponsored by
Universite du Littoral Cote d'Opale
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kinesiophobia focused on measuring kinesiophobia, experimental pain, corticospinal excitability, motor control, CUSOM

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy subjects (who do not have self-reported neurological disorders)
  • Subjects who have signed an informed consent (who have a good command of French)
  • Subjects affiliated with or receiving social security benefits

Exclusion Criteria:

  • Psychiatric history obtained through physician questioning: individuals with mental retardation or severe impairment of cognitive, behavioral, or emotional function that precludes understanding the protocol and signing informed consent
  • Neurological history (epilepsy, stroke, surgeries performed on the brain or spinal cord, and history of neurological diseases affecting motor skills and sensation)
  • Subjects who are unable to receive informed information (dementia, hearing problems, poor French proficiency, etc.)
  • Contraindications to MST (epilepsy, intracranial metal foreign bodies, hearing aids or cochlear implants)
  • Taking psychotropic medications
  • Persons under guardianship or conservatorship
  • Pregnant and nursing women
  • Subjects with pacemakers

Sites / Locations

  • EurasportRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental pain

Arm Description

Experimental pain will be induced at the level of the dominant delto-pectoral groove of the participant (between the shoulder stump and the pectoral).

Outcomes

Primary Outcome Measures

Corticospinal excitability
It will be measured using transcranial magnetic stimulation at different intensities in order to model I/O curves for each participant. Measurements will be taken before (pain-free condition) and after (pain condition) the application of a patch of capsaicin 1%, at the shoulder. Electromyographic signals, induced by the magnetic stimuli, will be captured with surface electrodes glued to the skin the anterior deltoid and upper trapezius muscles. To facilitate obtaining deltoid MEPs, participants will be asked to voluntarily contract 8-12% of their maximum voluntary contraction. The Boltzmann sigmoidal function will be used to fit the data points to construct the I/O curves. The mathematical modeling of the I/O curves allows the calculation of three parameters: the slope, the plateau, and the S50, the intensity allowing to obtain a response twice less than the maximum response. These 3 parameters will be used to compare them with the 2 conditions (before and after pain).
Kinesiophobia
Kinesiophobia will be assessed using the French-Canadian version of the Tampa Kinesiophobia Questionnaire (EKT-CF). It takes the form of a self-reported questionnaire of 17 items using a Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with an acceptable degree of internal consistency (Cronbach's alpha = 0.71), satisfactory construct validity, and high sensitivity to change (intra-class correlation coefficient > 0.7). The total score is obtained by adding the value of the responses and is between 17 and 68. The value of 40/68 is considered as the threshold value at which kinesiophobia becomes significant.

Secondary Outcome Measures

Activation synergies
Surface electromyogram recordings of the anterior deltoid and upper trapezius muscles will be made on the dominant upper limb performing a pointing task and on which the experimental pain will be induced (pre-post measurements). The activation synergies will be recorded (relative durations between the onset of different surface EMG puffs of the targeted muscles).
Kinematic parameters: Linearity of motion
Trajectory length ratio (TLR), defined as the ratio of the total length of the trajectory traveled by the hand divided by the shortest length between the start and end points. A ratio of 1 indicates an ideal trajectory; as the ratio increases, the trajectory becomes less direct.
Kinematic parameters: Smoothness of motion
The number of velocity peaks on the kinematic path of the index. The higher this number, the less regular the motion.
Kinematic parameters: Maximum directional error
Maximum orthogonal distance between the hand position and the straight line connecting the start and end points.
EMG data and cumulative summation: The area of the puffs
The value of the area under the curves between the beginning and the end of the puffs.
EMG data and cumulative summation: CUSUMs
The value of the CUSUMs of each puff, which represents the small variations that may appear in surface EMG and may be masked by background fluctuations.

Full Information

First Posted
May 18, 2022
Last Updated
May 9, 2023
Sponsor
Universite du Littoral Cote d'Opale
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1. Study Identification

Unique Protocol Identification Number
NCT05396820
Brief Title
Adaptation of the Motor System to Experimental Pain
Acronym
KinesioPoint
Official Title
Adaptation of the Motor System to Experimental Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
April 8, 2023 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universite du Littoral Cote d'Opale

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 aims to measure the impact of an experimental pain on electromyography, kinematics of motion and motor cortical excitability.
Detailed Description
The main objective of this study will be to determine if the influence of pain on the corticospinal excitability of M1 (via the slopes of the I/O curves) is dependent on the level of kinesiophobia. The secondary objectives are firstly to measure the modifications induced by experimental pain on muscle activation synergies. Secondly, to measure the modifications induced by an experimental pain on the kinematics of the movement during a pointing task during the application of the pain. Finally, to determine if an experimental pain modifies the electrical activity of muscles located in the painful area during a pointing movement and the value of the cumulative sums (CUSUMs). Inclusion Criteria: Males and females of legal age. Healthy subjects (who do not have self-reported neurological disorders) Subjects who have signed an informed consent (who have a good command of French) Subjects who are affiliated with or benefit from a social security plan Criteria for non-inclusion: Psychiatric history obtained by physician questioning: individuals with mental retardation or severe impairment of cognitive, behavioral, or affective functions precluding understanding the protocol and signing informed consent Neurological history (epilepsy, stroke, surgeries performed on the brain or spinal cord, and history of neurological diseases affecting motor skills and sensation) Subjects who are unable to receive informed information (dementia, hearing problems, poor French proficiency, etc.) Contraindications to MST (epilepsy, intracranial metal foreign bodies, hearing aids or cochlear implants) Taking psychotropic medications Persons under guardianship or conservatorship Pregnant and nursing women Subjects with pacemakers Assessment before pain induction: ► Corticospinal excitability of M1: The TMS will be used to establish the input-output (I/O) curves. Stimuli of variable intensity between the threshold value (or MT for motor threshold) and the maximum will be delivered. In total, about ten stimulation intensities will be tested, and for each stimulation intensity, ten stimuli will be delivered, allowing then to calculate the average of the MEPs in order to draw the I/O curves of each participant. As recalled by national and international recommendations, TMS is a noninvasive and painless technique whose use in the scientific literature is extremely abundant. ► Pointing task: The participant will be seated on a chair facing a table so that his or her dominant forearm rests on the table. Markers will be placed at the table and chair legs as well as on the table, corresponding to the two support points of the elbow and the index finger, in order to standardize the starting position. The index finger should be positioned on the midline. The maximum amplitude of the pointing movement on the median line will be determined and then the target of the pointing movement will be placed at 80% of this maximum distance. The investigators chose a single target so that reaction time would not be impacted by too much cognitive load. The investigator will tell the participant to stand by, and then, within 4 to 10 seconds, an audible signal ("beep") will indicate to the subject that he/she should perform the pointing movement. Then the subject will return to the starting position at rest, and the procedure will repeat after a 4-10 second pause. For each evaluation session, 30 pointing movements reaching the target will be performed, the first three of which will not be counted (familiarization). The kinematic parameters of the pointing movements will be recorded using a 3D motion analysis video system. The markers will be placed on C7, and on the dominant side on the acromion, the olecranon, the dorsal aspect of the wrist and on the distal phalanx of the index finger. ► Muscle activation synergies: To measure muscle activations during this pointing task, surface EMG recording of the anterior deltoid and upper trapezius muscles will be performed on the dominant upper limb using a wireless collection system. Raw data of kinematic and EMG parameters will be stored and processed offline. Trials where the reaction time is less than 100ms will be excluded from the analysis. Assessment during experimental pain: ► Experimental Pain Induction: In this study, the application of a capsaicin 1% patch will be performed at the participant's dominant delto-pectoral groove (between the shoulder stump and pectoral) on intact, non-irritated, dry skin to generate experimental pain. For the purposes of this study, the investigators will remove this patch before the recommended application time (60 minutes) in order to generate a limited pain of 3 to 5/10 on a visual analog scale (VAS). ► Completion of the EKT-CF questionnaire: During the time of onset and stabilization of pain induced by the capsaicin 1% patch, the participant will be asked to complete the EKT-CF questionnaire in computerized form. An evaluation of the pain will be made at this time using a VAS and the value will be noted. ► TMS, Pointing and muscles activation: Once the pain has settled and stabilized, TMS, surface EMG and kinematic measurements will be performed again in the same way as described previously. The similar optimum stimulation point used for the TMS will be rigorously stimulated using the coordinates recorded previously. The duration of the experimental session is estimated at 2h30min, distributed as follows: Information, eligibility and consent collection: 15 minutes; preparation of the experiment (installation of the electrodes, setting of the devices: 45 minutes; recordings: 90 minutes).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kinesiophobia, Pain, Acute
Keywords
kinesiophobia, experimental pain, corticospinal excitability, motor control, CUSOM

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cross sectional study
Masking
None (Open Label)
Masking Description
A randomized number is allocated for all participants.
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental pain
Arm Type
Experimental
Arm Description
Experimental pain will be induced at the level of the dominant delto-pectoral groove of the participant (between the shoulder stump and the pectoral).
Intervention Type
Other
Intervention Name(s)
Experimental pain
Intervention Description
Experimental pain will be induced by capsaicin 1% on intact, non-irritated and dry shoulder's skin. For the purposes of this study, we will remove this patch before the recommended application time in order to generate a pain. The participant will be seated on a chair facing a table so that his or her dominant forearm rests on the table. Markers will be placed at the table and chair legs as well as on the table, corresponding to the two support points of the elbow and the index finger, in order to standardize the starting position. The target of the pointing movement will be placed at 80% of this maximum distance. The investigator will tell the participant to stand by, and then, within 4 to 10 seconds, an audible signal will indicate to the subject that he/she should perform the pointing movement. The procedure will repeat after a 4-10 second pause. For each session, 30 pointing movements reaching the target will be performed.
Primary Outcome Measure Information:
Title
Corticospinal excitability
Description
It will be measured using transcranial magnetic stimulation at different intensities in order to model I/O curves for each participant. Measurements will be taken before (pain-free condition) and after (pain condition) the application of a patch of capsaicin 1%, at the shoulder. Electromyographic signals, induced by the magnetic stimuli, will be captured with surface electrodes glued to the skin the anterior deltoid and upper trapezius muscles. To facilitate obtaining deltoid MEPs, participants will be asked to voluntarily contract 8-12% of their maximum voluntary contraction. The Boltzmann sigmoidal function will be used to fit the data points to construct the I/O curves. The mathematical modeling of the I/O curves allows the calculation of three parameters: the slope, the plateau, and the S50, the intensity allowing to obtain a response twice less than the maximum response. These 3 parameters will be used to compare them with the 2 conditions (before and after pain).
Time Frame
1 hour
Title
Kinesiophobia
Description
Kinesiophobia will be assessed using the French-Canadian version of the Tampa Kinesiophobia Questionnaire (EKT-CF). It takes the form of a self-reported questionnaire of 17 items using a Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with an acceptable degree of internal consistency (Cronbach's alpha = 0.71), satisfactory construct validity, and high sensitivity to change (intra-class correlation coefficient > 0.7). The total score is obtained by adding the value of the responses and is between 17 and 68. The value of 40/68 is considered as the threshold value at which kinesiophobia becomes significant.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Activation synergies
Description
Surface electromyogram recordings of the anterior deltoid and upper trapezius muscles will be made on the dominant upper limb performing a pointing task and on which the experimental pain will be induced (pre-post measurements). The activation synergies will be recorded (relative durations between the onset of different surface EMG puffs of the targeted muscles).
Time Frame
1 hour
Title
Kinematic parameters: Linearity of motion
Description
Trajectory length ratio (TLR), defined as the ratio of the total length of the trajectory traveled by the hand divided by the shortest length between the start and end points. A ratio of 1 indicates an ideal trajectory; as the ratio increases, the trajectory becomes less direct.
Time Frame
1 hour
Title
Kinematic parameters: Smoothness of motion
Description
The number of velocity peaks on the kinematic path of the index. The higher this number, the less regular the motion.
Time Frame
1 hour
Title
Kinematic parameters: Maximum directional error
Description
Maximum orthogonal distance between the hand position and the straight line connecting the start and end points.
Time Frame
1 hour
Title
EMG data and cumulative summation: The area of the puffs
Description
The value of the area under the curves between the beginning and the end of the puffs.
Time Frame
1 hour
Title
EMG data and cumulative summation: CUSUMs
Description
The value of the CUSUMs of each puff, which represents the small variations that may appear in surface EMG and may be masked by background fluctuations.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy subjects (who do not have self-reported neurological disorders) Subjects who have signed an informed consent (who have a good command of French) Subjects affiliated with or receiving social security benefits Exclusion Criteria: Psychiatric history obtained through physician questioning: individuals with mental retardation or severe impairment of cognitive, behavioral, or emotional function that precludes understanding the protocol and signing informed consent Neurological history (epilepsy, stroke, surgeries performed on the brain or spinal cord, and history of neurological diseases affecting motor skills and sensation) Subjects who are unable to receive informed information (dementia, hearing problems, poor French proficiency, etc.) Contraindications to MST (epilepsy, intracranial metal foreign bodies, hearing aids or cochlear implants) Taking psychotropic medications Persons under guardianship or conservatorship Pregnant and nursing women Subjects with pacemakers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hervé Dr Devanne, PhD
Phone
+33(0)320446354
Email
herve.devanne@univ-littoral.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud Duport, MSc
Phone
+33(0)608983499
Email
arnaud.duport@hotmail.fr
Facility Information:
Facility Name
Eurasport
City
Loos
State/Province
Nord
ZIP/Postal Code
59120
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serge Pr Berthoin, PhD
Phone
03 74 00 82 02
Email
serge.berthoin@univ-lille.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Adaptation of the Motor System to Experimental Pain

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