KinesiophobiaKinesioPointNCT05396820
Adaptation of the Motor System to Experimental Pain
A study testing Experimental pain in people with Kinesiophobia and Pain, Acute, run by Universite du Littoral Cote d'Opale at 1 site in France.
Trial summary
This study aims to measure the impact of an experimental pain on electromyography, kinematics of motion and motor cortical excitability. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Kinesiophobia, Pain, Acute
- What is being tested?
- Experimental pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2022to 31 Oct 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to measure the impact of an experimental pain on electromyography, kinematics of motion and motor cortical excitability.
Read the 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).
- Conditions
- Kinesiophobia, Pain, Acute
- Being tested
- Experimental pain
- Keywords
- kinesiophobia, experimental pain, corticospinal excitability, motor control, CUSOM
- Medical subject headings
- Kinesiophobia, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental painOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental pain | Experimental | Experimental pain will be induced at the level of the dominant delto-pectoral groove of the participant (between the shoulder stump and the pectoral). Receives: Other: Experimental pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 hour
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.
Measured: 5 minutes
Secondary outcomes (6)
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).
Measured: 1 hour
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.
Measured: 1 hour
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.
Measured: 1 hour
Kinematic parameters: Maximum directional error
Maximum orthogonal distance between the hand position and the straight line connecting the start and end points.
Measured: 1 hour
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.
Measured: 1 hour
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start5 Sep 2022
- Primary completion28 Oct 2022
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KinesiophobiaStudies of the same condition, open and under way.
- 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
- Model description
- Cross sectional study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universite du Littoral Cote d'Opale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396820
- Sponsor's protocol ID
- 2022-A00271-42
- Acronym
- KinesioPoint
- Status last verified
- May 2024
- First submitted
- 18 May 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duport A, Morel P, Leonard G, Devanne H. The influence of pain and kinesiophobia on motor control of the upper limb: how pointing task paradigms can point to new avenues of understanding. Pain. 2024 Sep 1;165(9):2044-2054. doi: 10.1097/j.pain.0000000000003213. Epub 2024 Mar 13.
PubMed 38501987
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the Motor System to Experimental Pain
- ClinicalTrials.gov ID
- NCT05396820
- Acronym / sponsor ID
- KinesioPoint / 2022-A00271-42
- Conditions
- Kinesiophobia, Pain, Acute
- Keywords
- kinesiophobia, experimental pain, corticospinal excitability, motor control, CUSOM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universite du Littoral Cote d'OpaleUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 31 May 2022 (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 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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross sectional study
| Arm | Type | Receives |
|---|---|---|
| Experimental pain | Experimental | Other: Experimental painExperimental pain will be induced at the level of the dominant delto-pectoral groove of the participant (between the shoulder stump and the pectoral). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Experimental painExperimental 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. | Other | Experimental pain |
Primary outcome
Corticospinal excitability
Time frame: 1 hour
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
Time frame: 5 minutes
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.
6 secondary outcomes
Activation synergies
Time frame: 1 hour
Kinematic parameters: Linearity of motion
Time frame: 1 hour
Kinematic parameters: Smoothness of motion
Time frame: 1 hour
Kinematic parameters: Maximum directional error
Time frame: 1 hour
EMG data and cumulative summation: The area of the puffs
Time frame: 1 hour
EMG data and cumulative summation: CUSUMs
Time frame: 1 hour
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 16 May 2024.
- Derived from this study: PubMed 38501987Duport A, Morel P, Leonard G, Devanne H. The influence of pain and kinesiophobia on motor control of the upper limb: how pointing task paradigms can point to new avenues of understanding. Pain. 2024 Sep 1;165(9):2044-2054. doi: 10.1097/j.pain.0000000000003213. Epub 2024 Mar 13.
- Individual participant dataSharing planned: No
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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 Experimental pain in people with Kinesiophobia and Pain, Acute, run by Universite du Littoral Cote d'Opale at 1 site in France.
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 3 inclusion and 8 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 16 May 2024. 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 France. 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?
Corticospinal excitability (time frame: 1 hour). 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?
On the ClinicalTrials.gov record for NCT05396820, which also lists 1 linked publication.
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 16 May 2024.