Kinesiophobia (Fear of Movement)NCT07688525
Pain Beliefs and Intracortical Excitability During Experimental Pain
A study testing Topical Capsaicin Cream (1%) in people with Kinesiophobia (Fear of Movement) and Experimental Pain, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Pain can influence the way the motor system functions. However, responses to pain vary widely between individuals, and this variability may be partly related to pain-related beliefs such as kinesiophobia. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Kinesiophobia (Fear of Movement), Experimental Pain
- What is being tested?
- Topical Capsaicin Cream (1%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 35 years, inclusive
- Healthy
- Able to understand the study information and experimental procedures
- Able to provide informed consent
Who cannot join
- History of psychiatric disorders (including intellectual disability or severe cognitive, behavioral, or affective impairment) that could interfere with understanding the study or providing informed consent.
- History of neurological disorders, including epilepsy, stroke, brain or spinal cord surgery, or any neurological disease affecting motor or sensory function.
- Inability to provide informed consent (e.g., dementia, significant hearing impairment, insufficient language proficiency).
- Any pain condition within the past 3 months, regardless of origin.
- Recent musculoskeletal injury or surgery within the past 3 months.
- Contraindications to transcranial magnetic stimulation (TMS), including a history of epilepsy or the presence of intracranial metallic objects, cochlear implants, or other non-removable metallic implants in or near the head.
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- Use of analgesic or psychotropic medications.
- Individuals under legal guardianship or curatorship.
- Pregnant or breastfeeding women.
- Presence of a cardiac pacemaker or other implanted electronic medical device.
- Known allergy or previous skin reaction to capsaicin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Université de Sherbrooke - Campus de la santé
Sherbrooke, Quebec, J1H 5H3
Guillaume Léonard, Ph.D., 819-821-8000, guillaume.leonard2@usherbrooke.ca
Adrien Nourry, +33611074458, adrien.nourry@usherbrooke.ca
About this study
Official title: Influence Of Pain-Related Beliefs On The Modulation Of Intracortical Circuits During Experimental Pain Induced By Topical Capsaicin
Pain can influence the way the motor system functions. However, responses to pain vary widely between individuals, and this variability may be partly related to pain-related beliefs such as kinesiophobia.
This study examines whether temporary experimental pain changes intracortical excitability in the motor cortex, and whether this response differs according to baseline kinesiophobia. Healthy adults will complete one experimental session. Motor cortex excitability will first be assessed at baseline using transcranial magnetic stimulation, a non-invasive brain stimulation technique. A topical capsaicin cream will then be applied to the forearm to induce temporary, moderate experimental pain. Once pain is established, the same neurophysiological assessments will be repeated.
Read more
The main objective is to measure changes in short-interval intracortical inhibition before and during capsaicin-induced pain, with particular attention to whether these changes are associated with baseline kinesiophobia.
Secondary objectives are to characterize other markers of motor cortex excitability, including long-interval intracortical inhibition, short-interval intracortical facilitation, intracortical facilitation, and corticospinal excitability assessed using input-output recruitment curves. Pain intensity will be monitored using a visual analog scale to characterize the experimental pain response. Baseline kinesiophobia will be assessed using the Tampa Scale of Kinesiophobia and examined as a factor associated with interindividual variability in neurophysiological responses to experimental pain.
The researchers expect that changes in motor cortex excitability during experimental pain will vary between individuals, and that individuals with higher kinesiophobia may show smaller changes in motor cortex excitability during capsaicin-induced pain.
Read the detailed description
Pain is not only a sensory experience. It is also influenced by psychological, emotional, and contextual factors, including how people interpret pain and the threat they associate with movement. In the presence of pain, individuals often modify the way they move. These adaptations may be protective in the short term, but when maintained over time, they may contribute to persistent movement avoidance and disability.
Within the fear-avoidance framework, kinesiophobia, or fear of movement, is considered an important factor in the relationship between pain, movement, and disability. Individuals with higher kinesiophobia may perceive movement as threatening or potentially harmful. This may influence not only motor behavior, but also the way the nervous system prepares and controls movement. However, the neurophysiological mechanisms linking pain-related beliefs, experimental pain, and motor control remain incompletely understood.
The primary motor cortex is a key brain region involved in voluntary movement. Its excitability can be assessed using transcranial magnetic stimulation, a non-invasive brain stimulation technique. When applied over the primary motor cortex, transcranial magnetic stimulation can evoke motor responses that are recorded from a target muscle using surface electromyography. These responses provide information about corticospinal excitability and about intracortical inhibitory and facilitatory mechanisms.
Previous studies suggest that experimental pain can modify motor cortex excitability, but the direction and magnitude of these changes vary considerably between individuals. Pain-related beliefs, especially kinesiophobia, may partly explain this variability. This study therefore focuses on whether experimental pain changes intracortical excitability in the motor cortex and whether this response differs according to baseline kinesiophobia.
The main objective is to quantify changes in short-interval intracortical inhibition before and during experimental pain induced by topical capsaicin, with particular attention to whether these changes vary according to the participant's baseline level of kinesiophobia. Short-interval intracortical inhibition is used as the primary neurophysiological measure because it reflects inhibitory activity within the motor cortex.
Secondary objectives are to characterize other markers of motor cortex excitability during experimental pain. These include long-interval intracortical inhibition, intracortical facilitation, and corticospinal excitability assessed using input-output recruitment curves. These complementary measures are included to provide a broader characterization of inhibitory, facilitatory, and corticospinal responses to experimental pain.
Healthy adults will complete one experimental session. At the beginning of the session, participants will complete questionnaires assessing pain-related beliefs, including kinesiophobia. Baseline neurophysiological assessments will then be performed using transcranial magnetic stimulation applied over the primary motor cortex, with electromyographic recordings from the first dorsal interosseous muscle of the hand.
After baseline measurements, topical capsaicin cream will be applied to the forearm to induce temporary, moderate experimental pain. Pain intensity will be monitored using a visual analog scale. Once experimental pain is established, the same transcranial magnetic stimulation assessments will be repeated.
Each participant serves as their own control, with neurophysiological measures compared between the baseline condition and the experimental pain condition. The investigators hypothesize that changes in motor cortex excitability during experimental pain will vary between individuals. This variability is expected to be partly related to kinesiophobia, with individuals reporting higher kinesiophobia showing smaller changes in motor cortex excitability during capsaicin-induced pain.
- Being tested
- Topical Capsaicin Cream (1%)
- Keywords
- Experimental pain, Topical capsaicin, Kinesiophobia, Fear of movement, Motor cortex excitability, Intracortical excitability, Corticospinal excitability, Transcranial magnetic stimulation
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Capsaicin Cream (1%)Drug
Topical capsaicin cream (1%) is applied to the forearm to induce temporary, moderate experimental pain. Motor cortex excitability is assessed before and during capsaicin-induced pain using transcranial magnetic stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental pain | Experimental | Participants complete one experimental session. Motor cortex excitability is first assessed at baseline using transcranial magnetic stimulation with electromyographic recordings from the first dorsal interosseous muscle. Topical capsaicin cream is then applied to the forearm to induce temporary, moderate experimental pain. Once pain is established, the same neurophysiological assessments are repeated during the pain condition. Receives: Drug: Topical Capsaicin Cream (1%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short-Interval Intracortical Inhibition
Short-interval intracortical inhibition will be assessed using paired-pulse transcranial magnetic stimulation over the primary motor cortex, with electromyographic recordings from the first dorsal interosseous muscle. A subthreshold conditioning stimulus set at 80% of resting motor threshold will be followed by a suprathreshold test stimulus set at 120% of resting motor threshold, with an interstimulus interval of 3 ms. Fifteen conditioned trials will be recorded for this measure. The outcome will be expressed as the change in conditioned motor evoked potential amplitude relative to the unconditioned test response from pre- to post-application of topical capsaicin cream.
Measured: At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)
Secondary outcomes (5)
Change in Short-Interval Intracortical Facilitation
Short-interval intracortical facilitation will be assessed using paired-pulse transcranial magnetic stimulation over the primary motor cortex, with electromyographic recordings from the first dorsal interosseous muscle. A suprathreshold conditioning stimulus set at 120% of resting motor threshold will be followed by a subthreshold test stimulus set at 80% of resting motor threshold, with an interstimulus interval of 2 ms. Fifteen conditioned trials will be recorded for this measure. The outcome will be expressed as the change in conditioned motor evoked potential amplitude relative to the unconditioned test response from pre- to post-application of topical capsaicin cream.
Measured: At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)
Change in Pain Intensity
Pain intensity will be assessed using a visual analog scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The outcome will be expressed as the change in pain intensity from pre- to post-application of topical capsaicin cream.
Measured: From baseline through completion of the experimental session, an average of 2 hours
Change in Intracortical Facilitation
Intracortical facilitation will be assessed using paired-pulse transcranial magnetic stimulation over the primary motor cortex, with electromyographic recordings from the first dorsal interosseous muscle. A subthreshold conditioning stimulus set at 80% of resting motor threshold will be followed by a suprathreshold test stimulus set at 120% of resting motor threshold, with an interstimulus interval of 15 ms. Fifteen conditioned trials will be recorded for this measure. The outcome will be expressed as the change in conditioned motor evoked potential amplitude relative to the unconditioned test response from pre- to post-application of topical capsaicin cream.
Measured: At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)
Change in Long-Interval Intracortical Inhibition
Long-interval intracortical inhibition will be assessed using paired-pulse transcranial magnetic stimulation over the primary motor cortex, with electromyographic recordings from the first dorsal interosseous muscle. A suprathreshold conditioning stimulus set at 120% of resting motor threshold will be followed by a suprathreshold test stimulus set at 120% of resting motor threshold, with an interstimulus interval of 100 ms. Fifteen conditioned trials will be recorded for this measure. The outcome will be expressed as the change in conditioned motor evoked potential amplitude relative to the unconditioned test response from pre- to post-application of topical capsaicin cream.
Measured: At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)
Change from baseline in corticospinal excitability
Corticospinal excitability will be assessed using single-pulse transcranial magnetic stimulation applied over the primary motor cortex, with electromyographic recordings from the first dorsal interosseous muscle. Single magnetic pulses of increasing intensity will be delivered to construct input-output recruitment curves for each participant. Stimulation intensity will be increased in 5% steps, and 10 stimuli will be delivered at each intensity level. Motor evoked potentials will be recorded using surface electromyography. Input-output curves will be modeled using a Boltzmann sigmoidal function, and the slope, plateau, and S50 parameters will be extracted. The outcome will be expressed as the change in these input-output curve parameters from pre- to post-application of topical capsaicin cream.
Measured: At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kinesiophobia (Fear of Movement)Studies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume Léonard, Université de Sherbrooke
- Investigators
- Guillaume Léonard, Ph.D., Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688525
- Sponsor's protocol ID
- 2027-6267
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence Of Pain-Related Beliefs On The Modulation Of Intracortical Circuits During Experimental Pain Induced By Topical Capsaicin
- ClinicalTrials.gov ID
- NCT07688525
- Acronym / sponsor ID
- 2027-6267
- Keywords
- Experimental pain, Topical capsaicin, Kinesiophobia, Fear of movement, Motor cortex excitability, Intracortical excitability, Corticospinal excitability, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Jul 2026 (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.
Pain can influence the way the motor system functions. However, responses to pain vary widely between individuals, and this variability may be partly related to pain-related beliefs such as kinesiophobia.
This study examines whether temporary experimental pain changes intracortical excitability in the motor cortex, and whether this response differs according to baseline kinesiophobia. Healthy adults will complete one experimental session. Motor cortex excitability will first be assessed at baseline using transcranial magnetic stimulation, a non-invasive brain stimulation technique. A topical capsaicin cream will then be applied to the forearm to induce temporary, moderate experimental pain. Once pain is established, the same neurophysiological assessments will be repeated.
The main objective is to measure changes in short-interval intracortical inhibition before and during capsaicin-induced pain, with particular attention to whether these changes are associated with baseline kinesiophobia.
Secondary objectives are to characterize other markers of motor cortex excitability, including long-interval intracortical inhibition, short-interval intracortical facilitation, intracortical facilitation, and corticospinal excitability assessed using input-output recruitment curves. Pain intensity will be monitored using a visual analog scale to characterize the experimental pain response. Baseline kinesiophobia will be assessed using the Tampa Scale of Kinesiophobia and examined as a factor associated with interindividual variability in neurophysiological responses to experimental pain.
The researchers expect that changes in motor cortex excitability during experimental pain will vary between individuals, and that individuals with higher kinesiophobia may show smaller changes in motor cortex excitability during capsaicin-induced pain.
Detailed description
Pain is not only a sensory experience. It is also influenced by psychological, emotional, and contextual factors, including how people interpret pain and the threat they associate with movement. In the presence of pain, individuals often modify the way they move. These adaptations may be protective in the short term, but when maintained over time, they may contribute to persistent movement avoidance and disability.
Within the fear-avoidance framework, kinesiophobia, or fear of movement, is considered an important factor in the relationship between pain, movement, and disability. Individuals with higher kinesiophobia may perceive movement as threatening or potentially harmful. This may influence not only motor behavior, but also the way the nervous system prepares and controls movement. However, the neurophysiological mechanisms linking pain-related beliefs, experimental pain, and motor control remain incompletely understood.
The primary motor cortex is a key brain region involved in voluntary movement. Its excitability can be assessed using transcranial magnetic stimulation, a non-invasive brain stimulation technique. When applied over the primary motor cortex, transcranial magnetic stimulation can evoke motor responses that are recorded from a target muscle using surface electromyography. These responses provide information about corticospinal excitability and about intracortical inhibitory and facilitatory mechanisms.
Previous studies suggest that experimental pain can modify motor cortex excitability, but the direction and magnitude of these changes vary considerably between individuals. Pain-related beliefs, especially kinesiophobia, may partly explain this variability. This study therefore focuses on whether experimental pain changes intracortical excitability in the motor cortex and whether this response differs according to baseline kinesiophobia.
The main objective is to quantify changes in short-interval intracortical inhibition before and during experimental pain induced by topical capsaicin, with particular attention to whether these changes vary according to the participant's baseline level of kinesiophobia. Short-interval intracortical inhibition is used as the primary neurophysiological measure because it reflects inhibitory activity within the motor cortex.
Secondary objectives are to characterize other markers of motor cortex excitability during experimental pain. These include long-interval intracortical inhibition, intracortical facilitation, and corticospinal excitability assessed using input-output recruitment curves. These complementary measures are included to provide a broader characterization of inhibitory, facilitatory, and corticospinal responses to experimental pain.
Healthy adults will complete one experimental session. At the beginning of the session, participants will complete questionnaires assessing pain-related beliefs, including kinesiophobia. Baseline neurophysiological assessments will then be performed using transcranial magnetic stimulation applied over the primary motor cortex, with electromyographic recordings from the first dorsal interosseous muscle of the hand.
After baseline measurements, topical capsaicin cream will be applied to the forearm to induce temporary, moderate experimental pain. Pain intensity will be monitored using a visual analog scale. Once experimental pain is established, the same transcranial magnetic stimulation assessments will be repeated.
Each participant serves as their own control, with neurophysiological measures compared between the baseline condition and the experimental pain condition. The investigators hypothesize that changes in motor cortex excitability during experimental pain will vary between individuals. This variability is expected to be partly related to kinesiophobia, with individuals reporting higher kinesiophobia showing smaller changes in motor cortex excitability during capsaicin-induced pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental pain | Experimental | Drug: Topical Capsaicin Cream (1%)Participants complete one experimental session. Motor cortex excitability is first assessed at baseline using transcranial magnetic stimulation with electromyographic recordings from the first dorsal interosseous muscle. Topical capsaicin cream is then applied to the forearm to induce temporary, moderate experimental pain. Once pain is established, the same neurophysiological assessments are repeated during the pain condition. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18 to 35 years, inclusive
- Healthy
- Able to understand the study information and experimental procedures
- Able to provide informed consent
Key exclusion criteria (11 listed)
- History of psychiatric disorders (including intellectual disability or severe cognitive, behavioral, or affective impairment) that could interfere with understanding the study or providing informed consent.
- History of neurological disorders, including epilepsy, stroke, brain or spinal cord surgery, or any neurological disease affecting motor or sensory function.
- Inability to provide informed consent (e.g., dementia, significant hearing impairment, insufficient language proficiency).
- Any pain condition within the past 3 months, regardless of origin.
- Recent musculoskeletal injury or surgery within the past 3 months.
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 |
|---|---|---|
| Topical Capsaicin Cream (1%)Topical capsaicin cream (1%) is applied to the forearm to induce temporary, moderate experimental pain. Motor cortex excitability is assessed before and during capsaicin-induced pain using transcranial magnetic stimulation. | Drug | Experimental pain |
Primary outcome
Change in Short-Interval Intracortical Inhibition
Time frame: At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)
Short-interval intracortical inhibition will be assessed using paired-pulse transcranial magnetic stimulation over the primary motor cortex, with electromyographic recordings from the first dorsal interosseous muscle. A subthreshold conditioning stimulus set at 80% of resting motor threshold will be followed by a suprathreshold test stimulus set at 120% of resting motor threshold, with an interstimulus interval of 3 ms. Fifteen conditioned trials will be recorded for this measure. The outcome will be expressed as the change in conditioned motor evoked potential amplitude relative to the unconditioned test response from pre- to post-application of topical capsaicin cream.
5 secondary outcomes
Change in Short-Interval Intracortical Facilitation
Time frame: At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)
Change in Pain Intensity
Time frame: From baseline through completion of the experimental session, an average of 2 hours
Change in Intracortical Facilitation
Time frame: At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)
Change in Long-Interval Intracortical Inhibition
Time frame: At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)
Change from baseline in corticospinal excitability
Time frame: At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- 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.
Guillaume Léonard, Ph.D. principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Capsaicin Cream (1%) in people with Kinesiophobia (Fear of Movement) and Experimental Pain, run by Université de Sherbrooke at 1 site in Canada.
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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 7 Jul 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Léonard, Ph.D. (819-821-8000, guillaume.leonard2@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short-Interval Intracortical Inhibition (time frame: At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.