NCT07688525

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

June 25, 2026

Last Update Submit

July 2, 2026

Conditions

Keywords

Experimental painTopical capsaicinKinesiophobiaFear of movementMotor cortex excitabilityIntracortical excitabilityCorticospinal excitabilityTranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)

Secondary Outcomes (5)

  • Change in Short-Interval Intracortical Facilitation

    At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)

  • Change in Pain Intensity

    From baseline through completion of the experimental session, an average of 2 hours

  • Change in Intracortical Facilitation

    At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)

  • Change in Long-Interval Intracortical Inhibition

    At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)

  • Change from baseline in corticospinal excitability

    At baseline (before capsaicin cream application); at pain stabilization (after capsaicin cream application)

Other Outcomes (2)

  • Kinesiophobia

    Baseline

  • Pain catastrophizing related to pain

    Baseline

Study Arms (1)

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.

Drug: Topical Capsaicin Cream (1%)

Interventions

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.

Experimental pain

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 to 35 years, inclusive
  • Healthy
  • Able to understand the study information and experimental procedures
  • Able to provide informed consent

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Sherbrooke - Campus de la santé

Sherbrooke, Quebec, J1H 5H3, Canada

Location

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Guillaume Léonard, Ph.D.

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 7, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 7, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations