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Pain-Related Fear and Motor Control in Healthy Volunteers (Domokiss)

6 juli 2026 bijgewerkt door: Adrien Nourry, Universite de Picardie Jules Verne

Understanding the Interaction Between Pain-Related Fear and Motor Control: Manipulating Movement-Related Threat in Healthy Volunteers

The goal of this clinical trial is to learn how experimentally induced movement-related threat affects emotional, autonomic, and motor responses in healthy adults. The main questions it aims to answer are:

  • Does movement-related threat change walking performance or upper-limb pointing movements?
  • Are these effects moderated by participants' level of kinesiophobia?
  • Does movement-related threat increase apprehension or alter heart rate variability responses?

Participants will complete two experimental conditions during one session: a control condition and an experimental condition. In both conditions, inactive transcutaneous electrical nerve stimulation (TENS) electrodes will be placed in the lumbar region. In the experimental condition, participants will receive verbal suggestions about discomfort, movement-evoked pain, and potential unpredictable electrical stimulation to create the threat of pain associated with movement. Participants will complete a baseline assessment of kinesiophobia, followed by walking and pointing tasks, while perceived apprehension and autonomic responses are assessed.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

In the presence of pain, individuals often modify the way they move. However, pain-related motor adaptations cannot be understood solely as responses to nociceptive input, as pain is shaped by a complex interplay of individual and contextual factors. As a result, motor behavior may be influenced not only by pain itself, but also by the anticipation that movement could be painful or harmful, thereby becoming a perceived threat. Within the fear-avoidance framework, fear of movement and pain-related threat are considered important factors influencing motor behavior and autonomic responses. As pain-related apprehension and kinesiophobia may also be present in pain-free individuals, experimental paradigms inducing movement-related threat in healthy participants may help clarify the mechanisms underlying behavioral adaptations associated with pain-related fear and kinesiophobia.

The main objective of this study, which was concealed from participants, was to determine how movement-related threat influences motor behavior. Specifically, the study assessed whether a verbally induced threat affects walking parameters and upper-limb pointing movement time. A secondary objective was to examine whether baseline trait kinesiophobia moderates the effects of movement-related threat on motor behavior.

This study uses a randomized within-subject crossover design to investigate the effects of experimentally induced movement-related threat on motor responses, perceived apprehension, and autonomic responses in healthy adults. Participants complete two experimental conditions during a single experimental session: a control condition and an experimental threat condition. In both conditions, inactive transcutaneous electrical nerve stimulation electrodes are placed in the lumbar region. In the control condition, electrodes are presented as safe and reliable, without any threat-related information. In the experimental condition, participants receive verbal suggestions regarding discomfort, movement-evoked pain, and unpredictable electrical stimulation associated with the device, in order to induce movement-related apprehension.

Motor behavior is evaluated through spatiotemporal gait parameters during walking and movement time during upper-limb pointing movements toward visual targets. Autonomic nervous system responses are assessed using heart rate and heart rate variability analysis from a wearable heart rate monitor. Perceived apprehension is assessed using visual analog scales. Baseline trait kinesiophobia is assessed at the beginning of the session and used as a continuous variable in the analyses.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

26

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • Age between 18 and 65 years.
  • Ability to understand the experimental instructions and questionnaires.
  • No pain at inclusion and during the last 3 months.
  • Abstinence from short-term analgesics for 2 hours before testing.
  • Abstinence from coffee and cigarette smoking for 6 hours before testing.

Exclusion Criteria:

  • History of chronic pain.
  • Motor, neurological, or sensory disorders.
  • Cardiovascular conditions likely to affect physiological measurements.
  • Clinically significant depressive symptoms or anxiety scores on the Hospital Anxiety and Depression Scale.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Sham-vergelijker: Control electrodes
Participants were exposed to control electrodes described as safe and reliable, without threat-related information. Participants then completed autonomic, walking, and pointing assessments.
Gedragsmatig: Neutral Movement Condition
Control condition using verbal suggestions about the safety and reliability of electrodes placed in the lumbar region and associated with an inactive transcutaneous electrical nerve stimulation device. No threat-related information regarding discomfort, movement-evoked pain, or unpredictable electrical stimulation was provided. The condition aimed to assess motor and autonomic responses during motor tasks under neutral instructions.
Experimenteel: Experimental electrodes
Participants were exposed to experimental electrodes associated with verbal information suggesting discomfort, movement-evoked pain, and unpredictable electrical stimulation during movement. The transcutaneous electrical nerve stimulation device was inactive but emitted a sound to reinforce the threat manipulation. Participants then completed autonomic, walking, and pointing assessments.
Gedragsmatig: Movement-Related Threat Induction
Experimental induction of movement-related threat using verbal suggestions about potential discomfort and movement-evoked pain associated with electrodes placed in the lumbar region, as well as unpredictable electrical stimulation from an inactive transcutaneous electrical nerve stimulation device. The manipulation aimed to increase movement-related apprehension and anxiety during motor tasks.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Difference in walking speed between the control electrode and experimental electrode conditions
Tijdsspanne: Day 1, during the walking task under each randomized electrode condition
Walking speed will be assessed during the walking task using the GAITRite electronic walkway system. Walking speed will be expressed in meters per second and compared between the control and experimental electrode conditions.
Day 1, during the walking task under each randomized electrode condition
Difference in walking cadence between the control electrode and experimental electrode conditions
Tijdsspanne: Day 1, during the walking task under each randomized electrode condition
Walking cadence will be assessed during the walking task using the GAITRite electronic walkway system. Walking cadence will be expressed in steps per minute and compared between the control and experimental electrode conditions.
Day 1, during the walking task under each randomized electrode condition
Difference in walking stride length between the control electrode and experimental electrode conditions
Tijdsspanne: Day 1, during the walking task under each randomized electrode condition
Walking stride length will be assessed during the walking task using the GAITRite electronic walkway system. Walking stride length will be expressed in meters and compared between the control and experimental electrode conditions.
Day 1, during the walking task under each randomized electrode condition
Difference in upper-limb pointing movement time between the control electrode and experimental electrode conditions
Tijdsspanne: Day 1, during the upper-limb pointing task under each randomized electrode condition
Upper-limb pointing movement time will be assessed during the pointing task using a custom Arduino-based device. Movement time will correspond to the interval between finger lift-off from the starting position and contact with the illuminated target, and will be expressed in milliseconds. Movement time will be assessed across four target locations: ipsilateral 80%, ipsilateral 110%, contralateral 80%, and contralateral 110% of arm length. Movement time will be compared between the control and experimental electrode conditions.
Day 1, during the upper-limb pointing task under each randomized electrode condition

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Kinesiophobia
Tijdsspanne: Baseline
Kinesiophobia will be assessed using the French-Canadian version of the Tampa Scale for Kinesiophobia (TSK-CF). It is a 17-item self-report questionnaire using a Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The total score is obtained by adding the item scores and ranges from 17 to 68. A score of 37 out of 68 is considered the threshold at which kinesiophobia becomes significant.
Baseline
Change from Baseline in heart rate variability
Tijdsspanne: Day 1: baseline, during the control electrode condition, and during the experimental electrode condition
Heart rate variability (HRV) will be assessed as an index of autonomic nervous system activity. Intervals between successive R waves (R-R intervals) will be continuously recorded throughout the single assessment session, starting with the baseline resting period and continuing through the control and experimental electrode conditions. The root mean square of successive differences (RMSSD) will be derived from the continuous recording to evaluate autonomic responses associated with pain anticipation.
Day 1: baseline, during the control electrode condition, and during the experimental electrode condition
Change from baseline in perceived apprehension
Tijdsspanne: Day 1: baseline, during the control electrode condition, and during the experimental electrode condition
Perceived apprehension related to the experimental context will be assessed using a 0-10 visual analogue scale, where 0 indicates "no apprehension at all" and 10 indicates "the highest apprehension imaginable." Participants will rate their apprehension in order to evaluate changes in apprehension associated with the experimental instructions and procedures.
Day 1: baseline, during the control electrode condition, and during the experimental electrode condition

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Brief Pain Inventory
Tijdsspanne: Baseline
Current pain status will be assessed using the Brief Pain Inventory, French version (BPI-FR), a self-report questionnaire widely used to evaluate pain severity and pain-related interference with daily activities. In this study, the BPI-FR is used to confirm the absence of clinically relevant pain at inclusion. The questionnaire includes 11 items: four items assessing pain intensity and seven items assessing the extent to which pain interferes with daily functioning, mood, sleep, and social activities. Pain intensity and interference are rated on numeric scales ranging from 0 (no pain or no interference) to 10 (worst imaginable pain or complete interference). Higher scores indicate greater pain severity and impact.
Baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universite de Picardie Jules Verne

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

3 november 2025

Primaire voltooiing (Werkelijk)

6 juli 2026

Studie voltooiing (Werkelijk)

6 juli 2026

Studieregistratiedata

Eerst ingediend

21 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 juni 2026

Eerst geplaatst (Werkelijk)

9 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

6 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AN-2026-001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be publicly shared.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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