Pain-related FearDomokissNCT07636603
Pain-Related Fear and Motor Control in Healthy Volunteers
A study testing Movement-Related Threat Induction and Neutral Movement Condition in people with Pain-related Fear and Kinesiophobia (Fear of Movement), run by Universite de Picardie Jules Verne at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain-related Fear, Kinesiophobia (Fear of Movement), Movement-Related Threat
- What is being tested?
- Movement-Related Threat Induction and Neutral Movement Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2025to 6 Jul 2026
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Movement-Related Threat Induction, Neutral Movement Condition
- Keywords
- Pain-related fear, Threat manipulation, Anxiety, Motor control, Movement-related fear, Pointing task, Walking task, Kinesiophobia
- Medical subject headings
- Kinesiophobia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement-Related Threat InductionBehavioural
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.
Neutral Movement ConditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control electrodes | Sham comparator | Participants were exposed to control electrodes described as safe and reliable, without threat-related information. Participants then completed autonomic, walking, and pointing assessments. Receives: Behavioral: Neutral Movement Condition |
| Experimental electrodes | Experimental | 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. Receives: Behavioral: Movement-Related Threat Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in walking speed between the control electrode and experimental electrode conditions
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.
Measured: Day 1, during the walking task under each randomized electrode condition
Difference in walking cadence between the control electrode and experimental electrode conditions
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.
Measured: Day 1, during the walking task under each randomized electrode condition
Difference in walking stride length between the control electrode and experimental electrode conditions
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.
Measured: 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
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.
Measured: Day 1, during the upper-limb pointing task under each randomized electrode condition
Secondary outcomes (3)
Kinesiophobia
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.
Measured: Baseline
Change from Baseline in heart rate variability
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.
Measured: Day 1: baseline, during the control electrode condition, and during the experimental electrode condition
Change from baseline in perceived apprehension
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.
Measured: Day 1: baseline, during the control electrode condition, and during the experimental electrode condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start3 Nov 2025
- Primary completion6 Jul 2026
- Study completion6 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain-related FearStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Participants underwent two conditions (control and experimental) in a randomized crossover within-subject design during a single experimental session.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universite de Picardie Jules Verne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrien Nourry, Universite de Picardie Jules Verne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636603
- Sponsor's protocol ID
- AN-2026-001
- Acronym
- Domokiss
- Status last verified
- Jul 2026
- First submitted
- 21 May 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Interaction Between Pain-Related Fear and Motor Control: Manipulating Movement-Related Threat in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07636603
- Acronym / sponsor ID
- Domokiss / AN-2026-001
- Keywords
- Pain-related fear, Threat manipulation, Anxiety, Motor control, Movement-related fear, Pointing task, Walking task, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universite de Picardie Jules VerneUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- 6 Jul 2026 (actual)
- First posted
- 9 Jun 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants underwent two conditions (control and experimental) in a randomized crossover within-subject design during a single experimental session.
| Arm | Type | Receives |
|---|---|---|
| Control electrodes | Sham comparator | Behavioral: Neutral Movement ConditionParticipants were exposed to control electrodes described as safe and reliable, without threat-related information. Participants then completed autonomic, walking, and pointing assessments. |
| Experimental electrodes | Experimental | Behavioral: Movement-Related Threat InductionParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Movement-Related Threat InductionExperimental 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. | Behavioural | Experimental electrodes |
| Neutral Movement ConditionControl 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. | Behavioural | Control electrodes |
Primary outcome
Difference in walking speed between the control electrode and experimental electrode conditions
Time frame: 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.
Difference in walking cadence between the control electrode and experimental electrode conditions
Time frame: 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.
Difference in walking stride length between the control electrode and experimental electrode conditions
Time frame: 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.
Difference in upper-limb pointing movement time between the control electrode and experimental electrode conditions
Time frame: 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.
3 secondary outcomes
Kinesiophobia
Time frame: Baseline
Change from Baseline in heart rate variability
Time frame: Day 1: baseline, during the control electrode condition, and during the experimental electrode condition
Change from baseline in perceived apprehension
Time frame: Day 1: baseline, during the control electrode condition, and during the experimental electrode condition
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 8 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared.
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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 Movement-Related Threat Induction and Neutral Movement Condition in people with Pain-related Fear and Kinesiophobia (Fear of Movement), run by Universite de Picardie Jules Verne 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 5 inclusion and 4 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 8 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 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. Some participants in this study may receive a placebo. 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?
Difference in walking speed between the control electrode and experimental electrode conditions (time frame: Day 1, during the walking task under each randomized electrode condition). The study lists 4 primary outcomes in all. 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 8 Jul 2026.