PainNCT07251387
Muscle Synergies in Pain and Pain Anticipation
A study testing Pain expectation conditioning and Gait assesment in people with Pain and Nocebo Effect, run by Universite de Picardie Jules Verne at 2 sites in 2 countries.
Trial summary
This study investigates how the anticipation of pain affects muscle synergies. One group will be recruited who will first experience actual pain from capsaicin cream and are then presented with a harmless cream deceptively labeled as capsaicin. The changes in muscle synergies will be measured during walking tasks. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Nocebo Effect, Pain Anticipation
- What is being tested?
- Pain expectation conditioning and Gait assesment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2026to 1 Oct 2027
- 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 18-35 years old
- Healthy participant with no self-reported diagnosed neurological, musculoskeletal, or cardiovascular disorders
- Body Mass Index (BMI) < 30
- Ability to walk unaided for at least 10 minutes without major physical limitations
Who cannot join
- Presence of pain at the time of testing
- Self-reported diagnosed condition affecting mobility
- Known allergy to any component of the study cream
- Allergy to EMG electrode adhesives
- Inability to stand unassisted for more than 1 minute
- Inability to walk/run at the required speed and distance
Show all 15Show fewer
- Weight exceeding 150 kg (due to treadmill limitations)
- Recent intake (prior intervention) of:
- Analgesics (within 6 hours)
- Cigarettes (within 6 hours)
- Caffeine (within 2 hours)
- Skin lesions at the cream application site
- Pregnancy
- Failure to understand instructions
- Daytime pain reported by participant on day of experimentation
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Canada1 site, 1 recruiting
- Recruiting
Centre de Recherche sur le Vieillissement
Sherbrooke
Guillaume Léonard, PhD, 819-829-7131, guillaume.leonard2@usherbrooke.ca
France1 site, 1 recruiting
- Recruiting
Université de Picardie Jules Verne
Amiens
Said Ahmaidi, +33 3 22 82 74 41, said.ahmaidi@u-picardie.fr
About this study
Official title: Test-retest Fidelity of a Tool for Calculation of Muscle Synergies
This study investigates how the anticipation of pain affects muscle synergies. One group will be recruited who will first experience actual pain from capsaicin cream and are then presented with a harmless cream deceptively labeled as capsaicin. The changes in muscle synergies will be measured during walking tasks.
Read the detailed description
Participants will be recruited through university announcements. Eligibility will be determined by a screening process that assesses prior experience with capsaicin cream. Healthy adults aged 18-35 who meet the inclusion criteria will be enrolled and assigned to experimental Group ("Prior Experience"): Individuals who report a prior painful experience with capsaicin cream.
Participants will complete a first session consisting on a walking assessment on a treadmill. The speed will be incrementally increased from 0.8 m/s to 1.1 m/s. Throughout this task, muscle activity will be recorded via electromyography (EMG), and ground reaction forces will be captured by force platforms embedded in the treadmill.
Following the initial walk, participants will complete a set of standardized questionnaires to establish baseline scores for pain perception (Visual Analog Scale, VAS), fear of movement (Tampa Scale of Kinesiophobia, TSK), and pain catastrophizing (Pain Catastrophizing Scale, PCS).
Then, a capsaicin cream will be applied to the knee, specifically in the area between the lateral epicondyles of the femur, in a 4 cm wide band. Participants will immediately fill out the VAS to report any pain sensations. The walking assessment is repeated, measuring the same physiological signals (EMG and ground reaction forces).
The participants will come to the laboratory a second time to measure the same outcomes but, instead of applying capsaicin again, they will receive an inert cream presented as capsaicin (neutral massage cream MEDICAFARM). The procedure will be repeated.
The primary objective is to determine whether a prior painful experience with capsaicin causes individuals to generalize that pain memory to a neutral sensation, leading to different outcomes than in those who only have a negative expectation. We will specifically investigate the magnitude of this effect on muscle synergies.
- Conditions
- Pain, Nocebo Effect, Pain Anticipation
- Being tested
- Pain expectation conditioning, Gait assesment
- Keywords
- Nocebo effect, Pain anticipation, Pain, Gait, Motricity, Muscle synergies
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain expectation conditioningOther
Participants receive a neutral cream with no real harmful effects with verbal and behavioral suggestions that it may cause localized pain. Researchers wear gloves during application and emphasize the potential discomfort, stating effects may intensify with movement.
Gait assesmentOther
Gait will be assessed both before and after cream application. Each assessment will consist of walking on a treadmill at varying speeds while physiological data (EMG) is recorded. Identical questionnaires (VAS, TAMPA, and PCS) will be administered immediately following the first gait assessment.
| Study group | Role | What they receive |
|---|---|---|
| Prior Experience Group | Experimental | Participants in this arm have experienced capsaicin cream before and will be given a neutral cream. They will be told that the cream contains capsaicin and will cause pain. Receives: Other: Pain expectation conditioning; Other: Gait assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of muscle synergies derived by non-negative matrix factorization
Changes in the activation of the muscle synergies during the gait cycle.
Measured: Before intervention, after intervention (10 minutes after cream application)
Changes in Muscle Synergy Composition derived by non-negative matrix factorization.
Changes in the composition of muscle synergies (i.e., the individuals muscles that comform one muscle synergy)
Measured: Before intervention, after intervention (10 minutes after cream application)
Secondary outcomes (1)
Tampa Scale for Kinesiophobia (TSK)
Tampa Scale of Kinesiophobia total score (17-68). Users rate 17 statements in a scale from 1 (Strongly disagree) to 4 (Strongly agree).
Measured: Before intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Jan 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universite de Picardie Jules Verne
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs
- Responsible party
- Principal investigator, Jennifer Burgos Tirado, Universite de Picardie Jules Verne
- Investigators
- Thierry Lelard, PhD, HDR, Study director, LecturerMaryne Cozette, PhD, Lecturer, Study director, LecturerGuillaume Léonard, PhD, Lecturer, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251387
- Sponsor's protocol ID
- 2025-5551-1H
- Status last verified
- Jun 2026
- First submitted
- 22 Sep 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants consented to data use only for this specific study under approved protocols. Regulations prohibit broad sharing of pseudonymized sensor/video data that could potentially be re-identified (e.g., physical features in GoPro videos, unique gait patterns).
Publications
Nishi Y, Osumi M, Sumitani M, Yozu A, Morioka S. Kinematic changes in goal-directed movements in a fear-conditioning paradigm. Sci Rep. 2021 May 27;11(1):11162. doi: 10.1038/s41598-021-90518-7.
PubMed 34045515Horvath A, Koteles F, Szabo A. Nocebo effects on motor performance: A systematic literature review. Scand J Psychol. 2021 Oct;62(5):665-674. doi: 10.1111/sjop.12753. Epub 2021 Jun 18.
PubMed 34145580Escalona MJ, Bourbonnais D, Goyette M, Le Flem D, Duclos C, Gagnon DH. Effects of Varying Overground Walking Speeds on Lower-Extremity Muscle Synergies in Healthy Individuals. Motor Control. 2021 Jan 27;25(2):234-251. doi: 10.1123/mc.2020-0008.
PubMed 33503586
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-retest Fidelity of a Tool for Calculation of Muscle Synergies
- ClinicalTrials.gov ID
- NCT07251387
- Acronym / sponsor ID
- 2025-5551-1H
- Conditions
- Pain, Nocebo Effect, Pain Anticipation
- Keywords
- Nocebo effect, Pain anticipation, Pain, Gait, Motricity, Muscle synergies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Universite de Picardie Jules VerneUniversity, hospital or other
- Collaborators
- Mitacs
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 26 Nov 2025 (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 investigates how the anticipation of pain affects muscle synergies. One group will be recruited who will first experience actual pain from capsaicin cream and are then presented with a harmless cream deceptively labeled as capsaicin. The changes in muscle synergies will be measured during walking tasks.
Detailed description
Participants will be recruited through university announcements. Eligibility will be determined by a screening process that assesses prior experience with capsaicin cream. Healthy adults aged 18-35 who meet the inclusion criteria will be enrolled and assigned to experimental Group ("Prior Experience"): Individuals who report a prior painful experience with capsaicin cream.
Participants will complete a first session consisting on a walking assessment on a treadmill. The speed will be incrementally increased from 0.8 m/s to 1.1 m/s. Throughout this task, muscle activity will be recorded via electromyography (EMG), and ground reaction forces will be captured by force platforms embedded in the treadmill.
Following the initial walk, participants will complete a set of standardized questionnaires to establish baseline scores for pain perception (Visual Analog Scale, VAS), fear of movement (Tampa Scale of Kinesiophobia, TSK), and pain catastrophizing (Pain Catastrophizing Scale, PCS).
Then, a capsaicin cream will be applied to the knee, specifically in the area between the lateral epicondyles of the femur, in a 4 cm wide band. Participants will immediately fill out the VAS to report any pain sensations. The walking assessment is repeated, measuring the same physiological signals (EMG and ground reaction forces).
The participants will come to the laboratory a second time to measure the same outcomes but, instead of applying capsaicin again, they will receive an inert cream presented as capsaicin (neutral massage cream MEDICAFARM). The procedure will be repeated.
The primary objective is to determine whether a prior painful experience with capsaicin causes individuals to generalize that pain memory to a neutral sensation, leading to different outcomes than in those who only have a negative expectation. We will specifically investigate the magnitude of this effect on muscle synergies.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prior Experience Group | Experimental | Other: Pain expectation conditioning, Other: Gait assesmentParticipants in this arm have experienced capsaicin cream before and will be given a neutral cream. They will be told that the cream contains capsaicin and will cause pain. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-35 years old
- Healthy participant with no self-reported diagnosed neurological, musculoskeletal, or cardiovascular disorders
- Body Mass Index (BMI) < 30
- Ability to walk unaided for at least 10 minutes without major physical limitations
Key exclusion criteria (15 listed)
- Presence of pain at the time of testing
- Self-reported diagnosed condition affecting mobility
- Known allergy to any component of the study cream
- Allergy to EMG electrode adhesives
- Inability to stand unassisted for more than 1 minute
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 |
|---|---|---|
| Pain expectation conditioningParticipants receive a neutral cream with no real harmful effects with verbal and behavioral suggestions that it may cause localized pain. Researchers wear gloves during application and emphasize the potential discomfort, stating effects may intensify with movement. | Other | Prior Experience Group |
| Gait assesmentGait will be assessed both before and after cream application. Each assessment will consist of walking on a treadmill at varying speeds while physiological data (EMG) is recorded. Identical questionnaires (VAS, TAMPA, and PCS) will be administered immediately following the first gait assessment. | Other | Prior Experience Group |
Primary outcome
Distribution of muscle synergies derived by non-negative matrix factorization
Time frame: Before intervention, after intervention (10 minutes after cream application)
Changes in the activation of the muscle synergies during the gait cycle.
Changes in Muscle Synergy Composition derived by non-negative matrix factorization.
Time frame: Before intervention, after intervention (10 minutes after cream application)
Changes in the composition of muscle synergies (i.e., the individuals muscles that comform one muscle synergy)
1 secondary outcome
Tampa Scale for Kinesiophobia (TSK)
Time frame: Before intervention.
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 11 Jun 2026.
- Background: PubMed 34045515Nishi Y, Osumi M, Sumitani M, Yozu A, Morioka S. Kinematic changes in goal-directed movements in a fear-conditioning paradigm. Sci Rep. 2021 May 27;11(1):11162. doi: 10.1038/s41598-021-90518-7.
- Background: PubMed 34145580Horvath A, Koteles F, Szabo A. Nocebo effects on motor performance: A systematic literature review. Scand J Psychol. 2021 Oct;62(5):665-674. doi: 10.1111/sjop.12753. Epub 2021 Jun 18.
- Background: PubMed 33503586Escalona MJ, Bourbonnais D, Goyette M, Le Flem D, Duclos C, Gagnon DH. Effects of Varying Overground Walking Speeds on Lower-Extremity Muscle Synergies in Healthy Individuals. Motor Control. 2021 Jan 27;25(2):234-251. doi: 10.1123/mc.2020-0008.
- Individual participant dataSharing planned: No. Participants consented to data use only for this specific study under approved protocols. Regulations prohibit broad sharing of pseudonymized sensor/video data that could potentially be re-identified (e.g., physical features in GoPro videos, unique gait patterns).
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Thierry Lelard, PhD, HDR study director
Lecturer
Maryne Cozette, PhD, Lecturer study director
Lecturer
Guillaume Léonard, PhD, Lecturer study director
Lecturer
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain expectation conditioning and Gait assesment in people with Pain and Nocebo Effect, run by Universite de Picardie Jules Verne at 2 sites in 2 countries.
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 15 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, 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?
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 Jennifer Burgos-Tirado, M.Sc.A., Ing. (+33 7 71 27 11 35, jennifer.burgos.tirado@u-picardie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of muscle synergies derived by non-negative matrix factorization (time frame: Before intervention, after intervention (10 minutes after cream application)). 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 NCT07251387, which also lists 3 linked publications.
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 11 Jun 2026.