Muscle Synergies in Pain and Pain Anticipation

NCT ID: NCT07251387

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-04-01

Brief Summary

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This study investigates how the anticipation of pain affects muscle synergies. Two groups will be compared: an experimental group, who first experience actual pain from capsaicin cream and are then presented with a harmless cream deceptively labeled as capsaicin, against a control group, who are presented with a harmless cream labeled as potentially painful, without any prior painful experience. The changes in muscle synergies will be measured during walking tasks.

Detailed Description

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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 one of two groups based on their screening responses:

1. Experimental Group ("Prior Experience"): Individuals who report a prior painful experience with capsaicin cream.
2. Control Group ("No Prior Experience"): Individuals who report no prior experience with capsaicin cream.

All participants will take part in a single experimental session. Both groups will receive identical negative verbal suggestions indicating that a neutral, harmless cream is a potent capsaicin formulation likely to cause pain.

Participants will complete 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).

The neutral 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 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 and ground reaction forces.

Conditions

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Pain Nocebo Effect Pain Anticipation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants are not aware that a cream applied to them (neutral cream) does not produce any pain.

Study Groups

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Prior Experience Group

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.

Group Type EXPERIMENTAL

Pain expectation conditioning

Intervention Type OTHER

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 assesment

Intervention Type OTHER

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.

Control Group

Pariticpants in this arm have never experienced capsaicin cream before and will be given a neutral cream. They will be told that the cream contains capsaicin and will cause pain.

Group Type SHAM_COMPARATOR

Pain expectation conditioning

Intervention Type OTHER

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 assesment

Intervention Type OTHER

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.

Interventions

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Pain expectation conditioning

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.

Intervention Type OTHER

Gait assesment

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mitacs

INDUSTRY

Sponsor Role collaborator

Universite de Picardie Jules Verne

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Burgos Tirado

Researcher - Ph.D student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thierry Lelard, PhD, HDR

Role: STUDY_DIRECTOR

Lecturer

Maryne Cozette, PhD, Lecturer

Role: STUDY_DIRECTOR

Lecturer

Guillaume Léonard, PhD, Lecturer

Role: STUDY_DIRECTOR

Lecturer

Locations

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Centre de Recherche sur le Vieillissement

Sherbrooke, , Canada

Site Status

Université de Picardie Jules Verne

Amiens, , France

Site Status

Countries

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Canada France

Central Contacts

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Jennifer Burgos-Tirado, M.Sc.A., Ing.

Role: CONTACT

+33 7 71 27 11 35

Facility Contacts

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Guillaume Léonard, PhD

Role: primary

819-829-7131

Said Ahmaidi

Role: primary

+33 3 22 82 74 41

References

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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.

Reference Type BACKGROUND
PMID: 34045515 (View on PubMed)

Horvath 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.

Reference Type BACKGROUND
PMID: 34145580 (View on PubMed)

Escalona 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.

Reference Type BACKGROUND
PMID: 33503586 (View on PubMed)

Other Identifiers

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2025-5551-1H

Identifier Type: -

Identifier Source: org_study_id

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