NCT07251387

Brief Summary

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.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable pain

Geographic Reach
2 countries

2 active sites

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

September 22, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

September 22, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

Nocebo effectPain anticipationPainGaitMotricityMuscle synergies

Outcome Measures

Primary Outcomes (2)

  • Distribution of muscle synergies derived by non-negative matrix factorization

    Changes in the activation of the muscle synergies during the gait cycle.

    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)

    Before intervention, after intervention (10 minutes after cream application)

Secondary Outcomes (4)

  • Pain Catastrophizing (PCS)

    Before intervention.

  • Tampa Scale for Kinesiophobia (TSK)

    Before intervention.

  • Self-Reported Pain (VAS)

    Before cream application of the cream (pre-intervention) and 10 minutes after cream application (post-intervention).

  • Force reactions

    Before intervention, after intervention (10 minutes after cream application)

Study Arms (2)

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.

Other: Pain expectation conditioningOther: Gait assesment

Control Group

SHAM COMPARATOR

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.

Other: Pain expectation conditioningOther: Gait assesment

Interventions

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.

Control GroupPrior Experience Group

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 GroupPrior Experience Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre de Recherche sur le Vieillissement

Sherbrooke, Canada

Location

Université de Picardie Jules Verne

Amiens, France

Location

Related Publications (3)

  • 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.

    PMID: 34045515BACKGROUND
  • 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.

    PMID: 34145580BACKGROUND
  • 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.

    PMID: 33503586BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thierry Lelard, PhD, HDR

    Lecturer

    STUDY DIRECTOR
  • Maryne Cozette, PhD, Lecturer

    Lecturer

    STUDY DIRECTOR
  • Guillaume Léonard, PhD, Lecturer

    Lecturer

    STUDY DIRECTOR

Central Study Contacts

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

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not aware that a cream applied to them (neutral cream) does not produce any pain.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher - Ph.D student

Study Record Dates

First Submitted

September 22, 2025

First Posted

November 26, 2025

Study Start

January 1, 2026

Primary Completion

February 1, 2026

Study Completion

April 1, 2026

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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).

Locations