Muscular Synergies and Behavioral Adaptations of Gait in Pain Anticipation (SYAMAPP)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorUniversite de Picardie Jules Verne

About this trial

The purpose of this study is to determine whether the anticipation of pain influences gait control and psychophysiological responses in healthy individuals. Participants will receive a neutral cream described either as potentially painful (experimental group) or inert (control group), and their behavioral and physiological adaptations will be measured during walking tasks.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18-35 years

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pain expectation conditioning

    Other intervention

    Participants receive application of a neutral cream (MEDICAFARM) with verbal and behavioral suggestions that it may cause localized pain. Researchers wear gloves during application and emphasize potential discomfort, stating effects may intensify with movement.

  • Comparator (Control Group)

    Other intervention

    Participants receive identical application of the neutral cream but are informed it is inert and harmless. Researchers apply the cream without gloves and provide neutral instructions.

  • Intervention: Gait

    Other intervention

    Participants undergo assessment procedures including: * Pre- and post-application gait analysis (GAITRite mat, Zebris treadmill) * Physiological monitoring (EMG, HRV, EDA) * Identical questionnaires (BPI, TSK, FACS, PCS, VAS)

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Nocebo Conditioning GroupExperimental treatment 2 interventions
Group B: Control GroupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Walk ratio

Index that quantifies gait adaptations. Measured via GAITRite mat and Zebris treadmill.

Time frame
During intervention (pre/post cream application): for the mat, during a 2-minute free walk and for the treadmill, during a 5-minute treadmill walk with increases in speed every 30 seconds.

Secondary outcomes

1

ECG/Heart Rate Variability (HRV)

R-R interval variability during walking tasks.

Time frame
During intervention (pre/post cream application): for the mat, during a 2-minute free walk and for the treadmill, during a 5-minute treadmill walk with increases in speed every 30 seconds.
2

Electrodermal Activity (EDA)

Skin conductance during tasks.

Time frame
During intervention (pre/post cream application): for the mat, during a 2-minute free walk and for the treadmill, during a 5-minute treadmill walk with increases in speed every 30 seconds.
3

Pain Catastrophizing (PCS)

Pain Catastrophizing Scale total score (0-52). Users rate 13 statements on a scale from 0 (not at all) to 4 (all the time).

Time frame
Before intervention.
4

Fear-Avoidance Beliefs (FACS)

Fear-Avoidance Components Scale total score (0-100). Users rate 20 statements from 5 (Strongly agree) to 0 (Strongly disagree).

Time frame
Before intervention.

Other outcomes

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