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NCT Number: NCT06929559

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de Picardie Jules Verne

Amiens, France

Location status: Recruiting

Location contact

Thierry Lelard, Lecturer

PRINCIPAL_INVESTIGATOR

UFR STAPS

CONTACT

[email protected]

03 22 82 74 41

About this study

Pain anticipation can significantly alter motor behavior and physiological responses, even in the absence of actual pain. While previous research has established that conditioned expectations can modify gait patterns, muscle activation, and autonomic responses, the specific locomotor adaptations triggered by pain anticipation in healthy individuals remain insufficiently understood. This study examines how manipulating expectations about a neutral cream influences gait control and psychophysiological markers during walking tasks.

Participants will be recruited through university announcements including posters and emails, with eligibility determined via an online screening questionnaire and verbal confirmation the day of the experience. Healthy adults aged 18-35 who meet the inclusion criteria will participate in a single 90-minute experimental session. Random assignment will place participants into either an experimental group, where they receive the neutral cream with verbal suggestions that it may cause localized pain, or a control group that receives identical application with neutral instructions.

The experimental protocol consists of two primary walking assessments conducted both before and after cream application. First, participants perform free walking trials on a GAITRite mat to measure baseline spatiotemporal parameters including walking speed, cadence, and step length at a comfortable speed until completion of 30 gait cycles. Second, treadmill walking and running trials using a Zebris system evaluate gait transitions through incremental speed changes from 0.8 m/s to 1.3 m/s in increments of 0.1 m/s with 10 second familiarisation time in-between measurements. Both walking tasks are recorded using GoPro cameras to subsequent analysis of changes in joint amplitudes. Throughout these tasks, physiological monitoring captures muscle activity via surface EMG, cardiac responses through ECG and heart rate variability measurements, and electrodermal activity as an indicator of autonomic arousal.

Following the first movement assessments and before the application of the cream, participants complete standardized questionnaires evaluating pain perception using the Brief Pain Inventory and visual analog scales (VAS), fear of movement through the Tampa Scale of Kinesiophobia and Fear-Avoidance Components Scale, and pain catastrophizing via the Pain Catastrophizing Scale.

The cream is applied at the level of the knee, between the two lateral epicondyles of the femur with a 4 cm width, and another VAS is filled in after application. The walking tasks are repeated, measuring the same physiological signs and a final VAS is administered one at the end of the protocol.

The primary outcome measure focuses on changes in the walk ratio, calculated as step length divided by cadence, while secondary outcomes examine alterations in kinematic patterns, muscle activation strategies, and autonomic nervous system responses.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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 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

Treatment and study plan

Pain expectation conditioning

Other

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

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

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)

Primary outcomes

  1. Walk ratio

    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.

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

Secondary outcomes

  1. ECG/Heart Rate Variability (HRV)

    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.

    R-R interval variability during walking tasks.

  2. Electrodermal Activity (EDA)

    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.

    Skin conductance during tasks.

  3. Pain Catastrophizing (PCS)

    Time frame: Before intervention.

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

  4. Fear-Avoidance Beliefs (FACS)

    Time frame: Before intervention.

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

  5. Kinesiophobia (TSK)

    Time frame: Before intervention.

    Tampa Scale of Kinesiophobia total score (17-68). Users rate 17 statements in a scale from 1 (Strongly disagree) to 4 (Strongly agree).

  6. Pain Severity (BPI)

    Time frame: Before intervention.

    The Brief Pain Inventory (Short Form) (BPI-SF) measures pain using three key scales: the Pain Severity Scale (ranging from 0 = "No pain" to 10 = "Pain as bad as you can imagine"), which assesses worst, least, average, and current pain over 24 hours; the Pain Interference Scale (0 = "Does not interfere" to 10 = "Completely interferes"), evaluating how pain affects daily activities like mood, work, and sleep; and the Pain Relief Scale (0% = "No relief" to 100% = "Complete relief"), indicating the effectiveness of pain treatments.

  7. Self-Reported Pain (VAS)

    Time frame: 1 and 2. before and after application of the cream (intervention); 3. During the treadmill task: upon finishing the 1.3 m/s speed recording; 4. During the free-walking task: at half of the gait cycles; 5. Upon finishing all tasks.

    Visual Analog Scale (0-100 mm) for immediate pain intensity, where 0 = "No pain" and 100 = "Worst pain imaginable."

  8. Gait Variability Index

    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.

    Step-to-step variability in stride time/length (coefficient of variation, %) derived from GAITRite/Zebris data.

  9. Gait Symmetry Index

    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.

    Inter-limb asymmetry ratio (affected/unaffected side) for step length, stance time, and ground reaction forces (Zebris treadmill).

  10. Muscle synergies

    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

    Electromyographic analysis of lower-limb muscle coordination during walking using non-negative matrix factorisation.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Burgos-Tirado, Master

CONTACT

[email protected]

07 71 27 11 35

Sponsors and collaborators

Lead sponsor

Universite de Picardie Jules Verne

Other

Registry information

Acronym: SYAMAPP

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Apr 16, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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