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

NCT06929559 | Not Yet Recruiting

• 1 other identifier: IRB00012476-2025-26-03-393
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nocebo Effect; Pain Anticipation

Keywords

Nocebo effect; Pain anticipation; Pain expectation; Motricity; Gait; Walking; Healthy; Muscle synergies

Outcome Measures

Primary Outcomes (1)

• Walk ratio

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

  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 (10)

• Gait Kinematics: Joint amplitudes

  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.

• ECG/Heart Rate Variability (HRV)

  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.

• Electrodermal Activity (EDA)

  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.

• Pain Catastrophizing (PCS)

  Before intervention.

• Fear-Avoidance Beliefs (FACS)

  Before intervention.

Study Arms (2)

Nocebo Conditioning Group

EXPERIMENTAL

Participants in this arm will receive the neutral cream with instructions suggesting it may cause pain.

Other: Pain expectation conditioning; Other: Intervention: Gait

Control Group

PLACEBO COMPARATOR

Participants receive application of identical neutral cream with verbal and behavioral suggestions that it may cause localized pain, creating a nocebo effect through expectation manipulation.

Other: Comparator (Control Group); Other: Intervention: Gait

Interventions

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.

Nocebo Conditioning Group

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.

Control Group

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)

Control Group; Nocebo Conditioning Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Universite de Picardie Jules Verne: lead

Study Sites (1)

Université de Picardie Jules Verne

Amiens, France

Location

Related Publications (5)

• Sarvestani M, Orakifar N, Mofateh R, Seyedtabib M, Karimi M, Mehravar M. The Association Between Lower Limb Joint Position Sense and Different Aspects of Gait Pattern in Individuals With Bilateral Knee Osteoarthritis. J Appl Biomech. 2025 Jan 3;41(2):107-116. doi: 10.1123/jab.2024-0207. Print 2025 Apr 1.

  PMID: 39753124 BACKGROUND

• Bogen B, Moe-Nilssen R, Ranhoff AH, Aaslund MK. The walk ratio: Investigation of invariance across walking conditions and gender in community-dwelling older people. Gait Posture. 2018 Mar;61:479-482. doi: 10.1016/j.gaitpost.2018.02.019. Epub 2018 Feb 21.

  PMID: 29494821 BACKGROUND

• 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: 34045515 BACKGROUND

• Karos K, Meulders A, Gatzounis R, Seelen HAM, Geers RPG, Vlaeyen JWS. Fear of pain changes movement: Motor behaviour following the acquisition of pain-related fear. Eur J Pain. 2017 Sep;21(8):1432-1442. doi: 10.1002/ejp.1044. Epub 2017 Apr 25.

  PMID: 28444803 BACKGROUND

• 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: 34145580 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Thierry Lelard, PhD

  Lecturer

  STUDY DIRECTOR

• Maryne Cozette, PhD

  Lecturer

  STUDY DIRECTOR

Central Study Contacts

Jennifer Burgos-Tirado, Master

CONTACT

07 71 27 11 35; jennifer.burgos.tirado@u-picardie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: 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: March 27, 2025
• First Posted: April 16, 2025
• Study Start: October 1, 2025
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)