Muscular Synergies and Behavioral Adaptations of Gait in Pain Anticipation (SYAMAPP)
NCT ID: NCT06929559
Last Updated: 2025-09-26
Study Results
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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NOT_YET_RECRUITING
NA
34 participants
INTERVENTIONAL
2025-10-01
2028-10-30
Brief Summary
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Detailed Description
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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 0.5 m/s to 4.1 m/s in increments of 0.4 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 three more VAS's are administered: one during the treadmill walking task, at the end of the 1.3 m/s speed recording, another during the free walking task, after half of the completed gait cycles, and a final 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Nocebo Conditioning Group
Participants in this arm will receive the neutral cream with instructions suggesting it may cause pain.
Pain expectation conditioning
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.
Intervention: Gait
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
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.
Comparator (Control Group)
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
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)
Interventions
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Pain expectation conditioning
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)
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
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
35 Years
ALL
Yes
Sponsors
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Universite de Picardie Jules Verne
OTHER
Responsible Party
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Jennifer Burgos Tirado
Researcher - Ph.D student
Principal Investigators
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Thierry Lelard, PhD
Role: STUDY_DIRECTOR
Lecturer
Maryne Cozette, PhD
Role: STUDY_DIRECTOR
Lecturer
Locations
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Université de Picardie Jules Verne
Amiens, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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IRB00012476-2025-26-03-393
Identifier Type: -
Identifier Source: org_study_id
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