Muscular Synergies and Behavioral Adaptations of Gait in Pain Anticipation (SYAMAPP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pain expectation conditioning, Comparator (Control Group), Intervention: Gait.
- Who it may be relevant to
- Registry conditions: Nocebo Effect, Pain Anticipation. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other 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. - Other 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. - Other 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)
Primary outcome measures
- 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.]
Secondary outcome measures (10)
- 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.]
- 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.]
- Pain Catastrophizing (PCS) [Time frame: Before intervention.]
- Fear-Avoidance Beliefs (FACS) [Time frame: Before intervention.]
- Kinesiophobia (TSK) [Time frame: Before intervention.]
- Pain Severity (BPI) [Time frame: Before intervention.]
- 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.]
- 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.]
- 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.]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
France · 1 center
- Université de Picardie Jules Verne — Amiens
Publications
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT06929559 · IRB00012476-2025-26-03-393