AzTrials
AzTrials

Nocebo EffectSYAMAPPNCT06929559

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

A study testing Pain expectation conditioning and Intervention: Gait in people with Nocebo Effect and Pain Anticipation, run by Universite de Picardie Jules Verne at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Nocebo Effect, Pain Anticipation
What is being tested?
Pain expectation conditioning and Intervention: Gait
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteFrance
Study dates
1 Jan 2026to 30 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer Burgos-Tirado, Master contact

07 71 27 11 35

jennifer.burgos.tirado@u-picardie.fr

France1 site, 1 recruiting
  • Université de Picardie Jules Verne

    Amiens

    UFR STAPS, 03 22 82 74 41, said.ahmaidi@u-picardie.fr

    Thierry Lelard, Lecturer

    Recruiting

Other trials in France

About this study

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.

Read the 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.

Being tested
Pain expectation conditioning, Comparator (Control Group), Intervention: Gait
Keywords
Nocebo effect, Pain anticipation, Pain expectation, Motricity, Gait, Walking, Healthy, Muscle synergies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain expectation conditioningOther

    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: GaitOther

    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)
Study groups in NCT06929559
Study groupRoleWhat they receive
Nocebo Conditioning GroupExperimentalParticipants in this arm will receive the neutral cream with instructions suggesting it may cause pain.
Receives: Other: Pain expectation conditioning; Other: Intervention: Gait
Control GroupPlacebo comparatorParticipants receive application of identical neutral cream with verbal and behavioral suggestions that it may cause localized pain, creating a nocebo effect through expectation manipulation.
Receives: Other: Comparator (Control Group); Other: Intervention: Gait

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Walk ratio

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

    Measured: 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)
  1. ECG/Heart Rate Variability (HRV)

    R-R interval variability during walking tasks.

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: Before intervention.

  5. Kinesiophobia (TSK)

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

    Measured: Before intervention.

  6. Pain Severity (BPI)

    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.

    Measured: Before intervention.

  7. Self-Reported Pain (VAS)

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

    Measured: 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.

  8. Gait Variability Index

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

    Measured: 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.

  9. Gait Symmetry Index

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

    Measured: 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.

  10. Muscle synergies

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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2025
  2. Study start1 Jan 2026
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06929559
Sponsor's protocol ID
IRB00012476-2025-26-03-393
Acronym
SYAMAPP
Status last verified
Jun 2026
First submitted
27 Mar 2025
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Participants consented to data use only for this specific study under CERSTAPS-approved protocols. French and EU GDPR regulations prohibit broad sharing of pseudonymized sensor/video data that could potentially be re-identified (e.g., physical features in GoPro videos, unique gait patterns).

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 34145580

Questions about this trial

What is this clinical trial studying?

A study testing Pain expectation conditioning and Intervention: Gait in people with Nocebo Effect and Pain Anticipation, run by Universite de Picardie Jules Verne at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Burgos-Tirado, Master (07 71 27 11 35, jennifer.burgos.tirado@u-picardie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06929559, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in