Muscle Synergies in Pain and Pain Anticipation

November 24, 2025 updated by: Jennifer Burgos Tirado, Universite de Picardie Jules Verne

Test-retest Fidelity of a Tool for Calculation of Muscle Synergies

This study investigates how the anticipation of pain affects muscle synergies. Two groups will be compared: an experimental group, who first experience actual pain from capsaicin cream and are then presented with a harmless cream deceptively labeled as capsaicin, against a control group, who are presented with a harmless cream labeled as potentially painful, without any prior painful experience. The changes in muscle synergies will be measured during walking tasks.

Study Overview

Status

Not yet recruiting

Detailed Description

Participants will be recruited through university announcements. Eligibility will be determined by a screening process that assesses prior experience with capsaicin cream. Healthy adults aged 18-35 who meet the inclusion criteria will be enrolled and assigned to one of two groups based on their screening responses:

  1. Experimental Group ("Prior Experience"): Individuals who report a prior painful experience with capsaicin cream.
  2. Control Group ("No Prior Experience"): Individuals who report no prior experience with capsaicin cream.

All participants will take part in a single experimental session. Both groups will receive identical negative verbal suggestions indicating that a neutral, harmless cream is a potent capsaicin formulation likely to cause pain.

Participants will complete a walking assessment on a treadmill. The speed will be incrementally increased from 0.8 m/s to 1.1 m/s. Throughout this task, muscle activity will be recorded via electromyography (EMG), and ground reaction forces will be captured by force platforms embedded in the treadmill.

Following the initial walk, participants will complete a set of standardized questionnaires to establish baseline scores for pain perception (Visual Analog Scale, VAS), fear of movement (Tampa Scale of Kinesiophobia, TSK), and pain catastrophizing (Pain Catastrophizing Scale, PCS).

The neutral cream will be applied to the knee, specifically in the area between the lateral epicondyles of the femur, in a 4 cm wide band. Participants will immediately fill out the VAS to report any pain sensations. The walking assessment is repeated, measuring the same physiological signals (EMG and ground reaction forces).

The primary objective is to determine whether a prior painful experience with capsaicin causes individuals to generalize that pain memory to a neutral sensation, leading to different outcomes than in those who only have a negative expectation. We will specifically investigate the magnitude of this effect on muscle synergies and ground reaction forces.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 18-35 years old
  • 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 (prior intervention) 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prior Experience Group
Participants in this arm have experienced capsaicin cream before and will be given a neutral cream. They will be told that the cream contains capsaicin and will cause pain.
Participants receive a neutral cream with no real harmful effects with verbal and behavioral suggestions that it may cause localized pain. Researchers wear gloves during application and emphasize the potential discomfort, stating effects may intensify with movement.
Gait will be assessed both before and after cream application. Each assessment will consist of walking on a treadmill at varying speeds while physiological data (EMG) is recorded. Identical questionnaires (VAS, TAMPA, and PCS) will be administered immediately following the first gait assessment.
Sham Comparator: Control Group
Pariticpants in this arm have never experienced capsaicin cream before and will be given a neutral cream. They will be told that the cream contains capsaicin and will cause pain.
Participants receive a neutral cream with no real harmful effects with verbal and behavioral suggestions that it may cause localized pain. Researchers wear gloves during application and emphasize the potential discomfort, stating effects may intensify with movement.
Gait will be assessed both before and after cream application. Each assessment will consist of walking on a treadmill at varying speeds while physiological data (EMG) is recorded. Identical questionnaires (VAS, TAMPA, and PCS) will be administered immediately following the first gait assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of muscle synergies derived by non-negative matrix factorization
Time Frame: Before intervention, after intervention (10 minutes after cream application)
Changes in the activation of the muscle synergies during the gait cycle.
Before intervention, after intervention (10 minutes after cream application)
Changes in Muscle Synergy Composition derived by non-negative matrix factorization.
Time Frame: Before intervention, after intervention (10 minutes after cream application)
Changes in the composition of muscle synergies (i.e., the individuals muscles that comform one muscle synergy)
Before intervention, after intervention (10 minutes after cream application)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Before intervention.
Tampa Scale for 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).
Before intervention.
Self-Reported Pain (VAS)
Time Frame: Before cream application of the cream (pre-intervention) and 10 minutes after cream application (post-intervention).
Visual Analog Scale (0-100 mm) for immediate pain intensity, where 0 = "No pain" and 100 = "Worst pain imaginable."
Before cream application of the cream (pre-intervention) and 10 minutes after cream application (post-intervention).
Force reactions
Time Frame: Before intervention, after intervention (10 minutes after cream application)
Ground reaction forces obtained by the instrumented treadmill.
Before intervention, after intervention (10 minutes after cream application)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Thierry Lelard, PhD, HDR, lecturer
  • Study Director: Maryne Cozette, PhD, Lecturer, lecturer
  • Study Director: Guillaume Léonard, PhD, Lecturer, lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants consented to data use only for this specific study under approved protocols.

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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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