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Relationships Between Muscle Activity, Soft Tissue Changes, and Movement Strategies in Individuals With Chronic Low Back Pain (E-LBP)

2 septembre 2026 mis à jour par: Léo Denouël, University of Rennes 2

Study of the Relationships Between Muscle Activity, Soft Tissue Changes, and Movement Strategies in Individuals With Chronic Low Back Pain, in Order to Support Their Return to Sport and Physical Activity

This study aims to explore, in patients with chronic non-specific low back pain (cnsLBP), the relationships between lumbar muscle activity, structural and morphological characteristics of the paraspinal muscles, and movement strategies, during a functional, ecological task: walking. To do this, we will compare a group of cnsLBP patients with a group of asymptomatic subjects, combining several types of measurements taken at different walking intensities: spinal kinematics (movement strategies), electromyographic activity of the lumbar muscles, and structural parameters of the paraspinal muscles (stiffness and thickness). The objective is twofold: first, to identify any significant differences between cnsLBP patients and healthy subjects on these combined parameters; second, to explore the interactions between these three dimensions (muscle activity, muscle structure, movement strategy) in order to better understand their relationships with pain and with how CNSLBP functions during physical activity. This multidimensional, ecological approach could also help identify subgroups within the cnsLBP population, reflecting the clinical heterogeneity already documented in the literature. Ultimately, the expected results will contribute to a better understanding of the biomechanical and neuromuscular mechanisms involved during physical activity in these patients, and will provide objective elements to help individualize physical activity recommendations according to each patient's profile.

Aperçu de l'étude

Statut

Pas encore de recrutement

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

      • Rennes, France, 35000
        • University of Rennes 2
        • Sous-enquêteur:
          • Mathieu Ménard, PhD
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • Nolwenn Fougeron, PhD
        • Sous-enquêteur:
          • Diane Haering, PhD
        • Sous-enquêteur:
          • Armel Crétual, Professor
        • Sous-enquêteur:
          • Olivier Roze, MD
        • Chercheur principal:
          • Emilie Leblong, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

- Inclusion criteria for CNSLBP participants

Adult aged 18 to 65 years (inclusive) Have freely given written informed consent Present with pain located between the thoracolumbar junction and the inferior gluteal fold, with or without pain in one or both legs This pain must have been present for more than 12 weeks, on a daily or near-daily basis (at least 4 days out of 7) Participants must not be undergoing any treatment, or must have been on a stable analgesic treatment for at least 2 weeks prior to inclusion in the study Must not have performed, in the 72 hours preceding participation in the study, any unusual intense physical activity (e.g., carrying a heavy load (> 25 kg), sporting activity) likely to transiently alter muscle activity or the mechanical properties of the tissues studied

- Non-inclusion criteria for CNSLBP participants

Known contraindications or limitations to walking Cardiovascular risk factors (uncontrolled high blood pressure, poorly controlled diabetes or diabetes with complications, severe untreated dyslipidemia), or heart disease contraindicating physical activity Ongoing litigation following a workplace accident

Any form of specific low back pain, with an identified cause or secondary to an underlying condition, including in particular:

Pain related to a cancer diagnosis Spinal cord or cauda equina symptoms (pyramidal signs, coordination disorders, motor or sensory deficits, sphincter disorders, etc.) Pain following an infection (night sweats, fever, chills, intravenous drug abuse, immunodeficiency, recent surgery, urinary or skin infection, etc.) Recent or pathological fractures (road traffic accidents, history of osteoporosis, chronic corticosteroid use, advanced age, unexplained weight loss, fatigue, history of cancer, etc.) Inflammatory rheumatism (ankylosing spondylitis, rheumatoid arthritis, or other rheumatic diseases) Vascular problems (cold feet, diminished peripheral arterial pulse, etc.) Disabling radicular irradiation, at the investigator's discretion Participants must not have undergone an intensive rehabilitation program within the last 3 months, nor received physiotherapy, manual therapy, acupuncture, or any other type of manual medicine or bodywork treatment outside their usual care, within the 4 weeks preceding inclusion Severe, unstabilized psychiatric condition Person presenting with a pathology or orthopedic disorder affecting locomotion Recent spinal surgery (< 3 months before the inclusion visit) Systemic corticosteroid use, or corticosteroid injection at the lumbar spine, within the last 3 months Muscle relaxant use in the week preceding the experiment

- Inclusion criteria for asymptomatic participants

Adult aged 18 to 65 years (inclusive) Have freely given written informed consent Person presenting no form of low back pain and matching the age and male-to-female ratio characteristics of the CNSLBP group*

In accordance with Article L1121-8-1 of the French Public Health Code, participants must be affiliated to, or beneficiaries of, a social security scheme

To ensure correspondence in terms of age and sex ratio between the CNSLBP group and the healthy group, the frequency of age and gender categories among CNSLBP participants will be used to build, by matching, the group of healthy participants.

- Non-inclusion criteria for asymptomatic participants

Person reporting an ongoing chronic pain complaint or a history of significant chronic pain (≥ 4/10 for at least 6 months) (HAS, 2019) Person unable to perform the walking tasks studied without excessive discomfort or fatigue

- Non-inclusion criteria common to CNSLBP and asymptomatic participants

Known contraindications or limitations to walking Cardiovascular risk factors (uncontrolled high blood pressure, poorly controlled diabetes or diabetes with complications, severe untreated dyslipidemia), or heart disease contraindicating physical activity Severe, unstabilized psychiatric condition Person presenting with a pathology or orthopedic disorder affecting locomotion

(*) Persons referred to in Articles L. 1121-5 to L. 1121-8 and L. 1121-12 of the French Public Health Code:

Pregnant, parturient, or breastfeeding woman Person deprived of liberty by judicial or administrative decision Person hospitalized without consent and not subject to a legal protection measure, and person admitted to a healthcare or social institution for purposes other than research Person subject to an exclusion period for another study Adult subject to a legal protection measure (guardianship, conservatorship, or court protection), or adult unable to express consent and not subject to a protection measure

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Non-specific Chronic Low Back Pain participants
Participants underwent a single assessment session including lumbar muscle ultrasound imaging, functional movement task analysis and a walking test. No therapeutic intervention was administered.
After a warm-up period on the treadmill, the test involves walking, starting at a speed of 3 km/h and increasing the speed by 0.5 km/h every 2 minutes, up to a maximum of 7 km/h. The speed of 7 km/h is a target speed and is not mandatory.
Expérimental: Asymptomatic participants
Participants underwent a single assessment session including lumbar muscle ultrasound imaging, functional movement task analysis and a walking test. No therapeutic intervention was administered.
After a warm-up period on the treadmill, the test involves walking, starting at a speed of 3 km/h and increasing the speed by 0.5 km/h every 2 minutes, up to a maximum of 7 km/h. The speed of 7 km/h is a target speed and is not mandatory.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in muscle stiffness of the erector spinae and multifidus muscles between rest and after physical activity
Délai: As the study consists of a single session, the time frame is between the pre-walking-test and post-walking-test assessments.
Change in muscle stiffness, measured by shear modulus using shear-wave elastography, of the erector spinae and multifidus muscles, between rest and after physical activity.
As the study consists of a single session, the time frame is between the pre-walking-test and post-walking-test assessments.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Ultrasound morphological measurements
Délai: Data were collected during the experimental session.
Measurement of the cross-sectional area and thickness-as determined by ultrasound-of the erector spinae and multifidus muscles at rest.
Data were collected during the experimental session.
Electromyographic activity
Délai: Data were collected during the experimental session.
Lumbar muscle activations during three-dimensional lumbar movements and while walking
Data were collected during the experimental session.
Kinematics
Délai: Data were collected during the experimental session.
The kinematics of the lumbopelvic-femoral complex (segmental velocity and acceleration, joint angles) during three-dimensional movements and while walking.
Data were collected during the experimental session.
General data
Délai: Data were collected during the experimental session
Age, sex, height, weight, body mass index, and socioeconomic status are recorded.
Data were collected during the experimental session
Impact, effort, and sensations during the walking experience
Délai: Data were collected during the experimental session

Intensity of pain experienced, measured using a numerical rating scale at rest and during activity.

Perceived exertion during walking on a treadmill, measured using the Borg CR-10 scale.

Heart rate recorded using a Garmin® HRM heart rate monitor. Time, distance, and speed achieved during the walking task

Data were collected during the experimental session
Physical function
Délai: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Patients' physical function is assessed using the Oswestry Disability Index (ODI).
Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Pain intensity and location
Délai: Data were collected during the experimental session
The intensity of pain experienced by participants on the day of the test, as measured by a numerical rating scale, and the location of the pain, as determined by the Pain Drawing test.
Data were collected during the experimental session
Daily impact of pain
Délai: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
The daily impact of pain (daily activities, work, leisure, anxiety and depression, social life) is assessed using the Dallas Self-Report Questionnaire (DRAD).
Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Quality of life health-related
Délai: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Health-related quality of life is assessed using the SF-12 questionnaire (SF-12)
Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Physical activity and sedentary behavior
Délai: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Participants' physical activity and sedentary behavior are assessed using the French version of the Global Physical Activity Questionnaire (GPAQ).
Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Kinesiophobia
Délai: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Fear of physical injury related to movement is assessed using the Tampa Scale for Kinesiophobia (TSK).
Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Anxiety and depressive disorders
Délai: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Screening for anxiety and depressive disorders is performed using the Hospital Anxiety and Depression Scale (HAD).
Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Validity of ultrasound measurements
Délai: Data were collected during the experimental session
The validity of ultrasound measurements is assessed by the intra-operator repeatability of ultrasound measurements.
Data were collected during the experimental session

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Emilie Leblong, MD, Fondation Saint Helier, 35043 Rennes, France

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 septembre 2028

Achèvement de l'étude (Estimé)

1 septembre 2028

Dates d'inscription aux études

Première soumission

2 septembre 2026

Première soumission répondant aux critères de contrôle qualité

2 septembre 2026

Première publication (Réel)

8 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 septembre 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

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Informations sur les médicaments et les dispositifs, documents d'étude

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