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

2 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

      • Rennes, Francia, 35000
        • University of Rennes 2
        • Sub-investigatore:
          • Mathieu Ménard, PhD
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Nolwenn Fougeron, PhD
        • Sub-investigatore:
          • Diane Haering, PhD
        • Sub-investigatore:
          • Armel Crétual, Professor
        • Sub-investigatore:
          • Olivier Roze, MD
        • Investigatore principale:
          • Emilie Leblong, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

- 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in muscle stiffness of the erector spinae and multifidus muscles between rest and after physical activity
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Ultrasound morphological measurements
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Emilie Leblong, MD, Fondation Saint Helier, 35043 Rennes, France

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2028

Completamento dello studio (Stimato)

1 settembre 2028

Date di iscrizione allo studio

Primo inviato

2 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 settembre 2026

Primo Inserito (Effettivo)

8 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 settembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-A00042-49

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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