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

2. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

      • Rennes, Frankreich, 35000
        • University of Rennes 2
        • Unterermittler:
          • Mathieu Ménard, PhD
        • Kontakt:
        • Kontakt:
        • Unterermittler:
          • Nolwenn Fougeron, PhD
        • Unterermittler:
          • Diane Haering, PhD
        • Unterermittler:
          • Armel Crétual, Professor
        • Unterermittler:
          • Olivier Roze, MD
        • Hauptermittler:
          • Emilie Leblong, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

- 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Experimental: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in muscle stiffness of the erector spinae and multifidus muscles between rest and after physical activity
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Ultrasound morphological measurements
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. September 2028

Studienabschluss (Geschätzt)

1. September 2028

Studienanmeldedaten

Zuerst eingereicht

2. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. September 2026

Zuerst gepostet (Tatsächlich)

8. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. September 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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