- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07806253
Relationships Between Muscle Activity, Soft Tissue Changes, and Movement Strategies in Individuals With Chronic Low Back Pain (E-LBP)
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
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Léo Denouël, PhD Student
- Telefonní číslo: +33 (0) 681768024
- E-mail: leo.denouel@univ-rennes2.fr
Studijní záloha kontaktů
- Jméno: Armel Crétual, Professor
- Telefonní číslo: +33 (0) 290091588
- E-mail: armel.cretual@univ-rennes2.fr
Studijní místa
-
-
-
Rennes, Francie, 35000
- University of Rennes 2
-
Dílčí vyšetřovatel:
- Mathieu Ménard, PhD
-
Kontakt:
- Léo Denouël, PhD Student
- Telefonní číslo: +33 (0) 681768024
- E-mail: leo.denouel@univ-rennes2.fr
-
Kontakt:
- Armel Crétual, Professor
- Telefonní číslo: +33 (0) 290091588
- E-mail: armel.cretual@univ-rennes2.fr
-
Dílčí vyšetřovatel:
- Nolwenn Fougeron, PhD
-
Dílčí vyšetřovatel:
- Diane Haering, PhD
-
Dílčí vyšetřovatel:
- Armel Crétual, Professor
-
Dílčí vyšetřovatel:
- Olivier Roze, MD
-
Vrchní vyšetřovatel:
- Emilie Leblong, MD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in muscle stiffness of the erector spinae and multifidus muscles between rest and after physical activity
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Ultrasound morphological measurements
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Emilie Leblong, MD, Fondation Saint Helier, 35043 Rennes, France
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026-A00042-49
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .