- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Léo Denouël, PhD Student
- Numer telefonu: +33 (0) 681768024
- E-mail: leo.denouel@univ-rennes2.fr
Kopia zapasowa kontaktu do badania
- Nazwa: Armel Crétual, Professor
- Numer telefonu: +33 (0) 290091588
- E-mail: armel.cretual@univ-rennes2.fr
Lokalizacje studiów
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Rennes, Francja, 35000
- University of Rennes 2
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Pod-śledczy:
- Mathieu Ménard, PhD
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Kontakt:
- Léo Denouël, PhD Student
- Numer telefonu: +33 (0) 681768024
- E-mail: leo.denouel@univ-rennes2.fr
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Kontakt:
- Armel Crétual, Professor
- Numer telefonu: +33 (0) 290091588
- E-mail: armel.cretual@univ-rennes2.fr
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Pod-śledczy:
- Nolwenn Fougeron, PhD
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Pod-śledczy:
- Diane Haering, PhD
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Pod-śledczy:
- Armel Crétual, Professor
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Pod-śledczy:
- Olivier Roze, MD
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Główny śledczy:
- Emilie Leblong, MD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
- 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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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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.
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Eksperymentalny: 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in muscle stiffness of the erector spinae and multifidus muscles between rest and after physical activity
Ramy czasowe: As the study consists of a single session, the time frame is between the pre-walking-test and post-walking-test assessments.
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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.
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As the study consists of a single session, the time frame is between the pre-walking-test and post-walking-test assessments.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Ultrasound morphological measurements
Ramy czasowe: Data were collected during the experimental session.
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Measurement of the cross-sectional area and thickness-as determined by ultrasound-of the erector spinae and multifidus muscles at rest.
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Data were collected during the experimental session.
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Electromyographic activity
Ramy czasowe: Data were collected during the experimental session.
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Lumbar muscle activations during three-dimensional lumbar movements and while walking
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Data were collected during the experimental session.
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Kinematics
Ramy czasowe: Data were collected during the experimental session.
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The kinematics of the lumbopelvic-femoral complex (segmental velocity and acceleration, joint angles) during three-dimensional movements and while walking.
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Data were collected during the experimental session.
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General data
Ramy czasowe: Data were collected during the experimental session
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Age, sex, height, weight, body mass index, and socioeconomic status are recorded.
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Data were collected during the experimental session
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Impact, effort, and sensations during the walking experience
Ramy czasowe: Data were collected during the experimental session
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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
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Physical function
Ramy czasowe: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
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Patients' physical function is assessed using the Oswestry Disability Index (ODI).
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Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
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Pain intensity and location
Ramy czasowe: Data were collected during the experimental session
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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.
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Data were collected during the experimental session
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Daily impact of pain
Ramy czasowe: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
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The daily impact of pain (daily activities, work, leisure, anxiety and depression, social life) is assessed using the Dallas Self-Report Questionnaire (DRAD).
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Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
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Quality of life health-related
Ramy czasowe: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
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Health-related quality of life is assessed using the SF-12 questionnaire (SF-12)
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Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
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Physical activity and sedentary behavior
Ramy czasowe: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
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Participants' physical activity and sedentary behavior are assessed using the French version of the Global Physical Activity Questionnaire (GPAQ).
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Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
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Kinesiophobia
Ramy czasowe: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
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Fear of physical injury related to movement is assessed using the Tampa Scale for Kinesiophobia (TSK).
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Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
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Anxiety and depressive disorders
Ramy czasowe: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
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Screening for anxiety and depressive disorders is performed using the Hospital Anxiety and Depression Scale (HAD).
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Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
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Validity of ultrasound measurements
Ramy czasowe: Data were collected during the experimental session
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The validity of ultrasound measurements is assessed by the intra-operator repeatability of ultrasound measurements.
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Data were collected during the experimental session
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Emilie Leblong, MD, Fondation Saint Helier, 35043 Rennes, France
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2026-A00042-49
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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