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
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Léo Denouël, PhD Student
- 電話番号:+33 (0) 681768024
- メール:leo.denouel@univ-rennes2.fr
研究連絡先のバックアップ
- 名前:Armel Crétual, Professor
- 電話番号:+33 (0) 290091588
- メール:armel.cretual@univ-rennes2.fr
研究場所
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Rennes、フランス、35000
- University of Rennes 2
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副調査官:
- Mathieu Ménard, PhD
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コンタクト:
- Léo Denouël, PhD Student
- 電話番号:+33 (0) 681768024
- メール:leo.denouel@univ-rennes2.fr
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コンタクト:
- Armel Crétual, Professor
- 電話番号:+33 (0) 290091588
- メール:armel.cretual@univ-rennes2.fr
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副調査官:
- Nolwenn Fougeron, PhD
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副調査官:
- Diane Haering, PhD
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副調査官:
- Armel Crétual, Professor
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副調査官:
- Olivier Roze, MD
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主任研究者:
- Emilie Leblong, MD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
- 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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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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実験的: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in muscle stiffness of the erector spinae and multifidus muscles between rest and after physical activity
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Ultrasound morphological measurements
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
スポンサー
捜査官
- 主任研究者:Emilie Leblong, MD、Fondation Saint Helier, 35043 Rennes, France
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2026-A00042-49
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