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
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2026
CompletedFirst Submitted
Initial submission to the registry
September 2, 2026
CompletedFirst Posted
Study publicly available on registry
September 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
September 8, 2026
August 1, 2026
2 years
September 2, 2026
September 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in muscle stiffness of the erector spinae and multifidus muscles between rest and after physical activity
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.
Secondary Outcomes (13)
Ultrasound morphological measurements
Data were collected during the experimental session.
Electromyographic activity
Data were collected during the experimental session.
Kinematics
Data were collected during the experimental session.
General data
Data were collected during the experimental session
Impact, effort, and sensations during the walking experience
Data were collected during the experimental session
- +8 more secondary outcomes
Study Arms (2)
Non-specific Chronic Low Back Pain participants
EXPERIMENTALParticipants underwent a single assessment session including lumbar muscle ultrasound imaging, functional movement task analysis and a walking test. No therapeutic intervention was administered.
Asymptomatic participants
EXPERIMENTALParticipants underwent a single assessment session including lumbar muscle ultrasound imaging, functional movement task analysis and a walking test. No therapeutic intervention was administered.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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:
- 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.
- 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
- 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:
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rennes 2
Rennes, 35000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emilie Leblong, MD
Fondation Saint Helier, 35043 Rennes, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
September 2, 2026
First Posted
September 8, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
September 8, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share