Non-specific Chronic Low Back PainE-LBPNCT07806253
Relationships Between Muscle Activity, Soft Tissue Changes, and Movement Strategies in Individuals With Chronic Low Back Pain
A study testing Supervised Progressive Walking Test in people with Non-specific Chronic Low Back Pain, run by University of Rennes 2 at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-specific Chronic Low Back Pain
- What is being tested?
- Supervised Progressive Walking Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 43Show fewer
- 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
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University of Rennes 2
Rennes, 35000
Léo Denouël, PhD Student, +33 (0) 681768024, leo.denouel@univ-rennes2.fr
Armel Crétual, Professor, +33 (0) 290091588, armel.cretual@univ-rennes2.fr
About this study
Official title: 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.
- Conditions
- Non-specific Chronic Low Back Pain
- Being tested
- Supervised Progressive Walking Test
- Keywords
- Non-specific Chronic Low Back Pain, nscLBP, physical activity, walking, muscular activity, muscular stiffness, biomechanical assessment, movement Strategies
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Progressive Walking TestOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-specific Chronic Low Back Pain participants | Experimental | Participants underwent a single assessment session including lumbar muscle ultrasound imaging, functional movement task analysis and a walking test. No therapeutic intervention was administered. Receives: Other: Supervised Progressive Walking Test |
| Asymptomatic participants | Experimental | Participants underwent a single assessment session including lumbar muscle ultrasound imaging, functional movement task analysis and a walking test. No therapeutic intervention was administered. Receives: Other: Supervised Progressive Walking Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measurement of the cross-sectional area and thickness-as determined by ultrasound-of the erector spinae and multifidus muscles at rest.
Measured: Data were collected during the experimental session.
Electromyographic activity
Lumbar muscle activations during three-dimensional lumbar movements and while walking
Measured: Data were collected during the experimental session.
Kinematics
The kinematics of the lumbopelvic-femoral complex (segmental velocity and acceleration, joint angles) during three-dimensional movements and while walking.
Measured: Data were collected during the experimental session.
General data
Age, sex, height, weight, body mass index, and socioeconomic status are recorded.
Measured: Data were collected during the experimental session
Impact, effort, and sensations during the walking experience
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
Measured: Data were collected during the experimental session
Physical function
Patients' physical function is assessed using the Oswestry Disability Index (ODI).
Measured: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Pain intensity and location
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.
Measured: Data were collected during the experimental session
Daily impact of pain
The daily impact of pain (daily activities, work, leisure, anxiety and depression, social life) is assessed using the Dallas Self-Report Questionnaire (DRAD).
Measured: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Quality of life health-related
Health-related quality of life is assessed using the SF-12 questionnaire (SF-12)
Measured: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Physical activity and sedentary behavior
Participants' physical activity and sedentary behavior are assessed using the French version of the Global Physical Activity Questionnaire (GPAQ).
Measured: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Kinesiophobia
Fear of physical injury related to movement is assessed using the Tampa Scale for Kinesiophobia (TSK).
Measured: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Anxiety and depressive disorders
Screening for anxiety and depressive disorders is performed using the Hospital Anxiety and Depression Scale (HAD).
Measured: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Validity of ultrasound measurements
The validity of ultrasound measurements is assessed by the intra-operator repeatability of ultrasound measurements.
Measured: Data were collected during the experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rennes 2
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Léo Denouël, University of Rennes 2
- Investigators
- Emilie Leblong, MD, Principal investigator, Fondation Saint Helier, 35043 Rennes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806253
- Sponsor's protocol ID
- 2026-A00042-49
- Acronym
- E-LBP
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07806253
- Acronym / sponsor ID
- E-LBP / 2026-A00042-49
- Conditions
- Non-specific Chronic Low Back Pain
- Keywords
- Non-specific Chronic Low Back Pain, nscLBP, physical activity, walking, muscular activity, muscular stiffness, biomechanical assessment, movement Strategies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Rennes 2University, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-specific Chronic Low Back Pain participants | Experimental | Other: Supervised Progressive Walking TestParticipants 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 | Experimental | Other: Supervised Progressive Walking TestParticipants underwent a single assessment session including lumbar muscle ultrasound imaging, functional movement task analysis and a walking test. No therapeutic intervention was administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (43 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Progressive Walking TestAfter 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. | Other | Asymptomatic participants, Non-specific Chronic Low Back Pain participants |
Primary outcome
Change in muscle stiffness of the erector spinae and multifidus muscles between rest and after physical activity
Time frame: 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.
13 secondary outcomes
Ultrasound morphological measurements
Time frame: Data were collected during the experimental session.
Electromyographic activity
Time frame: Data were collected during the experimental session.
Kinematics
Time frame: Data were collected during the experimental session.
General data
Time frame: Data were collected during the experimental session
Impact, effort, and sensations during the walking experience
Time frame: Data were collected during the experimental session
Physical function
Time frame: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Pain intensity and location
Time frame: Data were collected during the experimental session
Daily impact of pain
Time frame: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Quality of life health-related
Time frame: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Physical activity and sedentary behavior
Time frame: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Kinesiophobia
Time frame: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Anxiety and depressive disorders
Time frame: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)
Validity of ultrasound measurements
Time frame: Data were collected during the experimental session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
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The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilie Leblong, MD principal investigator
Fondation Saint Helier, 35043 Rennes, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Progressive Walking Test in people with Non-specific Chronic Low Back Pain, run by University of Rennes 2 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 43 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Léo Denouël, PhD Student (+33 (0) 681768024, leo.denouel@univ-rennes2.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle stiffness of the erector spinae and multifidus muscles between rest and after physical activity (time frame: As the study consists of a single session, the time frame is between the pre-walking-test and post-walking-test assessments.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.