ClinicalTrials.gg
Not yet recruitingNCT07806253E-LBPUpdated Oct 9, 2026

Relationships Between Muscle Activity, Soft Tissue Changes, and Movement Strategies in Individuals With Chronic Low Back Pain

An interventional study of Supervised Progressive Walking Test in Non-specific Chronic Low Back Pain, sponsored by University of Rennes 2. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by University of Rennes 2 · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 367 studies in Motor Activity with a site in France — 78 open to participants now, 90 under way, none of them phase 3. Motor Activity · France.

Planned enrollment
137th of 269
60 · median 62
Started
2026
with 16 others
No phase
254 of 367
52 open now
Primary completion
2028-09
later than 74 of 89 live
Registered
363rd of 367
by date

Among the 367 studies in Motor Activity with a site in France, this one is the 137th largest by planned enrollment of the 269 interventional ones, is one of 17 that started in 2026, is one of 254 with no phase, reaches primary completion later than 74 of the 89 other live ones, and was the 363rd registered.

By phase

367 studies; the count open now beside each. This study's row is marked.

No phasethis study254 · 52 open
Observational98 · 25 open
Phase 28 · 1 open
Phase 35 · 0 open
Phase 42 · 0 open

By the year they started

First in 1983; this study’s year is marked. 17 started in 2026.

Size and results

Median enrollment 62 across the 269 interventional studies, 98 across the 98 observational. Of the 230 that completed or were terminated, 3 (1%) have results posted.

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02

Study 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.

03

Conditions studied

  • Non-specific Chronic Low Back Pain

Browse trials for

Keywords

  • Non-specific Chronic Low Back Pain
  • nscLBP
  • physical activity
  • walking
  • muscular activity
  • muscular stiffness
  • biomechanical assessment
  • movement Strategies
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria for CNSLBP participants:

  • Adult aged 18 to 65 years (inclusive)
  • Have freely given written
  • 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 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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Supervised Progressive Walking Test

  • Experimental
    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.

    Other: Supervised Progressive Walking Test

Interventions

  • OtherSupervised Progressive Walking Test

    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.

06

What researchers measure

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.

    Time frame: As the study consists of a single session, the time frame is between the pre-walking-test and post-walking-test assessments.

Secondary outcomes

  1. Ultrasound morphological measurements

    Measurement of the cross-sectional area and thickness-as determined by ultrasound-of the erector spinae and multifidus muscles at rest.

    Time frame: Data were collected during the experimental session.

  2. Electromyographic activity

    Lumbar muscle activations during three-dimensional lumbar movements and while walking

    Time frame: Data were collected during the experimental session.

  3. Kinematics

    The kinematics of the lumbopelvic-femoral complex (segmental velocity and acceleration, joint angles) during three-dimensional movements and while walking.

    Time frame: Data were collected during the experimental session.

  4. General data

    Age, sex, height, weight, body mass index, and socioeconomic status are recorded.

    Time frame: Data were collected during the experimental session

  5. 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

    Time frame: Data were collected during the experimental session

  6. Physical function

    Patients' physical function is assessed using the Oswestry Disability Index (ODI).

    Time frame: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)

  7. 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.

    Time frame: Data were collected during the experimental session

  8. 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).

    Time frame: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)

  9. Quality of life health-related

    Health-related quality of life is assessed using the SF-12 questionnaire (SF-12)

    Time frame: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)

  10. Physical activity and sedentary behavior

    Participants' physical activity and sedentary behavior are assessed using the French version of the Global Physical Activity Questionnaire (GPAQ).

    Time frame: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)

  11. Kinesiophobia

    Fear of physical injury related to movement is assessed using the Tampa Scale for Kinesiophobia (TSK).

    Time frame: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)

  12. Anxiety and depressive disorders

    Screening for anxiety and depressive disorders is performed using the Hospital Anxiety and Depression Scale (HAD).

    Time frame: Data from the questionnaire were collected during the experimental session, or shortly before (between 1 and 7 days beforehand)

  13. Validity of ultrasound measurements

    The validity of ultrasound measurements is assessed by the intra-operator repeatability of ultrasound measurements.

    Time frame: Data were collected during the experimental session

07

Study locations

1 site
  • University of Rennes 2
    Rennes, 35000, France
    • Léo Denouël, PhD Student · Contactleo.denouel@univ-rennes2.fr · +33 (0) 681768024
    • Armel Crétual, Professor · Contactarmel.cretual@univ-rennes2.fr · +33 (0) 290091588
    • Mathieu Ménard, PhD · Sub investigator
    • Nolwenn Fougeron, PhD · Sub investigator
    • Diane Haering, PhD · Sub investigator
    • Armel Crétual, Professor · Sub investigator
    • Olivier Roze, MD · Sub investigator
    • Emilie Leblong, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 24 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 8, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2028
CompletionEst.
Sep 2028
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and criteria formatting
1 update, last Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    Minor edits only
    + 2 other changes: verification date and criteria formatting

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07806253
Lead sponsor
University of Rennes 2
Responsible party
Léo Denouël (PhD Student, University of Rennes 2) — Principal investigator
First posted
Sep 8, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Oct 9, 2026

Study contacts

Léo Denouël, PhD Student
Contact
leo.denouel@univ-rennes2.fr
+33 (0) 681768024
Armel Crétual, Professor
Contact
armel.cretual@univ-rennes2.fr
+33 (0) 290091588
Emilie Leblong, MD
principal investigator · Fondation Saint Helier, 35043 Rennes, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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