NCT07806253

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

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress4%
Sep 2026Sep 2028

Study Start

First participant enrolled

September 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

September 8, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

September 2, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

Non-specific Chronic Low Back PainnscLBPphysical activitywalkingmuscular activitymuscular stiffnessbiomechanical assessmentmovement Strategies

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

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.

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.

Other: Supervised Progressive Walking Test

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.

Asymptomatic participantsNon-specific Chronic Low Back Pain participants

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Emilie Leblong, MD

    Fondation Saint Helier, 35043 Rennes, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Léo Denouël, PhD Student

CONTACT

Armel Crétual, Professor

CONTACT

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

Locations