Assessment of the Evolution of Lumbar Spine Movement Fluidity Using Xsens Inertial Sensors in Subjects With Chronic Low Back Pain Before and After Rehabilitation

NCT07327554 | Recruiting

• 2 other identifiers: RECHMPL25_03102025-A02160-49
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain, defined as pain located between the thoracolumbar junction and the lower gluteal fold, becomes chronic in 8% of patients. As the leading cause of disability worldwide, it has major individual and medico-economic consequences. Three-dimensional biomechanical analysis allows exploration of movement alterations related to low back pain. Although several parameters have already been studied (maximum joint range of motion (ROM), lumbopelvic rhythm, movement variability, gait), no consistent kinematic profile has emerged. Movement fluidity, assessed by the presence of jerks (brief movement disturbances), remains under-described despite its relevance in evaluating movement quality. Invistigators hypothesize that lumbar spine movement fluidity during flexion improves after a rehabilitation program and correlates with clinical response. This project stands out by exploring a rarely studied parameter (movement fluidity) and integrating it as a potential indicator for rehabilitation monitoring.

Conditions

Low Back Pain

Keywords

Low back pain; kinematic; jerk; instability catch; aberrant movement patterns

Outcome Measures

Primary Outcomes (1)

• Correlation between the evolution of trunk flexion movement fluidity and the evolution of disability before and after rehabilitation program

  Movement velocity will be measured during flexion using Xsens inertial measurement units (head, T8, L1, L4, S1). Velocity profiles will identify acceleration and deceleration phases. Movement fluidity will be quantified by a normalized jerk metric: the count of local minima and maxima on the angular velocity curve divided by flexion/extension duration (peaks/s). This normalization accounts for variations in movement speed between individuals and measurement sessions, providing a standardized measure of movement smoothness where lower values indicate more fluid motion. Disability will be measured by the change in the score of Oswestry Disability Index (ODI) questionary between the first and last day of rehabilitation. The ODI questionary contains ten topics concerning intensity of pain and activities of daily life. Each question is scored on a scale of 0-5 where zero indicates the least amount of disability and 5 indicating most severe disability. The ODI scale range from 0 to 100

  2 weeks

Secondary Outcomes (16)

• Changes in range of motion (ROM) between the first and last day of rehabilitation program

  2 weeks

• Changes in maximum angular velocity between the first and last day of rehabilitation program

  2 weeks

• Changes in lumbopelvic rhythm between the first and last day of rehabilitation program

  2 weeks

• Changes in functional disability between the first and last day of rehabilitation program

  2 weeks

• Changes in pain between the first and last day of rehabilitation program

  2 weeks

Study Arms (1)

Compare Movement Fluidity Before and After Rehabilitation

EXPERIMENTAL

Evolution of Movement Fluidity Before and After Rehabilitation in patients with chronic low back pain

Device: X-sens sensor

Interventions

X-sens sensor DEVICE

kinematic movement measurement using 5 Xsens inertial sensors (Awinda) placed on the head, thoracic vertebrae (T8), lumbar vertebrae (L1, L4), and sacrum (S1), before and after the rehabilitation program (ten working days). Movement will be measured during standardized tasks including 3 lumbar spine flexions and 3 right and left lumbar rotations. Movements will be recorded by the sensors at a frequency of 100 Hz.

Compare Movement Fluidity Before and After Rehabilitation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years inclusive
• BMI between 18-30 kg/m²
• Chronic low back pain lasting more than three months
• Rehabilitation care in the Physical Medicine and Rehabilitation Department of Montpellier University Hospital

You may not qualify if:

• Sciatica episode within the last three months
• Traumatic, tumoral, or infectious cause of low back pain
• History of spinal, pelvic, or hip fracture
• Inflammatory rheumatism
• Lumbar arthrodesis
• Severe scoliosis
• Subject with a legal protection measure (guardianship, curatorship)
• Subject under legal protection
• Subject not affiliated to a social security system or not benefiting from such a system
• Absence of informed written consent
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Fasciculation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Nervous System Diseases

Study Officials

• Isabel TAVARES, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel TAVARES, MD

CONTACT

0467338717; i-tavaresfigueiredo@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 8, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)