Effect of Lumbar Surgery on Complexity During a Walking Task in Chronic Low Back Pain

NCT05231265 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Universitaire de Nīmes

Phase

Observational

Started

2023-10-16

Last updated

2026-06-01

Condition(s) studied

Low Back Pain

Investigational drug(s) / intervention(s)

Walking task

Walking task: Treadmill walking task with study of fractal variability (complexity) for 10 minutes.

Study summary

Lumbar surgery is the most common treatment for chronic disabling low back pain with degenerative disc disease. There are few elements to objectively evaluate the improvement of the motor control after surgery and the motor adaptation capacities of the patients.

The impact of lumbar surgery on complexity in this painful context has never been studied. Theoretically, the restriction of mobility imposed by lumbar surgery should limit the subject's adaptive capacities (of one or more lumbar segments) and thus reduce complexity. Nevertheless, improvement in pain intensity levels could allow the patient to find better motor adaptation capacities, necessary for a positive evolution in the long-term.

The aim of this study was to investigate the evolution of gait complexity in chronic low back pain patients pre- and post-surgery. If surgery improves the adaptability of walking through an antalgic benefit exceeding the induced stiffness, the complexity of walking should be superior after surgery.

This is a proof-of-concept study in which the study investigators hypothesize that measuring complexity by fractal analysis during a walking task will show the increase in gait complexity induced by lumbar surgery at 3 and 6 months after surgery.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients with chronic low back pain requiring prosthesis or arthrodesis surgery on one or two levels * Subject affiliated or beneficiary of a health insurance plan. * The patient must have given their free and informed consent Exclusion Criteria: * Patients with organic low back pain (infection, tumor, inflammatory rheumatism) * Patient with a neurological deficit (cauda equina syndrome or motor testing MRC \< 3 on a muscle group of the lower limbs) * Patient who has already undergone lumbar surgery (except single discectomy) * Patient with serious concomitant pathologies * Patients participating in a therapeutic study prohibiting participation in another study * Patient in an exclusion period from a different study * It is impossible to give the subject informed information * Patient is unable to express consent * The patient is under safeguard of justice or state guardianship * Patient is pregnant, parturient or breastfeeding

Primary outcome measure(s)

Gait complexity — 10 days before surgery +/- 3 days
fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)
Gait complexity — Month 3
fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)
Gait complexity — Month 6
fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)

Trial sites (2)

Facility	City	Region	Status
CHU Nîmes	Nîmes	France	Recruiting
Polyclinique Grand Sud	Nîmes	France	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05231265 on ClinicalTrials.gov ↗ ← All trials in France