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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Walking task

• Study Type: Observational
• Enrollment (Estimated): 32

Contacts and Locations

• Study Contact: Name: Alexis Homs; Phone Number: 04.66.68.34.59; Email: alexis.homs@chu-nimes.fr

Study Locations

• France
  • Nîmes, France
    • Recruiting
    • CHU Nîmes
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr
    • Principal Investigator: Alexis Homs
    • Sub-Investigator: Arnaud Dupeyron
    • Sub-Investigator: Pascal Kouyoumdjian
  • Nîmes, France
    • Not yet recruiting
    • Polyclinique Grand Sud
    • Contact: Sébastien Trincat; Email: Sebastien.trincat@gmail.com
    • Principal Investigator: Sebastien.trincat@gmail.com Trincat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic low back pain requiring prosthesis or arthrodesis surgery for their lumbar pathology (surgery on one or two levels) followed at the Nîmes University Hospital or at the Grand Sud Polyclinic.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Low Back Pain	Other: Walking task; Treadmill walking task with study of fractal variability (complexity) for 10 minutes.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported pain	Visual analog scale (0-100)	10 days before surgery +/- 3 days
Patient reported pain	Visual analog scale (0-100)	Month 3
Patient reported pain	Visual analog scale (0-100)	Month 6
Apprehension of pain of movement	Tampa Scale of Kinesiophobia. Score ranging from 17-68. Higher scores denote greater level of kinesiophobia (a score >40 is considered significant kinesiophobia)	10 days before surgery +/- 3 days
Apprehension of pain of movement	Tampa Scale of Kinesiophobia. Score ranging from 17-68. Higher scores denote greater level of kinesiophobia (a score >40 is considered significant kinesiophobia)	Month 3
Apprehension of pain of movement	Tampa Scale of Kinesiophobia. Score ranging from 17-68. Higher scores denote greater level of kinesiophobia (a score >40 is considered significant kinesiophobia)	Month 6
Patient reported quality of life	EuroQol-5 Dimension questionnaire: results generated as 5 digit number corresponding to different aspects of quality of life	10 days before surgery +/- 3 days
Patient reported quality of life	EuroQol-5 Dimension questionnaire: results generated as 5 digit number corresponding to different aspects of quality of life	Month 3
Patient reported quality of life	EuroQol-5 Dimension questionnaire: results generated as 5 digit number corresponding to different aspects of quality of life	Month 6
Correlation between type of surgery and gait variability	Classified as either arthrodesis or prosthesis	10 days before surgery +/- 3 days
Correlation between type of surgery and gait variability	Classified as either arthrodesis or prosthesis	Month 3
Correlation between type of surgery and gait variability	Classified as either arthrodesis or prosthesis	Month 6

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Alexis Homs, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: NIMAO/2020-2/AH-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No