NCT05231265

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
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 Progress77%
Oct 2023Apr 2027

First Submitted

Initial submission to the registry

January 28, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

3.5 years

First QC Date

January 28, 2022

Last Update Submit

May 28, 2026

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (12)

  • Patient reported pain

    10 days before surgery +/- 3 days

  • Patient reported pain

    Month 3

  • Patient reported pain

    Month 6

  • Apprehension of pain of movement

    10 days before surgery +/- 3 days

  • Apprehension of pain of movement

    Month 3

  • +7 more secondary outcomes

Study Arms (1)

Patients with Low Back Pain

Other: Walking task

Interventions

Walking taskOTHER

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

Patients with Low Back Pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Nîmes

Nîmes, France

RECRUITING

Polyclinique Grand Sud

Nîmes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alexis Homs

    CHU Nimes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis Homs

CONTACT

04.66.68.34.59alexis.homs@chu-nimes.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 9, 2022

Study Start

October 16, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

June 1, 2026

Record last verified: 2026-05

Locations

FR(2)