Clinical trial NCT05231265: Effect of Lumbar Surgery on Complexity During a Walking Task in Chronic Low Back Pain
Official title: Effect of Lumbar Surgery on Complexity During a Walking Task in the Chronic Low Back Pain Patient
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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 outcomes:
measure: Gait complexity
timeFrame: 10 days before surgery +/- 3 days
measure: Gait complexity
timeFrame: Month 3
measure: Gait complexity
timeFrame: Month 6
Secondary outcomes:
measure: Patient reported pain
timeFrame: 10 days before surgery +/- 3 days
measure: Patient reported pain
timeFrame: Month 3
measure: Patient reported pain
timeFrame: Month 6
measure: Apprehension of pain of movement
timeFrame: 10 days before surgery +/- 3 days
measure: Apprehension of pain of movement
timeFrame: Month 3
measure: Apprehension of pain of movement
timeFrame: Month 6
measure: Patient reported quality of life
timeFrame: 10 days before surgery +/- 3 days
measure: Patient reported quality of life
timeFrame: Month 3
measure: Patient reported quality of life
timeFrame: Month 6
measure: Correlation between type of surgery and gait variability
timeFrame: 10 days before surgery +/- 3 days
measure: Correlation between type of surgery and gait variability
timeFrame: Month 3
measure: Correlation between type of surgery and gait variability
timeFrame: Month 6
Other outcomes:
Locations:
city: Nimes
country: France
facility: Polyclinique Grand Sud
city: Nîmes
country: France
facility: CHU Nîmes
Study officials:
affiliation: CHU Nimes
name: Alexis Homs
role: PRINCIPAL_INVESTIGATOR
References: