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

Overview

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.

Interventions

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

Primary outcome measures

• Gait complexity [Time frame: 10 days before surgery +/- 3 days]
• Gait complexity [Time frame: Month 3]
• Gait complexity [Time frame: Month 6]

Secondary outcome measures (12)

• Patient reported pain [Time frame: 10 days before surgery +/- 3 days]
• Patient reported pain [Time frame: Month 3]
• Patient reported pain [Time frame: Month 6]
• Apprehension of pain of movement [Time frame: 10 days before surgery +/- 3 days]
• Apprehension of pain of movement [Time frame: Month 3]
• Apprehension of pain of movement [Time frame: Month 6]
• Patient reported quality of life [Time frame: 10 days before surgery +/- 3 days]
• Patient reported quality of life [Time frame: Month 3]
• Patient reported quality of life [Time frame: Month 6]
• Correlation between type of surgery and gait variability [Time frame: 10 days before surgery +/- 3 days]
• Correlation between type of surgery and gait variability [Time frame: Month 3]
• Correlation between type of surgery and gait variability [Time frame: Month 6]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

France · 2 centers

• CHU Nîmes — Nîmes
• Polyclinique Grand Sud — Nîmes

Identifiers

NCT: NCT05231265 · NIMAO/2020-2/AH-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗