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

Low Back Pain Clinical Trial

— LOBAFRACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05231265
• Other study ID #: NIMAO/2020-2/AH-2
• Status: Recruiting
• Start date: October 16, 2023
• Est. completion date: October 2025

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Alexis Homs
• Phone: 04.66.68.34.59
• Email: alexis.homs[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
France	Polyclinique Grand Sud	Nimes
France	CHU Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait complexity	fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)	10 days before surgery +/- 3 days
Primary	Gait complexity	fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)	Month 3
Primary	Gait complexity	fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)	Month 6
Secondary	Patient reported pain	Visual analog scale (0-100)	10 days before surgery +/- 3 days
Secondary	Patient reported pain	Visual analog scale (0-100)	Month 3
Secondary	Patient reported pain	Visual analog scale (0-100)	Month 6
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Correlation between type of surgery and gait variability	Classified as either arthrodesis or prosthesis	10 days before surgery +/- 3 days
Secondary	Correlation between type of surgery and gait variability	Classified as either arthrodesis or prosthesis	Month 3
Secondary	Correlation between type of surgery and gait variability	Classified as either arthrodesis or prosthesis	Month 6