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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05231265
Collaborator
(none)
32
2
24
16
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Walking task

Study Design

Study Type:
Observational
Anticipated Enrollment :
32 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Effect of Lumbar Surgery on Complexity During a Walking Task in the Chronic Low Back Pain Patient
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Patients with Low Back Pain

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

Outcome Measures

Primary Outcome Measures

  1. Gait complexity [10 days before surgery +/- 3 days]

    fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)

  2. Gait complexity [Month 3]

    fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)

  3. Gait complexity [Month 6]

    fractal analysis of gait variability: value normally between 0.5 (degraded structure) to 1 (optimal structure)

Secondary Outcome Measures

  1. Patient reported pain [10 days before surgery +/- 3 days]

    Visual analog scale (0-100)

  2. Patient reported pain [Month 3]

    Visual analog scale (0-100)

  3. Patient reported pain [Month 6]

    Visual analog scale (0-100)

  4. Apprehension of pain of movement [10 days before surgery +/- 3 days]

    Tampa Scale of Kinesiophobia. Score ranging from 17-68. Higher scores denote greater level of kinesiophobia (a score >40 is considered significant kinesiophobia)

  5. Apprehension of pain of movement [Month 3]

    Tampa Scale of Kinesiophobia. Score ranging from 17-68. Higher scores denote greater level of kinesiophobia (a score >40 is considered significant kinesiophobia)

  6. Apprehension of pain of movement [Month 6]

    Tampa Scale of Kinesiophobia. Score ranging from 17-68. Higher scores denote greater level of kinesiophobia (a score >40 is considered significant kinesiophobia)

  7. Patient reported quality of life [10 days before surgery +/- 3 days]

    EuroQol-5 Dimension questionnaire: results generated as 5 digit number corresponding to different aspects of quality of life

  8. Patient reported quality of life [Month 3]

    EuroQol-5 Dimension questionnaire: results generated as 5 digit number corresponding to different aspects of quality of life

  9. Patient reported quality of life [Month 6]

    EuroQol-5 Dimension questionnaire: results generated as 5 digit number corresponding to different aspects of quality of life

  10. Correlation between type of surgery and gait variability [10 days before surgery +/- 3 days]

    Classified as either arthrodesis or prosthesis

  11. Correlation between type of surgery and gait variability [Month 3]

    Classified as either arthrodesis or prosthesis

  12. Correlation between type of surgery and gait variability [Month 6]

    Classified as either arthrodesis or prosthesis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Polyclinique Grand Sud Nimes France
2 CHU Nîmes Nîmes France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Alexis Homs, CHU Nimes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT05231265
Other Study ID Numbers:
  • NIMAO/2020-2/AH-2
First Posted:
Feb 9, 2022
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022