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NCT Number: NCT05231265

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nîmes, Nîmes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking task

Other

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

Primary outcomes

  1. Gait complexity

    Time frame: 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

    Time frame: Month 3

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

  3. Gait complexity

    Time frame: Month 6

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

Secondary outcomes

  1. Patient reported pain

    Time frame: 10 days before surgery +/- 3 days

    Visual analog scale (0-100)

  2. Patient reported pain

    Time frame: Month 3

    Visual analog scale (0-100)

  3. Patient reported pain

    Time frame: Month 6

    Visual analog scale (0-100)

  4. Apprehension of pain of movement

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 10 days before surgery +/- 3 days

    Classified as either arthrodesis or prosthesis

  11. Correlation between type of surgery and gait variability

    Time frame: Month 3

    Classified as either arthrodesis or prosthesis

  12. Correlation between type of surgery and gait variability

    Time frame: Month 6

    Classified as either arthrodesis or prosthesis

Study contacts

Contact information is provided by the study sponsor or research team.

Alexis Homs

CONTACT

[email protected]

04.66.68.34.59

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: LOBAFRACS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2022
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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