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

ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Walking task

    Other intervention

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

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Patients with Low Back Pain1 intervention

Trial outcomes

Primary outcomes

1

Gait complexity

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

Time frame
10 days before surgery +/- 3 days
2

Gait complexity

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

Time frame
Month 3
3

Gait complexity

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

Time frame
Month 6

Secondary outcomes

1

Patient reported pain

Visual analog scale (0-100)

Time frame
10 days before surgery +/- 3 days
2

Patient reported pain

Visual analog scale (0-100)

Time frame
Month 3
3

Patient reported pain

Visual analog scale (0-100)

Time frame
Month 6
4

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)

Time frame
10 days before surgery +/- 3 days

Other outcomes

Sponsors and contacts

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