NCT05231265 Effect of Lumbar Surgery on Complexity During a Walking Task in Chronic Low Back Pain
| NCT ID | NCT05231265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Low Back Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 32 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 32 participants in total. It began in 2023-10-16 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Alexis Homs
PRINCIPAL INVESTIGATOR
CHU Nimes
Frequently Asked Questions
Who can join the NCT05231265 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05231265 currently recruiting?
Yes, NCT05231265 is actively recruiting participants. Contact the research team at alexis.homs@chu-nimes.fr for enrollment information.
Where is the NCT05231265 trial being conducted?
This trial is being conducted at Nîmes, France, Nîmes, France.
Who is sponsoring the NCT05231265 clinical trial?
NCT05231265 is sponsored by Centre Hospitalier Universitaire de Nīmes. The principal investigator is Alexis Homs at CHU Nimes. The trial plans to enroll 32 participants.