Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal… (NCT03194607) | Clinical Trial Compass
CompletedNot Applicable
Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis
France40 participantsStarted 2016-09-20
Plain-language summary
Low back pain is a leading cause of medical consultations in France and in other industrialized countries. Although spinal surgery is a recognized treatment, to date, its impact has only been assessed using subjective or declarative criteria. Yet, in many orthopaedic diseases, it has been shown that the evaluation of functional capacities, including walking speed, is particularly useful to study the impact of these diseases and their treatment. To date, no study has attempted to assess the impact of spinal surgery by evaluating 1) the functional capacities of patients and 2) spatio-temporal parameters of locomotion and joint dynamics. The investigators hypothesize that spinal surgery in patients with symptomatic lumbar spinal stenosis should lead to an improvement in quantifiable locomotion parameters, and in particular walking speed. Walking speed is a quantitative measurement, which could reflect the degree of functional impairment of the patient before and after surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patient:
* more than 18 years old
* who has provided verbal consent
* with acquired arthritic lumbar spinal stenosis
* eligible for surgery (pain \> 3 months, resistant to medical treatment)
* for whom the neurosurgeon has scheduled nerve decompression without osteosynthesis or instrumentation
* able to walk ≥ 10 metres without help
Exclusion Criteria:
Patient:
* Adult under guardianship
* Absence of health insurance cover
* Pregnant or breast-feeding women
* History of lumbar spinal surgery involving posterior or anterior arthrodesis
* History of lumbar spinal surgery involving arthroplasty
* History of lumbar spinal surgery within the previous 12 months
* Locomotor disorders due to causes other than spine disease (orthopaedic, neurological, vascular, cardiac…) that could significantly affect walking speed
* patients in whom the surgery could not be done or deferred (intolerance to the ventral decubitus position, infection…)
* patients who had revisit surgery before M6 (with the exception of early revisit surgery during the first month post-intervention)
* patients in whom osteosynthesis or the implantation of instruments was decided and done during the surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare the free walking speed in patients (6-minute walk test), before and after surgery