Lumbar Spinal StenosisSPEEDNCT03194607
Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis
An observational study of Lumbar Spinal Stenosis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Functional walk tests, 3D analysis of locomotion and posture and questionnaires
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2016to 15 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: low back pain lumbar spinal stenosis spinal surgery
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Functional walk tests, 3D analysis of locomotion and posture, questionnaires
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional walk testsOther
3D analysis of locomotion and postureOther
questionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: Functional walk tests; Other: 3D analysis of locomotion and posture; Other: questionnaires | |
| Controls | Not described Receives: Other: Functional walk tests; Other: 3D analysis of locomotion and posture; Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the free walking speed in patients (6-minute walk test), before and after surgery
Measured: 2 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start20 Sep 2016
- Primary completion30 Jul 2018
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194607
- Sponsor's protocol ID
- GRELAT 2016
- Acronym
- SPEED
- Status last verified
- Feb 2026
- First submitted
- 15 Jun 2017
- Last updated
- 6 Feb 2026
- Results posted
- No
Publications
Gouteron A, Laroche D, Beaurain J, Ksiazek E, Fournel I, Bohm A, Ornetti P, Casillas JM, Armand S, Gueugnon M. Effect of decompression surgery for lumbar spinal stenosis on aerobic capacities during a 6-min walk test: A preliminary cohort study. Ann Phys Rehabil Med. 2023 Mar;66(2):101673. doi: 10.1016/j.rehab.2022.101673. Epub 2022 Dec 1. No abstract available.
PubMed 35489687Gueugnon M, Riglet L, Fournel I, Ksiazek E, Beaurain J, Chapon R, Ornetti P, Laroche D. Evaluation of the sagittal vertical axis with postural and 3D motion analyses in lumbar spinal stenosis. BMC Musculoskelet Disord. 2024 Oct 19;25(1):827. doi: 10.1186/s12891-024-07923-y.
PubMed 39427140
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT03194607
- Acronym / sponsor ID
- SPEED / GRELAT 2016
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Functional walk tests, Other: 3D analysis of locomotion and posture, Other: questionnaires |
| Controls | – | Other: Functional walk tests, Other: 3D analysis of locomotion and posture, Other: questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- low back pain lumbar spinal stenosis spinal surgery
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional walk tests | Other | Controls, Patients |
| 3D analysis of locomotion and posture | Other | Controls, Patients |
| questionnaires | Other | Controls, Patients |
Primary outcome
Compare the free walking speed in patients (6-minute walk test), before and after surgery
Time frame: 2 weeks and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 35489687Gouteron A, Laroche D, Beaurain J, Ksiazek E, Fournel I, Bohm A, Ornetti P, Casillas JM, Armand S, Gueugnon M. Effect of decompression surgery for lumbar spinal stenosis on aerobic capacities during a 6-min walk test: A preliminary cohort study. Ann Phys Rehabil Med. 2023 Mar;66(2):101673. doi: 10.1016/j.rehab.2022.101673. Epub 2022 Dec 1. No abstract available.
- Derived from this study: PubMed 39427140Gueugnon M, Riglet L, Fournel I, Ksiazek E, Beaurain J, Chapon R, Ornetti P, Laroche D. Evaluation of the sagittal vertical axis with postural and 3D motion analyses in lumbar spinal stenosis. BMC Musculoskelet Disord. 2024 Oct 19;25(1):827. doi: 10.1186/s12891-024-07923-y.
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LUMBAR STENOSIS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the free walking speed in patients (6-minute walk test), before and after surgery (time frame: 2 weeks and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194607, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.