NCT03194607

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

June 15, 2017

Last Update Submit

February 4, 2026

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • Compare the free walking speed in patients (6-minute walk test), before and after surgery

    2 weeks and 6 months

Study Arms (2)

Patients

Other: Functional walk testsOther: 3D analysis of locomotion and postureOther: questionnaires

Controls

Other: Functional walk testsOther: 3D analysis of locomotion and postureOther: questionnaires

Interventions

Functional walk testsOTHER
ControlsPatients
3D analysis of locomotion and postureOTHER
ControlsPatients
questionnairesOTHER
ControlsPatients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

low back pain lumbar spinal stenosis spinal surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (2)

  • 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.

    PMID: 35489687RESULT

  • Gueugnon 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.

    PMID: 39427140DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Interventions

PostureSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2017

First Posted

June 21, 2017

Study Start

September 20, 2016

Primary Completion

July 30, 2018

Study Completion

February 15, 2019

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

FR(1)