SPEED: Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Unknown status
CT.gov ID
NCT03194607
Collaborator
(none)
60
1
38.3
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Functional walk tests
  • Other: 3D analysis of locomotion and posture
  • Other: questionnaires

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis
Actual Study Start Date :
Sep 20, 2016
Anticipated Primary Completion Date :
May 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Compare the free walking speed in patients (6-minute walk test), before and after surgery [2 weeks and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Dijon Bourgogne Dijon France 21000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT03194607
Other Study ID Numbers:
  • GRELAT 2016
First Posted:
Jun 21, 2017
Last Update Posted:
Jul 31, 2018
Last Verified:
Jul 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 31, 2018