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

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ClinicalTrials.gov Identifier: NCT03194607
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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
Lumbar Spinal Stenosis Other: Functional walk tests Other: 3D analysis of locomotion and posture Other: questionnaires

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Study Type : Observational
Estimated 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 : September 20, 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Group/Cohort 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



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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
low back pain lumbar spinal stenosis spinal surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194607


Contacts
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Contact: Michaël GRELAT +33 3.80.29.52.00 mickael.grelat@chu-dijon.fr

Locations
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France
Chu Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: Michaël GRELAT    +33 3.80.29.52.00    mickael.grelat@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03194607     History of Changes
Other Study ID Numbers: GRELAT 2016
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases