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

Lumbar Spinal Stenosis Clinical Trial

— SPEED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194607
• Other study ID #: GRELAT 2016
• Status: Completed
• Start date: September 20, 2016
• Est. completion date: February 15, 2019

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 15, 2019
• Est. primary completion date: July 30, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Other:
• Functional walk tests

• 3D analysis of locomotion and posture

• questionnaires

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the free walking speed in patients (6-minute walk test), before and after surgery		2 weeks and 6 months