NCT03918512

Brief Summary

To develop and validate a questionnaire aiming at assessing specific activity limitation in patients with lumbar spinal stenosis (LSS).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 15, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 15, 2019

Last Update Submit

March 10, 2026

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar spinal stenosisLSS specific activity limitationdevelopment and validation of new questionaire

Outcome Measures

Primary Outcomes (1)

  • Lumbar Spinal Stenosis-specific activity limitation in patients with Lumbar Spinal Stenosis

    To develop and validate a questionnaire aiming at assessing specific activity limitation in patients with LSS

    at baseline

Interventions

nine online self-administered questionnairesOTHER

patients will be invited to complete the following nine online self-administered questionnaires at baseline, 7 days and 3 months: * Demographical and clinical characteristics at baseline * Consolidated version of the CSS-48 questionnaire * Lumbar pain numeric rating scale (NRS) * Radicular pain NRS * Zurich Claudication Questionnaire (ZCQ) (physical function subscale) * Oswestry Disability Index (ODI) * Fukushima LSS Scale 25 (FLS-25) * 12-Item Short Form Health Survey (SF-12) * Anchoring questions : 1 anchoring question about patient acceptable symptom state (at baseline, 7 days and 3 month) and 1 anchoring question about patient minimal clinically important difference (at 3 months).

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Rheumatology Department of Limoges Hospital and the Rehabilitation Department of Cochin Hospital, Paris

You may qualify if:

  • patients ≥ 50 year old
  • with lumbar spinal stenosis (LSS) according to medical records.

You may not qualify if:

  • lumbar spinal surgery,
  • cognitive impairment and inability to speak and/or understand French.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin

Paris, France, 75014, France

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Christelle NGUYEN, MD, PhD

    APHP (assistance publique hôpitaux de Paris)

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

March 15, 2019

First Posted

April 17, 2019

Study Start

March 1, 2020

Primary Completion

December 1, 2020

Study Completion

March 1, 2021

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)