Development and Validation of a Questionnaire for Assessing Activity Limitation in Patients With Lumbar Spinal Stenosis : The Cochin L3S Questionnaire
NCT ID: NCT03918512
Last Updated: 2020-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2020-03-01
2021-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Muscle Function and Pelvic Stability While Walking in Patients With Symptomatic Lumbar Spinal Stenosis
NCT03951935
Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis
NCT03194607
Effects of Remote Ischemic Conditioning on Hand Use in Individuals With SCI and ALS
NCT03851302
Sit-to-stand With Feedback in SCI Patients
NCT02913911
Effect of Number of Remote Limb Ischemic Conditioning Cycles on Learning Enhancement
NCT03512041
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In a first step, semi-structured in-depth individual interviews were conducted from September 20, 2016 to January 4, 2017, in 20 patients fulfilling inclusion criteria to collect concepts related to LSS-specific activity limitation, participation restriction and patients' views about their condition. Thematic content was analysed using investigator triangulation. Overall, 57 items were generated by patients. 48 items were related to LSS-specific activity limitation and were used to construct the provisional 48-item Cochin L3S questionnaire (CL3S-48). Acceptability and understandability of the provisional CL3S-48 questionnaire was tested and consolidated in 10 patients with LSS.
Item reduction and validation of the questionnaire :
In a second step, 200 eligible patients according to our medical records will be informed by email of the purpose of the study, their non-opposition to the collection of data will be collected and patients will be invited to complete the following online self-administered questionnaires at baseline, 7 days and 3 months:
* Demographical and clinical characteristics at baseline
* Consolidated version of the CL3S-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)
* 1 anchoring question about patient acceptable symptom state
* 1 anchoring question about patient minimal clinically important difference at 3 months.
In a third step, the number of items will be reduced according to their metrological qualities. The psychometric properties of the new scale will be assessed and the scale will be consolidated to provide the final questionnaire
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
nine online self-administered questionnaires
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* with lumbar spinal stenosis (LSS) according to medical records.
Exclusion Criteria
* cognitive impairment and inability to speak and/or understand French.
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christelle NGUYEN, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
APHP (assistance publique hôpitaux de Paris)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Cochin
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APHP180412
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.