Clinical trial NCT03918512: Development and Validation of a Questionnaire for Assessing Activity Limitation in Patients With Lumbar Spinal Stenosis : The Cochin L3S Questionnaire
Official title: Development and Validation of a Questionnaire for Assessing Activity Limitation in Patients With Lumbar Spinal Stenosis : The Cochin L3S Questionnaire.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Spinal Stenosis
Keywords: Lumbar spinal stenosis
LSS specific activity limitation
development and validation of new questionaire
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatology Department of Limoges Hospital and the Rehabilitation Department of Cochin Hospital, Paris

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

Detailed description: Construction of the provisional questionnaire :

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Lumbar Spinal Stenosis-specific activity limitation in patients with Lumbar Spinal Stenosis
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: APHP (assistance publique hôpitaux de Paris)
name: Christelle NGUYEN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: