Development and Validation of a Questionnaire for Assessing Activity Limitation in Patients With Lumbar Spinal Stenosis : The Cochin L3S Questionnaire.

Development and Validation of a Questionnaire for Assessing Activity Limitation in Patients With Lumbar Spinal Stenosis : The Cochin L3S Questionnaire

Sponsors

Lead sponsor: Assistance Publique - Hôpitaux de Paris

Source Assistance Publique - Hôpitaux de 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

Overall Status Not yet recruiting
Start Date March 1, 2020
Completion Date March 1, 2021
Primary Completion Date December 1, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Lumbar Spinal Stenosis-specific activity limitation in patients with Lumbar Spinal Stenosis at baseline
Enrollment 200
Condition
Intervention

Intervention type: Other

Intervention name: nine online self-administered questionnaires

Description: 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

Sampling method: Non-Probability Sample

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.

Gender: All

Minimum age: 50 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Christelle NGUYEN, MD, PhD Principal Investigator APHP (assistance publique hôpitaux de Paris)
Overall Contact

Last name: Christelle NGUYEN, MD, PhD

Phone: (33) 1 58 41 29 45

Email: [email protected]

Location
facility contact
Hôpital Cochin Christelle NGUYEN, MD, PhD (33) 1 58 41 29 45 [email protected]
Location Countries

France

Verification Date

January 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym CL3S
Patient Data No
Study Design Info

Observational model: Case-Control

Time perspective: Prospective

Source: ClinicalTrials.gov