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

Lumbar Spinal Stenosis Clinical Trial

— CL3S  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03918512
• Other study ID #: APHP180412
• Status: Not yet recruiting
• Start date: March 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: January 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Christelle NGUYEN, MD, PhD
• Phone: (33) 1 58 41 29 45
• Email: christelle.nguyen2[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Other:
• 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).

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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