Development and Validation of a Questionnaire for Assessing Activity Limitation in Patients With Lumbar Spinal Stenosis : The Cochin L3S Questionnaire (CL3S)

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

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

Study Overview

• Status: Unknown
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Other: nine online self-administered questionnaires

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

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Christelle NGUYEN, MD, PhD; Phone Number: (33) 1 58 41 29 45; Email: christelle.nguyen2@aphp.fr
• Study Contact Backup: Name: Caroline TOURTE; Phone Number: (33) 1 58 41 11 90; Email: caroline.tourte@aphp.fr

Study Locations

• France
  • Paris, France, 75014
    • Hopital Cochin
    • Contact: Christelle NGUYEN, MD, PhD; Phone Number: (33) 1 58 41 29 45; Email: christelle.nguyen2@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Christelle NGUYEN, MD, PhD, APHP (assistance publique hôpitaux de Paris)

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Lumbar spinal stenosis; LSS specific activity limitation; development and validation of new questionaire
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: APHP180412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No