Development & Validation of a Questionnaire for Assessing Activity

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03918512
Study type	Observational
Source	Assistance Publique - Hôpitaux de Paris
Contact	Christelle NGUYEN, MD, PhD
Phone	(33) 1 58 41 29 45
Email	christelle.nguyen2@aphp.fr
Status	Not yet recruiting
Phase
Start date	March 1, 2020
Completion date	March 1, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms