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

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ClinicalTrials.gov Identifier: NCT03918512
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment
Lumbar Spinal Stenosis 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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Development and Validation of a Questionnaire for Assessing Activity Limitation in Patients With Lumbar Spinal Stenosis : The Cochin L3S Questionnaire.
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Groups and Cohorts
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Intervention Details:
  • 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).

Outcome Measures
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Primary Outcome Measures :
  1. Lumbar Spinal Stenosis-specific activity limitation in patients with Lumbar Spinal Stenosis [ Time Frame: at baseline ]
    To develop and validate a questionnaire aiming at assessing specific activity limitation in patients with LSS


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rheumatology Department of Limoges Hospital and the Rehabilitation Department of Cochin Hospital, Paris
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918512


Contacts
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Contact: Christelle NGUYEN, MD, PhD (33) 1 58 41 29 45 christelle.nguyen2@aphp.fr
Contact: Caroline TOURTE (33) 1 58 41 11 90 caroline.tourte@aphp.fr

Locations
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France
Hôpital Cochin Not yet recruiting
Paris, France, 75014
Contact: Christelle NGUYEN, MD, PhD    (33) 1 58 41 29 45    christelle.nguyen2@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Christelle NGUYEN, MD, PhD APHP (assistance publique hôpitaux de Paris)
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03918512     History of Changes
Other Study ID Numbers: APHP180412
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Lumbar spinal stenosis
LSS specific activity limitation
development and validation of new questionaire
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases