Lumbar Spinal StenosisCL3SNCT03918512
Development and Validation of a Questionnaire for Assessing Activity Limitation in Patients With Lumbar Spinal Stenosis : The Cochin L3S Questionnaire
An observational study of Lumbar Spinal Stenosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To develop and validate a questionnaire aiming at assessing specific activity limitation in patients with lumbar spinal stenosis (LSS). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- nine online self-administered questionnaires
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatology Department of Limoges Hospital and the Rehabilitation Department of Cochin Hospital, Paris
Who may be able to join
- patients ≥ 50 year old
- with lumbar spinal stenosis (LSS) according to medical records.
Who cannot join
- lumbar spinal surgery,
- cognitive impairment and inability to speak and/or understand French.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- nine online self-administered questionnaires
- Keywords
- Lumbar spinal stenosis, LSS specific activity limitation, development and validation of new questionaire
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nine online self-administered questionnairesOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start1 Mar 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Why it stopped: Abandonment of the study project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christelle NGUYEN, MD, PhD, Principal investigator, APHP (assistance publique hôpitaux de Paris)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918512
- Sponsor's protocol ID
- APHP180412
- Acronym
- CL3S
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2019
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Questionnaire for Assessing Activity Limitation in Patients With Lumbar Spinal Stenosis : The Cochin L3S Questionnaire.
- ClinicalTrials.gov ID
- NCT03918512
- Acronym / sponsor ID
- CL3S / APHP180412
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Lumbar spinal stenosis, LSS specific activity limitation, development and validation of new questionaire
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Abandonment of the study project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatology Department of Limoges Hospital and the Rehabilitation Department of Cochin Hospital, Paris
Key inclusion criteria (2 listed)
- patients ≥ 50 year old
- with lumbar spinal stenosis (LSS) according to medical records.
Key exclusion criteria (2 listed)
- lumbar spinal surgery,
- cognitive impairment and inability to speak and/or understand French.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nine online self-administered questionnairespatients 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). | Other | – |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle NGUYEN, MD, PhD principal investigator
APHP (assistance publique hôpitaux de Paris)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar Spinal Stenosis-specific activity limitation in patients with Lumbar Spinal Stenosis (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.