FibromyalgiaNCT02270775
Traduction and Validation of the Central Sentitization Inventory Into French
An observational study of Fibromyalgia and Heathy Volunteers, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The study will include a translation of the Central Sensisization Inventory into French and a cultural validation of the French version of the questionnaire (Reliability, discrimination and comparison with other questionnaires). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Heathy Volunteers
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Jun 2015
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 3 groups: Fibromyalgia Patients (group 1) Acute or subacute Ankle Sprain (Group 2) Healthy Volunteers (Group 3)
Who may be able to join
- Clinical Diagnosis of Fibromyalgia (Group 1)
- Clinical Diagnosis of a Acute of Subacute Ankle Spain (Group 2)
- Healthy Volunteer (Group 3)
Who cannot join
- Having any chronic pain (group 1 and group 2)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200
About this study
The study will include a translation of the Central Sensisization Inventory into French and a cultural validation of the French version of the questionnaire (Reliability, discrimination and comparison with other questionnaires).
- Conditions
- Fibromyalgia, Heathy Volunteers
- Keywords
- Questionnaire, Translation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia Patients | The central Sensitization questionnaire will be filled in by each patients included. After One week, patients will filled it the questionnaire again to study the reliability. | |
| Ankle sprain Patients | The central Sensitization questionnaire will be filled in by each patients included. | |
| Healthy Volunteers | The central Sensitization questionnaire will be filled in by each volunteer included. After One week, volunteers will filled it the questionnaire again to study the reliability. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the French version the Central Sensitization Inventory Score
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270775
- Sponsor's protocol ID
- CSI-French
- Status last verified
- Oct 2014
- First submitted
- 17 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traduction and Validation of the Central Sentitization Inventory Into French
- ClinicalTrials.gov ID
- NCT02270775
- Acronym / sponsor ID
- CSI-French
- Conditions
- Fibromyalgia, Heathy Volunteers
- Keywords
- Questionnaire, Translation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (estimated)
- First posted
- 21 Oct 2014 (estimated)
- 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.
The study will include a translation of the Central Sensisization Inventory into French and a cultural validation of the French version of the questionnaire (Reliability, discrimination and comparison with other questionnaires).
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia Patients | – | –The central Sensitization questionnaire will be filled in by each patients included. After One week, patients will filled it the questionnaire again to study the reliability. |
| Ankle sprain Patients | – | –The central Sensitization questionnaire will be filled in by each patients included. |
| Healthy Volunteers | – | –The central Sensitization questionnaire will be filled in by each volunteer included. After One week, volunteers will filled it the questionnaire again to study the reliability. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 3 groups: Fibromyalgia Patients (group 1) Acute or subacute Ankle Sprain (Group 2) Healthy Volunteers (Group 3)
Key inclusion criteria (3 listed)
- Clinical Diagnosis of Fibromyalgia (Group 1)
- Clinical Diagnosis of a Acute of Subacute Ankle Spain (Group 2)
- Healthy Volunteer (Group 3)
Key exclusion criteria (1 listed)
- Having any chronic pain (group 1 and group 2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability of the French version the Central Sensitization Inventory Score
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fibromyalgia and Heathy Volunteers, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Oct 2014. 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 Belgium. 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?
Results are not available in the source record.
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?
Reliability of the French version the Central Sensitization Inventory Score (time frame: 1 week). 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 21 Oct 2014.