NCT02270775

Brief 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

October 17, 2014

Last Update Submit

October 17, 2014

Conditions

Keywords

QuestionnaireTranslation

Outcome Measures

Primary Outcomes (1)

  • Reliability of the French version the Central Sensitization Inventory Score

    1 week

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

3 groups: Fibromyalgia Patients (group 1) Acute or subacute Ankle Sprain (Group 2) Healthy Volunteers (Group 3)

You may qualify if:

  • Clinical Diagnosis of Fibromyalgia (Group 1)
  • Clinical Diagnosis of a Acute of Subacute Ankle Spain (Group 2)
  • Healthy Volunteer (Group 3)

You may not qualify if:

  • Having any chronic pain (group 1 and group 2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2014

First Posted

October 21, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Last Updated

October 21, 2014

Record last verified: 2014-10

Locations