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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01389999
Other study ID # LOCAL/2010/AD-02
Secondary ID 2011-A00270-41
Status Terminated
Phase N/A
First received July 7, 2011
Last updated March 24, 2015
Start date January 2012
Est. completion date October 2014

Study information

Verified date March 2015
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
Study type Observational

Clinical Trial Summary

The goal of this study is to carry out a transcultural validation of the Back Belief Questionnaire in order to assess its appropriateness for French-speaking populations.


Recruitment information / eligibility

Status Terminated
Enrollment 131
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- The patient must have given his/her informed and signed consent

- The patient must be insured or beneficiary of a health insurance plan

- The patient has had back pain for at least 3 months

Exclusion Criteria:

- The patient is in an exclusion period determined by a previous study

- The patient is under judicial protection, under tutorship or curatorship

- The patient refuses to sign the consent

- It is impossible to correctly inform the patient

- The patient is pregnant

- The patient is breastfeeding

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Questionnaires
Each patient is asked to fill out several questionnaires: a french version of the BBQ, as well as the FABQ, the TAMPA score, and the Québec questionnaire, the Dallas score, the HAD score and a visual analog scale for pain.

Locations

Country Name City State
France Centre Hospitalier Universitaire de Nîmes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in French BBQ questionnaire score The change in the BBQ score subsequent to physical therapy will be evaluated. after physical theraphy (3 months) No
Secondary Change in FABQ score The change in the FABQ questionnaire score following physical therapy will be evaluated. post physical therapy (3 months) No
Secondary Change in TAMPA score The change in the TAMPA score following physical therapy will be evaluated. post physical therapy (3 months) No
Secondary Change in Québec questionnaire score The change in the Québec questionnaire score following physical therapy will be evaluated. post physical therapy (3 months) No
Secondary Change in DALLAS questionnaire score The change in the DALLAS questionnaire score following physical therapy will be evaluated. post physical therapy (3 months) No
Secondary Change in HAD questionnaire score The change in the HAD questionnaire score following physical therapy will be evaluated. post physical therapy (3 months) No
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