Validation of the French Version of the Back Belief Questionnaire (BBQ)

This study has been terminated.
(difficult recruitment curve)
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01389999
First received: July 7, 2011
Last updated: August 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Back Pain Lower Back Chronic
Other: Questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the French Version of the Back Belief Questionnaire

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Change in French BBQ questionnaire score [ Time Frame: after physical theraphy (3 months) ] [ Designated as safety issue: No ]
    The change in the BBQ score subsequent to physical therapy will be evaluated.


Secondary Outcome Measures:
  • Change in FABQ score [ Time Frame: post physical therapy (3 months) ] [ Designated as safety issue: No ]
    The change in the FABQ questionnaire score following physical therapy will be evaluated.

  • Change in TAMPA score [ Time Frame: post physical therapy (3 months) ] [ Designated as safety issue: No ]
    The change in the TAMPA score following physical therapy will be evaluated.

  • Change in Québec questionnaire score [ Time Frame: post physical therapy (3 months) ] [ Designated as safety issue: No ]
    The change in the Québec questionnaire score following physical therapy will be evaluated.

  • Change in DALLAS questionnaire score [ Time Frame: post physical therapy (3 months) ] [ Designated as safety issue: No ]
    The change in the DALLAS questionnaire score following physical therapy will be evaluated.

  • Change in HAD questionnaire score [ Time Frame: post physical therapy (3 months) ] [ Designated as safety issue: No ]
    The change in the HAD questionnaire score following physical therapy will be evaluated.


Enrollment: 131
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic back pain patients
Patients who have had back pain for at least three months.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients consulting for back pain, present for at least three months.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389999

Locations
France
Centre Hospitalier Universitaire de Nîmes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Arnaud Dupeyron, MD, PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01389999     History of Changes
Other Study ID Numbers: LOCAL/2010/AD-02, 2011-A00270-41
Study First Received: July 7, 2011
Last Updated: August 21, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

ClinicalTrials.gov processed this record on October 23, 2014