Low Back Pain
Conditions
Brief summary
The main objective of this study is to evaluate whether acceptance (measured by the AAQ-II questionnaire) is prognostic of algo-functional changes measured by the Oswestry Disability Index, ODI) at 6 months.
Detailed description
The secondary objectives are: A. To search for correlations between the acceptance score (AAQ-II Questionnaire) and scores for coping (CSQ), avoidance (FABQ), understanding (BBQ), anxiety and depression (HADS) and quality of life (SF-12) at baseline. B. To describe the kinetics of changes in various parameters (acceptance, coping, avoidance, understanding, anxiety and depression, quality of life, ODI) over 6 months. C. To evaluate the agreement between two methods of questionnaire presentation: Paper collection versus collection by Tablet PC.
Interventions
None listed
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* The patient has been informed about the study, and is not opposed to the study * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 6 month of follow-up * The subject has chronic back pain that is not post-operative in nature and that has lasted for more than 3 months * The subject accepts the re-education curriculum.
Exclusion criteria
* The patient is participating in another study * 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 participate * It is impossible to correctly inform the patient * The patient is pregnant, parturient, or breastfeeding * The subject has a history of chronic obstructive pulmonary disease, cardiovascular disease, rheumatoid arthritis, lupus, spondylitis or neoplastic disease. * Patient currently under psychological treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Classification of the patient as a responder or a non responder | 6 months | The response to treatment will be evaluated by the ODI (Oswestry Disability Index) at 6 months: a patient will be considered as a responder when the absolute change between the score at 6 months and inclusion is at least 10 points (Ostelo RW et al., 2008). This outcome is a qualitative variable with two options: responder or non-responder. The fact that we define in an apriori fashion who is a responder or not does not mean that we have created multiple outcomes. This is a single outcome. |
| Acceptation and Action Questionnaire - II (AAQ-II) score | Day -7 (inclusion) | — |
Secondary
| Measure | Time frame |
|---|---|
| Coping Strategies Questionnaire in French (CSQ-F) | Day -7 |
| The Back Beliefs Questionnaire | Day -7 |
| The Fear-Avoidance Beliefs Questionnaire | Day -7 |
| the AAQ-II Score | Day 0 |
| The SF-12 questionnaire | Day -7 |
| Average pain over the last 8 days measured via visual analog scale. | Day -7 |
| Maximum pain over the last 8 days measured via visual analog scale. | Day -7 |
| The Hospital Anxiety and Depression Scale | Day -7 |
| Oswestry Disability Index | Day -7 |
Countries
France
Outcome results
None listed