Are Acceptance and Commitment Related to Treatment Response in Chronic Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Are Acceptance and Commitment Related to Treatment Response in Chronic Low Back Pain

Conditions
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Low Back Pain

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lumbar spine pain inpatients<br>The study population corresponds to inpatient rehabilitative care for lumbar spine pain in the Departments of Physical Medicine and Functional Rehabilitation at the Nîmes and Montpellier University Hospitals. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of the patient as a responder or a non responder | 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. | 6 months | 
| Acceptation and Action Questionnaire - II (AAQ-II) score |  | Day -7 (inclusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the AAQ-II Score |  | Day 0 | 
| the AAQ-II Score |  | Month 1 | 
| the AAQ-II Score |  | Month 3 | 
| the AAQ-II Score |  | Month 6 | 
| Oswestry Disability Index |  | Day -7 | 
| Oswestry Disability Index |  | Day 0 | 
| Oswestry Disability Index |  | Month 1 | 
| Oswestry Disability Index |  | Month 3 | 
| Oswestry Disability Index |  | Month 6 | 
| Coping Strategies Questionnaire in French (CSQ-F) |  | Day -7 | 
| Coping Strategies Questionnaire in French (CSQ-F) |  | Day 0 | 
| Coping Strategies Questionnaire in French (CSQ-F) |  | Month 1 | 
| Coping Strategies Questionnaire in French (CSQ-F) |  | Month 3 | 
| Coping Strategies Questionnaire in French (CSQ-F) |  | Month 6 | 
| The Back Beliefs Questionnaire |  | Day -7 | 
| The Back Beliefs Questionnaire |  | Day 0 | 
| The Back Beliefs Questionnaire |  | Month 1 | 
| The Back Beliefs Questionnaire |  | Month 3 | 
| The Back Beliefs Questionnaire |  | Month 6 | 
| The Fear-Avoidance Beliefs Questionnaire |  | Day -7 | 
| The Fear-Avoidance Beliefs Questionnaire |  | Day 0 | 
| The Fear-Avoidance Beliefs Questionnaire |  | Month 1 | 
| The Fear-Avoidance Beliefs Questionnaire |  | Month 3 | 
| The Fear-Avoidance Beliefs Questionnaire |  | Month 6 | 
| The Hospital Anxiety and Depression Scale |  | Day -7 | 
| The Hospital Anxiety and Depression Scale |  | Day -0 | 
| The Hospital Anxiety and Depression Scale |  | Month 1 | 
| The Hospital Anxiety and Depression Scale |  | Month 3 | 
| The Hospital Anxiety and Depression Scale |  | Month 6 | 
| The SF-12 questionnaire |  | Day -7 | 
| The SF-12 questionnaire |  | Day 0 | 
| The SF-12 questionnaire |  | Month 1 | 
| The SF-12 questionnaire |  | Month 3 | 
| The SF-12 questionnaire |  | Month 6 | 
| Average pain over the last 8 days measured via visual analog scale. |  | Day -7 | 
| Average pain over the last 8 days measured via visual analog scale. |  | Day 0 | 
| Average pain over the last 8 days measured via visual analog scale. |  | Month 1 | 
| Average pain over the last 8 days measured via visual analog scale. |  | Month 3 | 
| Average pain over the last 8 days measured via visual analog scale. |  | Month 6 | 
| Maximum 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 0 | 
| Maximum pain over the last 8 days measured via visual analog scale. |  | Month 1 | 
| Maximum pain over the last 8 days measured via visual analog scale. |  | Month 3 | 
| Maximum pain over the last 8 days measured via visual analog scale. |  | Month 6 |