Clinical trial NCT02426970: Are Acceptance and Commitment Related to Treatment Response in Chronic Low Back Pain
Official title: Are Acceptance and Commitment Related to Treatment Response in Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Classification of the patient as a responder or a non responder
timeFrame: 6 months
measure: Acceptation and Action Questionnaire - II (AAQ-II) score
timeFrame: Day -7 (inclusion)
Secondary outcomes:
measure: the AAQ-II Score
timeFrame: Day 0
measure: the AAQ-II Score
timeFrame: Month 1
measure: the AAQ-II Score
timeFrame: Month 3
measure: the AAQ-II Score
timeFrame: Month 6
measure: Oswestry Disability Index
timeFrame: Day -7
measure: Oswestry Disability Index
timeFrame: Day 0
measure: Oswestry Disability Index
timeFrame: Month 1
measure: Oswestry Disability Index
timeFrame: Month 3
measure: Oswestry Disability Index
timeFrame: Month 6
measure: Coping Strategies Questionnaire in French (CSQ-F)
timeFrame: Day -7
measure: Coping Strategies Questionnaire in French (CSQ-F)
timeFrame: Day 0
measure: Coping Strategies Questionnaire in French (CSQ-F)
timeFrame: Month 1
measure: Coping Strategies Questionnaire in French (CSQ-F)
timeFrame: Month 3
measure: Coping Strategies Questionnaire in French (CSQ-F)
timeFrame: Month 6
measure: The Back Beliefs Questionnaire
timeFrame: Day -7
measure: The Back Beliefs Questionnaire
timeFrame: Day 0
measure: The Back Beliefs Questionnaire
timeFrame: Month 1
measure: The Back Beliefs Questionnaire
timeFrame: Month 3
measure: The Back Beliefs Questionnaire
timeFrame: Month 6
measure: The Fear-Avoidance Beliefs Questionnaire
timeFrame: Day -7
measure: The Fear-Avoidance Beliefs Questionnaire
timeFrame: Day 0
measure: The Fear-Avoidance Beliefs Questionnaire
timeFrame: Month 1
measure: The Fear-Avoidance Beliefs Questionnaire
timeFrame: Month 3
measure: The Fear-Avoidance Beliefs Questionnaire
timeFrame: Month 6
measure: The Hospital Anxiety and Depression Scale
timeFrame: Day -7
measure: The Hospital Anxiety and Depression Scale
timeFrame: Day -0
measure: The Hospital Anxiety and Depression Scale
timeFrame: Month 1
measure: The Hospital Anxiety and Depression Scale
timeFrame: Month 3
measure: The Hospital Anxiety and Depression Scale
timeFrame: Month 6
measure: The SF-12 questionnaire
timeFrame: Day -7
measure: The SF-12 questionnaire
timeFrame: Day 0
measure: The SF-12 questionnaire
timeFrame: Month 1
measure: The SF-12 questionnaire
timeFrame: Month 3
measure: The SF-12 questionnaire
timeFrame: Month 6
measure: Average pain over the last 8 days measured via visual analog scale.
timeFrame: Day -7
measure: Average pain over the last 8 days measured via visual analog scale.
timeFrame: Day 0
measure: Average pain over the last 8 days measured via visual analog scale.
timeFrame: Month 1
measure: Average pain over the last 8 days measured via visual analog scale.
timeFrame: Month 3
measure: Average pain over the last 8 days measured via visual analog scale.
timeFrame: Month 6
measure: Maximum pain over the last 8 days measured via visual analog scale.
timeFrame: Day -7
measure: Maximum pain over the last 8 days measured via visual analog scale.
timeFrame: Day 0
measure: Maximum pain over the last 8 days measured via visual analog scale.
timeFrame: Month 1
measure: Maximum pain over the last 8 days measured via visual analog scale.
timeFrame: Month 3
measure: Maximum pain over the last 8 days measured via visual analog scale.
timeFrame: Month 6
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Lapeyronie
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Arnaud Dupeyron, MD, PhD
role: STUDY_DIRECTOR
References: