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

Centre Hospitalier Universitaire de Nīmes100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Low Back Pain

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (2)

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Acceptation and Action Questionnaire - II (AAQ-II) score

Time frame: Day -7 (inclusion)

Secondary Outcomes

the AAQ-II Score

Time frame: Day 0

the AAQ-II Score

Time frame: Month 1

the AAQ-II Score

Time frame: Month 3

the AAQ-II Score

Time frame: Month 6

Oswestry Disability Index

Time frame: Day -7

Oswestry Disability Index

Time frame: Day 0

Oswestry Disability Index

Time frame: Month 1

Oswestry Disability Index

Time frame: Month 3

Oswestry Disability Index

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.