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

Completed

• Conditions: Low Back Pain

• Registration Number: NCT02426970
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-27
• Study Start: 2017-04-03
• Primary Completion: 2019-04-08
• Study Completion: 2019-04-08
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The Hospital Anxiety and Depression Scale	Month 6
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.	Month 6
The SF-12 questionnaire	Month 6
Oswestry Disability Index	Month 6
The Fear-Avoidance Beliefs Questionnaire	Month 6
the AAQ-II Score	Month 6
Coping Strategies Questionnaire in French (CSQ-F)	Month 6
The Back Beliefs Questionnaire	Month 6

Trial Locations

Locations (2)

CHRU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France