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

Low Back Pain Clinical Trial

— COP-PAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426970
• Other study ID #: AOI/2014/AD-01
• Secondary ID: 2014-A01373-44
• Status: Completed
• Start date: April 3, 2017
• Est. completion date: April 8, 2019

Study information

• Verified date: October 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Locations

Country	Name	City	State
France	CHRU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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