NCT02426970|Completed
Are Acceptance and Commitment Related to Treatment Response in Chronic Low Back Pain
COP-PAIN
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COP-PAIN
Sponsor study identifier
Secondary identifiers
OTHER · RCB number
observational
100
1 country
2
Study Start
April 3, 2017
Actual (reported)Primary Completion
April 8, 2019
Actual (reported)Study Completion
April 8, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 8, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 20, 2015
Actual (reported)April 27, 2015
Actual (reported)April 3, 2017
Actual (reported)April 8, 2019
Actual (reported)April 8, 2019
Actual (reported)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)
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
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.
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.
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295, France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
Arnaud Dupeyron, MD, PhD
Centre Hospitalier Universitaire de Nīmes
100 participants (actual enrollment reported by the registry).
First Submitted
April 20, 2015
First Posted
April 27, 2015
Study Start
April 3, 2017
Actual (reported)Interest of the Return to Primary Care of the "Low Back Pain Booklet" of Health Insurance in the Recovery of Common Acute Low Back Pain
Contact the study team to confirm eligibility.
Primary Completion
April 8, 2019
Actual (reported)Study Completion
April 8, 2019
Actual (reported)Last Updated
October 24, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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