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

NCT ID: NCT02426970

Last Updated: 2019-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-03

Study Completion Date

2019-04-08

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lumbar spine pain inpatients

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud Dupeyron, MD, PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

Site Status

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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2014-A01373-44

Identifier Type: OTHER

Identifier Source: secondary_id

AOI/2014/AD-01

Identifier Type: -

Identifier Source: org_study_id

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