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

NCT02426970 | Completed

• 2 other identifiers: AOI/2014/AD-012014-A01373-44
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (44)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnaud Dupeyron, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 27, 2015
• Study Start: April 3, 2017
• Primary Completion: April 8, 2019
• Study Completion: April 8, 2019
• Last Updated: October 24, 2019

Record last verified: 2019-10

Locations

FR (2)