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Are Acceptance and Commitment Related to Treatment Response in Chronic Low Back Pain (COP-PAIN)

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ClinicalTrials.gov Identifier: NCT02426970
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Low Back Pain

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Are Acceptance and Commitment Related to Treatment Response in Chronic Low Back Pain
Actual Study Start Date : April 3, 2017
Actual Primary Completion Date : April 8, 2019
Actual Study Completion Date : April 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort
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.



Primary Outcome Measures :
  1. Classification of the patient as a responder or a non responder [ Time Frame: 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.


  2. Acceptation and Action Questionnaire - II (AAQ-II) score [ Time Frame: Day -7 (inclusion) ]

Secondary Outcome Measures :
  1. the AAQ-II Score [ Time Frame: Day 0 ]
  2. the AAQ-II Score [ Time Frame: Month 1 ]
  3. the AAQ-II Score [ Time Frame: Month 3 ]
  4. the AAQ-II Score [ Time Frame: Month 6 ]
  5. Oswestry Disability Index [ Time Frame: Day -7 ]
  6. Oswestry Disability Index [ Time Frame: Day 0 ]
  7. Oswestry Disability Index [ Time Frame: Month 1 ]
  8. Oswestry Disability Index [ Time Frame: Month 3 ]
  9. Oswestry Disability Index [ Time Frame: Month 6 ]
  10. Coping Strategies Questionnaire in French (CSQ-F) [ Time Frame: Day -7 ]
  11. Coping Strategies Questionnaire in French (CSQ-F) [ Time Frame: Day 0 ]
  12. Coping Strategies Questionnaire in French (CSQ-F) [ Time Frame: Month 1 ]
  13. Coping Strategies Questionnaire in French (CSQ-F) [ Time Frame: Month 3 ]
  14. Coping Strategies Questionnaire in French (CSQ-F) [ Time Frame: Month 6 ]
  15. The Back Beliefs Questionnaire [ Time Frame: Day -7 ]
  16. The Back Beliefs Questionnaire [ Time Frame: Day 0 ]
  17. The Back Beliefs Questionnaire [ Time Frame: Month 1 ]
  18. The Back Beliefs Questionnaire [ Time Frame: Month 3 ]
  19. The Back Beliefs Questionnaire [ Time Frame: Month 6 ]
  20. The Fear-Avoidance Beliefs Questionnaire [ Time Frame: Day -7 ]
  21. The Fear-Avoidance Beliefs Questionnaire [ Time Frame: Day 0 ]
  22. The Fear-Avoidance Beliefs Questionnaire [ Time Frame: Month 1 ]
  23. The Fear-Avoidance Beliefs Questionnaire [ Time Frame: Month 3 ]
  24. The Fear-Avoidance Beliefs Questionnaire [ Time Frame: Month 6 ]
  25. The Hospital Anxiety and Depression Scale [ Time Frame: Day -7 ]
  26. The Hospital Anxiety and Depression Scale [ Time Frame: Day -0 ]
  27. The Hospital Anxiety and Depression Scale [ Time Frame: Month 1 ]
  28. The Hospital Anxiety and Depression Scale [ Time Frame: Month 3 ]
  29. The Hospital Anxiety and Depression Scale [ Time Frame: Month 6 ]
  30. The SF-12 questionnaire [ Time Frame: Day -7 ]
  31. The SF-12 questionnaire [ Time Frame: Day 0 ]
  32. The SF-12 questionnaire [ Time Frame: Month 1 ]
  33. The SF-12 questionnaire [ Time Frame: Month 3 ]
  34. The SF-12 questionnaire [ Time Frame: Month 6 ]
  35. Average pain over the last 8 days measured via visual analog scale. [ Time Frame: Day -7 ]
  36. Average pain over the last 8 days measured via visual analog scale. [ Time Frame: Day 0 ]
  37. Average pain over the last 8 days measured via visual analog scale. [ Time Frame: Month 1 ]
  38. Average pain over the last 8 days measured via visual analog scale. [ Time Frame: Month 3 ]
  39. Average pain over the last 8 days measured via visual analog scale. [ Time Frame: Month 6 ]
  40. Maximum pain over the last 8 days measured via visual analog scale. [ Time Frame: Day -7 ]
  41. Maximum pain over the last 8 days measured via visual analog scale. [ Time Frame: Day 0 ]
  42. Maximum pain over the last 8 days measured via visual analog scale. [ Time Frame: Month 1 ]
  43. Maximum pain over the last 8 days measured via visual analog scale. [ Time Frame: Month 3 ]
  44. Maximum pain over the last 8 days measured via visual analog scale. [ Time Frame: Month 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426970


Locations
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France
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, France, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Study Director: Arnaud Dupeyron, MD, PhD Centre Hospitalier Universitaire de Nîmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02426970    
Other Study ID Numbers: AOI/2014/AD-01
2014-A01373-44 ( Other Identifier: RCB number )
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms