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Completed

NCT Number: NCT02426970

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

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.

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Key information

Conditions

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

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Montpellier - Hôpital Lapeyronie, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: COP-PAIN

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 27, 2015
Registry last updated
Oct 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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