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Low Back PainCOP-PAINNCT02426970

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

An observational study of Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Low Back Pain
How many people
100 participants
Where
2 sitesFrance
Study dates
3 Apr 2017to 8 Apr 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHRU de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

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.

Read the detailed description

The secondary objectives are:

  1. 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.
  2. To describe the kinetics of changes in various parameters (acceptance, coping, avoidance, understanding, anxiety and depression, quality of life, ODI) over 6 months.
  3. To evaluate the agreement between two methods of questionnaire presentation: Paper collection versus collection by Tablet PC.
Conditions
Low Back Pain
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02426970
Study groupRoleWhat they receive
Lumbar spine pain inpatientsThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. Acceptation and Action Questionnaire - II (AAQ-II) score

    Measured: Day -7 (inclusion)

Secondary outcomes (44)

  1. the AAQ-II Score

    Measured: Day 0

  2. the AAQ-II Score

    Measured: Month 1

  3. the AAQ-II Score

    Measured: Month 3

  4. the AAQ-II Score

    Measured: Month 6

  5. Oswestry Disability Index

    Measured: Day -7

  6. Oswestry Disability Index

    Measured: Day 0

  7. Oswestry Disability Index

    Measured: Month 1

  8. Oswestry Disability Index

    Measured: Month 3

  9. Oswestry Disability Index

    Measured: Month 6

  10. Coping Strategies Questionnaire in French (CSQ-F)

    Measured: Day -7

  11. Coping Strategies Questionnaire in French (CSQ-F)

    Measured: Day 0

  12. Coping Strategies Questionnaire in French (CSQ-F)

    Measured: Month 1

  13. Coping Strategies Questionnaire in French (CSQ-F)

    Measured: Month 3

  14. Coping Strategies Questionnaire in French (CSQ-F)

    Measured: Month 6

  15. The Back Beliefs Questionnaire

    Measured: Day -7

  16. The Back Beliefs Questionnaire

    Measured: Day 0

  17. The Back Beliefs Questionnaire

    Measured: Month 1

  18. The Back Beliefs Questionnaire

    Measured: Month 3

  19. The Back Beliefs Questionnaire

    Measured: Month 6

  20. The Fear-Avoidance Beliefs Questionnaire

    Measured: Day -7

  21. The Fear-Avoidance Beliefs Questionnaire

    Measured: Day 0

  22. The Fear-Avoidance Beliefs Questionnaire

    Measured: Month 1

  23. The Fear-Avoidance Beliefs Questionnaire

    Measured: Month 3

  24. The Fear-Avoidance Beliefs Questionnaire

    Measured: Month 6

  25. The Hospital Anxiety and Depression Scale

    Measured: Day -7

  26. The Hospital Anxiety and Depression Scale

    Measured: Day -0

  27. The Hospital Anxiety and Depression Scale

    Measured: Month 1

  28. The Hospital Anxiety and Depression Scale

    Measured: Month 3

  29. The Hospital Anxiety and Depression Scale

    Measured: Month 6

  30. The SF-12 questionnaire

    Measured: Day -7

  31. The SF-12 questionnaire

    Measured: Day 0

  32. The SF-12 questionnaire

    Measured: Month 1

  33. The SF-12 questionnaire

    Measured: Month 3

  34. The SF-12 questionnaire

    Measured: Month 6

  35. Average pain over the last 8 days measured via visual analog scale.

    Measured: Day -7

  36. Average pain over the last 8 days measured via visual analog scale.

    Measured: Day 0

  37. Average pain over the last 8 days measured via visual analog scale.

    Measured: Month 1

  38. Average pain over the last 8 days measured via visual analog scale.

    Measured: Month 3

  39. Average pain over the last 8 days measured via visual analog scale.

    Measured: Month 6

  40. Maximum pain over the last 8 days measured via visual analog scale.

    Measured: Day -7

  41. Maximum pain over the last 8 days measured via visual analog scale.

    Measured: Day 0

  42. Maximum pain over the last 8 days measured via visual analog scale.

    Measured: Month 1

  43. Maximum pain over the last 8 days measured via visual analog scale.

    Measured: Month 3

  44. Maximum pain over the last 8 days measured via visual analog scale.

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2015 (estimated)
  2. Study start3 Apr 2017
  3. Primary completion8 Apr 2019
  4. Study completion8 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02426970
Sponsor's protocol ID
AOI/2014/AD-01
Other IDs
2014-A01373-44
Acronym
COP-PAIN
Status last verified
Oct 2019
First submitted
20 Apr 2015
Last updated
24 Oct 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Classification of the patient as a responder or a non responder (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02426970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.

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