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OpenTrials
Completed

NCT Number: NCT05286333

Identification of Risk Factors for Recurrence of Low Back Pain and Occupational Repercussions

Low back pain (LBP) is the leading cause of disability and one of the most common reasons for physician visits in primary care, with a 33 % rate of recurrence during the first year, converting LBP into a chronic condition.

The french High healthy authority recommend early occupational oriented intervention associated with a multidisciplinary rehabilitation program.

However even if these recommendations are taken into appropriate account, risk for recurrence of Low back pain and occupational repercussions often occured.

This study aims to identify the risk factor(s) of sick leave after a rehabilitation stay in outpatients and thus adapt cares provided to the patients in respect of their needs and expectations.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de Perharidy

Roscoff, France

Who can participate

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

Inclusion criteria

  • men and women over 18 years old
  • able to understand and respect the protocol requirement
  • who signed the consent prior to any other procedure protocol
  • patients suffering from chronic lower back or lumbo-radicular pain since more than 3 months
  • employee bellow 3 years before retirement
  • patients included in a multidisciplinary rehabilitation program and occupational medicine

Exclusion criteria

  • major patients under guardianship/curator/legal protection
  • pregnant patients
  • obese patients with BMI (body mass index) > 35 (grade 2)
  • patients suffering from neurological pathology
  • patients suffering from chronic lower back or lumbo-radicular pain since less than 3 months
  • patients suffering from chronic lower back pain with inflammatory or tumoral or infectious ethiology

Treatment and study plan

Primary outcomes

  1. Recurrence of sick leaves induced by lower back pain

    Time frame: 3 months after the rehabilitation program

    Number of sick leaves induced by lower back pain after the rehabilitation program

  2. Recurrence of sick leaves induced by lower back pain

    Time frame: 6 months after the rehabilitation program

    Number of sick leaves induced by lower back pain after the rehabilitation program

  3. Recurrence of sick leaves induced by lower back pain

    Time frame: 9 months after the rehabilitation program

    Number of sick leaves induced by lower back pain after the rehabilitation program

  4. Recurrence of sick leaves induced by lower back pain

    Time frame: 12 months after the rehabilitation program

    Number of sick leaves induced by lower back pain after the rehabilitation program

Secondary outcomes

  1. Risk factor analysis of recurrence of sick leaves induced by lower back pain (1)

    Time frame: Baseline

    demography (sexe and age) will be analysed as risk factor of recurrence

  2. Risk factor analysis of recurrence of sick leaves induced by lower back pain (2)

    Time frame: Baseline

    anthropometric data (weight, BMI) will be analysed as risk factor of recurrence

  3. Risk factor analysis of recurrence of sick leaves induced by lower back pain (3)

    Time frame: Baseline

    quality of life,evaluated by Oswestry scale, will be analysed as risk factor of recurrence

  4. Risk factor analysis of recurrence of sick leaves induced by lower back pain (3)

    Time frame: 3 months after the rehabilitation program

    quality of life,evaluated by Oswestry scale, will be analysed as risk factor of recurrence

  5. Risk factor analysis of recurrence of sick leaves induced by lower back pain (3)

    Time frame: 6 months after the rehabilitation program

    quality of life,evaluated by Oswestry scale, will be analysed as risk factor of recurrence

  6. Risk factor analysis of recurrence of sick leaves induced by lower back pain (3)

    Time frame: 9 months after the rehabilitation program

    quality of life,evaluated by Oswestry scale, will be analysed as risk factor of recurrence

  7. Risk factor analysis of recurrence of sick leaves induced by lower back pain (3)

    Time frame: 12 months after the rehabilitation program

    quality of life,evaluated by Oswestry scale, will be analysed as risk factor of recurrence

  8. Risk factor analysis of recurrence of sick leaves induced by lower back pain (4)

    Time frame: Baseline

    Physiological state, evaluated by hospital anxiety and depression scale, will be analysed as risk factor of recurrence

  9. Risk factor analysis of recurrence of sick leaves induced by lower back pain (4)

    Time frame: 3 months after the rehabilitation program

    Physiological state, evaluated by hospital anxiety and depression scale, will be analysed as risk factor of recurrence

  10. Risk factor analysis of recurrence of sick leaves induced by lower back pain (4)

    Time frame: 6 months after the rehabilitation program

    Physiological state, evaluated by hospital anxiety and depression scale, will be analysed as risk factor of recurrence

  11. Risk factor analysis of recurrence of sick leaves induced by lower back pain (4)

    Time frame: 9 months after the rehabilitation program

    Physiological state, evaluated by hospital anxiety and depression scale, will be analysed as risk factor of recurrence

  12. Risk factor analysis of recurrence of sick leaves induced by lower back pain (4)

    Time frame: 12 months after the rehabilitation program

    Physiological state, evaluated by hospital anxiety and depression scale, will be analysed as risk factor of recurrence

  13. Risk factor analysis of recurrence of sick leaves induced by lower back pain (5)

    Time frame: Baseline

    physical activity, evaluated by Ricci & gagnon questionnaire, will be analysed as risk factor of recurrence

  14. Risk factor analysis of recurrence of sick leaves induced by lower back pain (5)

    Time frame: 3 months after the rehabilitation program

    physical activity, evaluated by Ricci & gagnon questionnaire, will be analysed as risk factor of recurrence

  15. Risk factor analysis of recurrence of sick leaves induced by lower back pain (5)

    Time frame: 6 months after the rehabilitation program

    physical activity, evaluated by Ricci & gagnon questionnaire, will be analysed as risk factor of recurrence

  16. Risk factor analysis of recurrence of sick leaves induced by lower back pain (5)

    Time frame: 9 months after the rehabilitation program

    physical activity, evaluated by Ricci & gagnon questionnaire, will be analysed as risk factor of recurrence

  17. Risk factor analysis of recurrence of sick leaves induced by lower back pain (5)

    Time frame: 12 months after the rehabilitation program

    physical activity, evaluated by Ricci & gagnon questionnaire, will be analysed as risk factor of recurrence

  18. Risk factor analysis of recurrence of sick leaves induced by lower back pain (6)

    Time frame: Baseline

    Pain, evaluated with a visual analog scale, will be analysed as risk factor of recurrence

  19. Risk factor analysis of recurrence of sick leaves induced by lower back pain (6)

    Time frame: 3 months after the rehabilitation program

    Pain, evaluated with a visual analog scale, will be analysed as risk factor of recurrence

  20. Risk factor analysis of recurrence of sick leaves induced by lower back pain (6)

    Time frame: 6 months after the rehabilitation program

    Pain, evaluated with a visual analog scale, will be analysed as risk factor of recurrence

  21. Risk factor analysis of recurrence of sick leaves induced by lower back pain (6)

    Time frame: 9 months after the rehabilitation program

    Pain, evaluated with a visual analog scale, will be analysed as risk factor of recurrence

  22. Risk factor analysis of recurrence of sick leaves induced by lower back pain (6)

    Time frame: 12 months after the rehabilitation program

    Pain, evaluated with a visual analog scale, will be analysed as risk factor of recurrence

  23. Risk factor analysis of recurrence of sick leaves induced by lower back pain (7)

    Time frame: Baseline

    Impact of lower back pain on wellbeing, evaluated with Dallas questionnaire, will be analysed as risk factor of recurrence

  24. Risk factor analysis of recurrence of sick leaves induced by lower back pain (7)

    Time frame: 3 months after the rehabilitation program

    Impact of lower back pain on wellbeing, evaluated with Dallas questionnaire, will be analysed as risk factor of recurrence

  25. Risk factor analysis of recurrence of sick leaves induced by lower back pain (7)

    Time frame: 6 months after the rehabilitation program

    Impact of lower back pain on wellbeing, evaluated with Dallas questionnaire, will be analysed as risk factor of recurrence

  26. Risk factor analysis of recurrence of sick leaves induced by lower back pain (7)

    Time frame: 9 months after the rehabilitation program

    Impact of lower back pain on wellbeing, evaluated with Dallas questionnaire, will be analysed as risk factor of recurrence

  27. Risk factor analysis of recurrence of sick leaves induced by lower back pain (7)

    Time frame: 12 months after the rehabilitation program

    Impact of lower back pain on wellbeing, evaluated with Dallas questionnaire, will be analysed as risk factor of recurrence

  28. Risk factor analysis of recurrence of sick leaves induced by lower back pain (8)

    Time frame: Baseline

    stress at work, evaluated with Karasek scale, will be analysed as risk factor of recurrence

  29. Risk factor analysis of recurrence of sick leaves induced by lower back pain (8)

    Time frame: 3 months after the rehabilitation program

    stress at work, evaluated with Karasek scale, will be analysed as risk factor of recurrence

  30. Risk factor analysis of recurrence of sick leaves induced by lower back pain (8)

    Time frame: 6 months after the rehabilitation program

    stress at work, evaluated with Karasek scale, will be analysed as risk factor of recurrence

  31. Risk factor analysis of recurrence of sick leaves induced by lower back pain (8)

    Time frame: 9 months after the rehabilitation program

    stress at work, evaluated with Karasek scale, will be analysed as risk factor of recurrence

  32. Risk factor analysis of recurrence of sick leaves induced by lower back pain (8)

    Time frame: 12 months after the rehabilitation program

    stress at work, evaluated with Karasek scale, will be analysed as risk factor of recurrence

  33. Risk factor analysis of recurrence of sick leaves induced by lower back pain (9)

    Time frame: Baseline

    Fear and beliefs, evaluated with FABQ (Fear-avoidance beliefs questionnaire) scale, will be analysed as risk factor of recurrence

  34. Risk factor analysis of recurrence of sick leaves induced by lower back pain (9)

    Time frame: 3 months after the rehabilitation program

    Fear and beliefs, evaluated with FABQ (Fear-avoidance beliefs questionnaire) scale, will be analysed as risk factor of recurrence

  35. Risk factor analysis of recurrence of sick leaves induced by lower back pain (9)

    Time frame: 6 months after the rehabilitation program

    Fear and beliefs, evaluated with FABQ (Fear-avoidance beliefs questionnaire) scale, will be analysed as risk factor of recurrence

  36. Risk factor analysis of recurrence of sick leaves induced by lower back pain (9)

    Time frame: 9 months after the rehabilitation program

    Fear and beliefs, evaluated with FABQ (Fear-avoidance beliefs questionnaire) scale, will be analysed as risk factor of recurrence

  37. Risk factor analysis of recurrence of sick leaves induced by lower back pain (9)

    Time frame: 12 months after the rehabilitation program

    Fear and beliefs, evaluated with FABQ (Fear-avoidance beliefs questionnaire) scale, will be analysed as risk factor of recurrence

  38. Risk factor analysis of recurrence of sick leaves induced by lower back pain (10)

    Time frame: Baseline

    locomotor capacity (flexibility and endurance) will be analysed as risk factor of recurrence.

  39. Risk factor analysis of recurrence of sick leaves induced by lower back pain (10)

    Time frame: 6 months after the rehabilitation program

    locomotor capacity (flexibility and endurance) will be analysed as risk factor of recurrence.

  40. Risk factor analysis of recurrence of sick leaves induced by lower back pain (10)

    Time frame: 12 months after the rehabilitation program

    locomotor capacity (flexibility and endurance) will be analysed as risk factor of recurrence.

  41. Risk factor analysis of recurrence of sick leaves induced by lower back pain (11)

    Time frame: Baseline

    neurological impact (tendon reflex) will be analysed as risk factor of recurrence.

  42. Risk factor analysis of recurrence of sick leaves induced by lower back pain (11)

    Time frame: 6 months after the rehabilitation program

    neurological impact (tendon reflex) will be analysed as risk factor of recurrence.

  43. Risk factor analysis of recurrence of sick leaves induced by lower back pain (11)

    Time frame: 12 months after the rehabilitation program

    neurological impact (tendon reflex) will be analysed as risk factor of recurrence.

Sponsors and collaborators

Lead sponsor

Fondation Ildys

Other

Collaborators

  • Lille Catholic University

Registry information

Official study title

Identification of Risk Factors for Recurrence of Low Back Pain and Occupational Repercussions Among Beneficiaries of a Multidisciplinary Follow-up Shared Between Physical and Rehabilitation Medicine and Occupational Medicine: a Monocentric Prospective Study

Acronym: LORET

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2022
Registry last updated
Aug 28, 2026

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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