AzTrials
AzTrials

Low Back PainLORETNCT05286333

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

An observational study of Low Back Pain, run by Fondation Ildys at 1 site in France.

Completed

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Back Pain
How many people
51 participants
Where
1 siteFrance
Study dates
30 May 2022to 1 Apr 2026
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 years and older
  • All sexes
  • Adult, Older adult

Study population: All the beneficiaries of the multidisciplinary follow-up shared between the physical and rehabilitation medicine and occupational medicine, will be elligible in this study.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre de Perharidy

    Roscoff

Other trials in France

About this study

Official 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

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.

Read more

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.

Conditions
Low Back Pain
Medical subject headings
Low Back Pain

What is being measured

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

  1. Recurrence of sick leaves induced by lower back pain

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

    Measured: 3 months after the rehabilitation program

  2. Recurrence of sick leaves induced by lower back pain

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

    Measured: 6 months after the rehabilitation program

  3. Recurrence of sick leaves induced by lower back pain

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

    Measured: 9 months after the rehabilitation program

  4. Recurrence of sick leaves induced by lower back pain

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

    Measured: 12 months after the rehabilitation program

Secondary outcomes (43)

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

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

    Measured: Baseline

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

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

    Measured: Baseline

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

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

    Measured: Baseline

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

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

    Measured: 3 months after the rehabilitation program

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

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

    Measured: 6 months after the rehabilitation program

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

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

    Measured: 9 months after the rehabilitation program

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

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

    Measured: 12 months after the rehabilitation program

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

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

    Measured: Baseline

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

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

    Measured: 3 months after the rehabilitation program

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

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

    Measured: 6 months after the rehabilitation program

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

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

    Measured: 9 months after the rehabilitation program

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

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

    Measured: 12 months after the rehabilitation program

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

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

    Measured: Baseline

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

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

    Measured: 3 months after the rehabilitation program

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

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

    Measured: 6 months after the rehabilitation program

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

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

    Measured: 9 months after the rehabilitation program

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

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

    Measured: 12 months after the rehabilitation program

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

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

    Measured: Baseline

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

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

    Measured: 3 months after the rehabilitation program

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

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

    Measured: 6 months after the rehabilitation program

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

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

    Measured: 9 months after the rehabilitation program

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

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

    Measured: 12 months after the rehabilitation program

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

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

    Measured: Baseline

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

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

    Measured: 3 months after the rehabilitation program

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

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

    Measured: 6 months after the rehabilitation program

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

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

    Measured: 9 months after the rehabilitation program

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

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

    Measured: 12 months after the rehabilitation program

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

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

    Measured: Baseline

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

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

    Measured: 3 months after the rehabilitation program

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

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

    Measured: 6 months after the rehabilitation program

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

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

    Measured: 9 months after the rehabilitation program

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

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

    Measured: 12 months after the rehabilitation program

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

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

    Measured: Baseline

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

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

    Measured: 3 months after the rehabilitation program

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

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

    Measured: 6 months after the rehabilitation program

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

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

    Measured: 9 months after the rehabilitation program

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

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

    Measured: 12 months after the rehabilitation program

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

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

    Measured: Baseline

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

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

    Measured: 6 months after the rehabilitation program

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

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

    Measured: 12 months after the rehabilitation program

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

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

    Measured: Baseline

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

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

    Measured: 6 months after the rehabilitation program

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

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

    Measured: 12 months after the rehabilitation program

Timeline

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

  1. First posted18 Mar 2022
  2. Study start30 May 2022
  3. Primary completion1 Apr 2026
  4. Study completion1 Apr 2026

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
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05286333
Sponsor's protocol ID
ID-RCB 2021-A02371-40
Acronym
LORET
Status last verified
Jul 2025
First submitted
25 Feb 2022
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Palazzo C, Ravaud JF, Papelard A, Ravaud P, Poiraudeau S. The burden of musculoskeletal conditions. PLoS One. 2014 Mar 4;9(3):e90633. doi: 10.1371/journal.pone.0090633. eCollection 2014.

    PubMed 24595187

  • Cougot B, Petit A, Paget C, Roedlich C, Fleury-Bahi G, Fouquet M, Menu P, Dubois C, Geraut C, Roquelaure Y, Tripodi D. Chronic low back pain among French healthcare workers and prognostic factors of return to work (RTW): a non-randomized controlled trial. J Occup Med Toxicol. 2015 Oct 29;10:40. doi: 10.1186/s12995-015-0082-5. eCollection 2015.

    PubMed 26516339

  • Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.

    PubMed 6450426

  • Lawlis GF, Cuencas R, Selby D, McCoy CE. The development of the Dallas Pain Questionnaire. An assessment of the impact of spinal pain on behavior. Spine (Phila Pa 1976). 1989 May;14(5):511-6. doi: 10.1097/00007632-198905000-00007.

    PubMed 2524890

  • da Silva T, Mills K, Brown BT, Pocovi N, de Campos T, Maher C, Hancock MJ. Recurrence of low back pain is common: a prospective inception cohort study. J Physiother. 2019 Jul;65(3):159-165. doi: 10.1016/j.jphys.2019.04.010. Epub 2019 Jun 14.

    PubMed 31208917

  • da Silva T, Mills K, Brown BT, Herbert RD, Maher CG, Hancock MJ. Risk of Recurrence of Low Back Pain: A Systematic Review. J Orthop Sports Phys Ther. 2017 May;47(5):305-313. doi: 10.2519/jospt.2017.7415. Epub 2017 Mar 29.

    PubMed 28355981

  • Yvanes-Thomas M, Calmels P, Bethoux F, Richard A, Nayme P, Payre D, Laurent B. Validity of the French-language version of the Quebec back pain disability scale in low back pain patients in France. Joint Bone Spine. 2002 Jun;69(4):397-405. doi: 10.1016/s1297-319x(02)00415-3.

    PubMed 12184438

  • Karasek RA, Theorell T, Schwartz JE, Schnall PL, Pieper CF, Michela JL. Job characteristics in relation to the prevalence of myocardial infarction in the US Health Examination Survey (HES) and the Health and Nutrition Examination Survey (HANES). Am J Public Health. 1988 Aug;78(8):910-8. doi: 10.2105/ajph.78.8.910.

    PubMed 3389427

  • Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.

    PubMed 8455963

  • Chaory K, Fayad F, Rannou F, Lefevre-Colau MM, Fermanian J, Revel M, Poiraudeau S. Validation of the French version of the fear avoidance belief questionnaire. Spine (Phila Pa 1976). 2004 Apr 15;29(8):908-13. doi: 10.1097/00007632-200404150-00018.

    PubMed 15082995

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain, run by Fondation Ildys at 1 site 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 6 inclusion and 6 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 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Recurrence of sick leaves induced by lower back pain (time frame: 3 months after the rehabilitation program). The study lists 4 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 NCT05286333, which also lists 10 linked publications.

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 28 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in