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

NCT05286333 | Recruiting DMC

• 1 other identifier: ID-RCB 2021-A02371-40
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (4)

• Recurrence of sick leaves induced by lower back pain

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

  3 months after the rehabilitation program

• Recurrence of sick leaves induced by lower back pain

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

  6 months after the rehabilitation program

• Recurrence of sick leaves induced by lower back pain

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

  9 months after the rehabilitation program

• Recurrence of sick leaves induced by lower back pain

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

  12 months after the rehabilitation program

Secondary Outcomes (43)

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

  Baseline

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

  Baseline

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

  Baseline

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

  3 months after the rehabilitation program

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

  6 months after the rehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ildys: lead
• Lille Catholic University: collaborator

Study Sites (1)

Centre de Perharidy

Roscoff, France

RECRUITING

Related Publications (10)

• 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.

  PMID: 24595187 BACKGROUND

• 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.

  PMID: 26516339 BACKGROUND

• 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.

  PMID: 6450426 BACKGROUND

• 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.

  PMID: 2524890 BACKGROUND

• 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.

  PMID: 31208917 BACKGROUND

• 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.

  PMID: 28355981 BACKGROUND

• 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.

  PMID: 12184438 BACKGROUND

• 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.

  PMID: 3389427 BACKGROUND

• 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.

  PMID: 8455963 BACKGROUND

• 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.

  PMID: 15082995 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean-Sébastien Bourseul, MD

  Fondation Ildys

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Buyse, PharmD, PhD

CONTACT

0298293447; marion.buyse@ildys.org

Matthieu Pichelin

CONTACT

matthieu.pichelin@ildys.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 18, 2022
• Study Start: May 30, 2022
• Primary Completion: June 7, 2023
• Study Completion: March 1, 2026
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)