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

Low Back Pain Clinical Trial

— LORET  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286333
• Other study ID #: ID-RCB 2021-A02371-40
• Status: Recruiting
• Start date: May 30, 2022
• Est. completion date: March 2026

Study information

• Verified date: September 2023
• Source: Fondation Ildys
• Contact: Marion Buyse, PharmD, PhD
• Phone: 0298293447
• Email: marion.buyse[@]ildys.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: March 2026
• Est. primary completion date: June 7, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Recurrence

Locations

Country	Name	City	State
France	Centre de Perharidy	Roscoff

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ildys	Lille Catholic University

Country where clinical trial is conducted

France, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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	Baseline
Secondary	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	Baseline
Secondary	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	Baseline
Secondary	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	3 months after the rehabilitation program
Secondary	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	6 months after the rehabilitation program
Secondary	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	9 months after the rehabilitation program
Secondary	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	12 months after the rehabilitation program
Secondary	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	Baseline
Secondary	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	3 months after the rehabilitation program
Secondary	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	6 months after the rehabilitation program
Secondary	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	9 months after the rehabilitation program
Secondary	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	12 months after the rehabilitation program
Secondary	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	Baseline
Secondary	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	3 months after the rehabilitation program
Secondary	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	6 months after the rehabilitation program
Secondary	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	9 months after the rehabilitation program
Secondary	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	12 months after the rehabilitation program
Secondary	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	Baseline
Secondary	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	3 months after the rehabilitation program
Secondary	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	6 months after the rehabilitation program
Secondary	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	9 months after the rehabilitation program
Secondary	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	12 months after the rehabilitation program
Secondary	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	Baseline
Secondary	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	3 months after the rehabilitation program
Secondary	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	6 months after the rehabilitation program
Secondary	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	9 months after the rehabilitation program
Secondary	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	12 months after the rehabilitation program
Secondary	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	Baseline
Secondary	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	3 months after the rehabilitation program
Secondary	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	6 months after the rehabilitation program
Secondary	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	9 months after the rehabilitation program
Secondary	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	12 months after the rehabilitation program
Secondary	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	Baseline
Secondary	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	3 months after the rehabilitation program
Secondary	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	6 months after the rehabilitation program
Secondary	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	9 months after the rehabilitation program
Secondary	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	12 months after the rehabilitation program
Secondary	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.	Baseline
Secondary	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.	6 months after the rehabilitation program
Secondary	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.	12 months after the rehabilitation program
Secondary	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.	Baseline
Secondary	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.	6 months after the rehabilitation program
Secondary	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.	12 months after the rehabilitation program