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

Recruiting

• Conditions: Low Back Pain

• Registration Number: NCT05286333
• Lead Sponsor: Fondation Ildys

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-18
• Study Start: 2022-05-30
• Primary Completion: 2023-06-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of sick leaves induced by lower back pain	12 months after the rehabilitation program	Number of sick leaves induced by lower back pain after the rehabilitation program

Secondary Outcome Measures

Name	Time	Method
Risk factor analysis of recurrence of sick leaves induced by lower back pain (1)	Baseline	demography (sexe and age) will be analysed as risk factor of recurrence
Risk factor analysis of recurrence of sick leaves induced by lower back pain (2)	Baseline	anthropometric data (weight, BMI) will be analysed as risk factor of recurrence
Risk factor analysis of recurrence of sick leaves induced by lower back pain (3)	12 months after the rehabilitation program	quality of life,evaluated by Oswestry scale, will be analysed as risk factor of recurrence
Risk factor analysis of recurrence of sick leaves induced by lower back pain (4)	12 months after the rehabilitation program	Physiological state, evaluated by hospital anxiety and depression scale, will be analysed as risk factor of recurrence
Risk factor analysis of recurrence of sick leaves induced by lower back pain (8)	12 months after the rehabilitation program	stress at work, evaluated with Karasek scale, will be analysed as risk factor of recurrence
Risk factor analysis of recurrence of sick leaves induced by lower back pain (6)	12 months after the rehabilitation program	Pain, evaluated with a visual analog scale, will be analysed as risk factor of recurrence
Risk factor analysis of recurrence of sick leaves induced by lower back pain (7)	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
Risk factor analysis of recurrence of sick leaves induced by lower back pain (5)	12 months after the rehabilitation program	physical activity, evaluated by Ricci \& gagnon questionnaire, will be analysed as risk factor of recurrence
Risk factor analysis of recurrence of sick leaves induced by lower back pain (9)	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
Risk factor analysis of recurrence of sick leaves induced by lower back pain (10)	12 months after the rehabilitation program	locomotor capacity (flexibility and endurance) will be analysed as risk factor of recurrence.
Risk factor analysis of recurrence of sick leaves induced by lower back pain (11)	12 months after the rehabilitation program	neurological impact (tendon reflex) will be analysed as risk factor of recurrence.

Trial Locations

Locations (1)

Centre de Perharidy; 🇫🇷 Roscoff, France