An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers

NCT ID: NCT00782925

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-02-28

Brief Summary

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At Lyon University Medical Center, back problems are the leading cause of sick leave. The course of lower back pain is usually relatively short (recovery occurs within 4 to 6 weeks in 90% of cases). However, about 5-10% develop chronic lower back pain. Although this is a relatively small group, the economic consequences are enormous (accounting for 70 to 80% of the total cost of lower back pain).

Nowadays, some very general training sessions are offered to workers at Lyon University Medical Center, irrespective of their lower back pain status. These very general training sessions are mostly preventive and primary in nature (like back school program) despite the fact that these people already have a history of lower back pain, the main risk factor of recurrence and chronic pain.

Since the 1980, some multidisciplinary functional restoration programs have been advised as a strategy for secondary and tertiary prevention of lower back pain.

The purpose of this randomized controlled trial is to assess the effectiveness of physical exercise combined with an educational program and self-led exercise for Lyon University Medical Center workers with lower back pain. We hope this intervention will reduce the risk of recurrence and chronic lower back pain.

Detailed Description

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Conditions

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Acute Low Back Pain

Keywords

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Low back pain recurrence chronic low back pain educational program physical therapy home exercise compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Study intervention:

* A face/profile X-ray of their entire spine at baseline
* Educational program
* Exercise program
* Self-led exercises
* A follow-up at 12 and 24 months with their occupational therapist.
* A follow-up at 18 months with a physical therapist.
* Workers received also at the end of the educational program written standardized information about back pain ("the back book", an information booklet) 1.

1. Coudeyre E., Tubach F., Rannou F. \& all, Effect of simple information booklet on pain persistance after an acute episode of low back pain: a non- randomised trial in a primary care setting. PLoS ONE. 2007 ; 2 : e706

Group Type EXPERIMENTAL

educational program

Intervention Type OTHER

Educational program will consist of 1, 2-hour, small-group (8-patient) session with a specialist physician in Physical and Rehablilitation Medecine. Workers will be given information about lower back pain, pain and psychosocial risk factors for persistent or recurrent back-related disability

exercise program

Intervention Type OTHER

The exercise program will consist of 5, 90-minute, small-group (8-patient) sessions with a physical therapist. Healthcare workers will be taught exercises including warm-ups, floor exercises, and endurance training. Only one absence will be allowed, otherwise the worker will be considered as non-compliant.

Self-led exercises

Intervention Type OTHER

Self-led exercises to perform as part of a daily exercise routine

2

Control intervention :

* No intervention
* A face/profile X-ray of their entire spine at baseline
* A follow-up at 12 and 24 months with their occupational therapist,
* A follow-up at 18 months with a physical therapist.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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educational program

Educational program will consist of 1, 2-hour, small-group (8-patient) session with a specialist physician in Physical and Rehablilitation Medecine. Workers will be given information about lower back pain, pain and psychosocial risk factors for persistent or recurrent back-related disability

Intervention Type OTHER

exercise program

The exercise program will consist of 5, 90-minute, small-group (8-patient) sessions with a physical therapist. Healthcare workers will be taught exercises including warm-ups, floor exercises, and endurance training. Only one absence will be allowed, otherwise the worker will be considered as non-compliant.

Intervention Type OTHER

Self-led exercises

Self-led exercises to perform as part of a daily exercise routine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All healthcare workers in the 4 hospital sites
* History of acute or subacute lower back pain in the 3 past years

Exclusion Criteria

* History of surgery for spinal fractures
* History of lumbosacral arthrodesis
* History of surgical intervention or discal hernia, more than 2 levels or more than twice
* Radiculalgia with sign of motor deficit, or radiculalgia with a positive Lasègue sign
* Eligible for enrollement in a functional restoration program for lower back pain
* Ongoing low back pain (lumbago)
* Psychosocial or behavioural impairment
* Unstable cardiac disease
* Inability to fill out the questionnaires and scales (inability to understand French)
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alain BERGERET, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

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France

References

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Denis A, Zelmar A, Le Pogam MA, Chaleat-Valayer E, Bergeret A, Colin C. The PRESLO study: evaluation of a global secondary low back pain prevention program for health care personnel in a hospital setting. Multicenter, randomized intervention trial. BMC Musculoskelet Disord. 2012 Nov 27;13:234. doi: 10.1186/1471-2474-13-234.

Reference Type RESULT
PMID: 23181446 (View on PubMed)

Chaleat-Valayer E, Denis A, Abelin-Genevois K, Zelmar A, Siani-Trebern F, Touzet S, Bergeret A, Colin C, Fassier JB. Long-term effectiveness of an educational and physical intervention for preventing low-back pain recurrence: a randomized controlled trial. Scand J Work Environ Health. 2016 Jun 1;42(6):510-519. doi: 10.5271/sjweh.3597. Epub 2016 Oct 3.

Reference Type RESULT
PMID: 27779639 (View on PubMed)

Other Identifiers

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2008.511

Identifier Type: -

Identifier Source: org_study_id