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

An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers: A Randomized, Controlled, 2-year Follow-up Study.

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.

Study Overview

• Status: Completed
• Conditions: Acute Low Back Pain
• Intervention / Treatment: Other: educational program; Other: exercise program; Other: Self-led exercises

• Study Type: Interventional
• Enrollment (Actual): 351
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69002
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.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	Other: 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; 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.; Other: Self-led exercises; Self-led exercises to perform as part of a daily exercise routine
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with recurrence(s) of lower back pain (number of related days of sick leave) over 12 months and 24 months	12 and 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Recurrences of lower back pain	At baseline, 12 and 24 months after intervention
Delay before a recurrence of lower back pain	At baseline, 12 and 24 months after intervention
Percentage of patients with a chronic lower back pain (sick leave days>3 months)	At baseline, 12 and 24 months after intervention
Lower back function	At baseline, 12 and 24 months after intervention
Pain : characteristics, intensity (Quebec Back Pain Disability Scale)	At baseline, 12 and 24 months after intervention
Fear-avoidance beliefs(FABQ scale)	At baseline, 12 and 24 months after intervention
Quality of life (SF-12 scale)	At baseline, 12 and 24 months after intervention
Depression and anxiety (HAD scale)	At baseline, 12 and 24 months after intervention
Participant compliance with the global prevention program (self-led exercises)	At 6 and 12 months after intervention
sagittal alignement of the spine (X-ray)	At baseline

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Alain BERGERET, Pr, Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: October 30, 2008
• First Submitted That Met QC Criteria: October 30, 2008
• First Posted (Estimated): October 31, 2008

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Low back pain; compliance; chronic low back pain; recurrence; educational program; physical therapy; home exercise
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Disease Attributes; Back Pain; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Recurrence; Low Back Pain; Patient Compliance; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training
• Other Study ID Numbers: 2008.511