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

NCT00782925 | Completed DMC

• 1 other identifier: 2008.511
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Other: educational program; Other: exercise program; Other: Self-led exercises

2

NO INTERVENTION

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.

Interventions

educational program 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

1

exercise program 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.

1

Self-led exercises OTHER

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

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69002, France

Location

Related Publications (2)

• 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.

  PMID: 23181446 RESULT

• 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.

  PMID: 27779639 RESULT

MeSH Terms

Conditions

Low Back Pain; Recurrence; Patient Compliance

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alain BERGERET, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)