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Completed

NCT Number: NCT00782925

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Self-led exercises

Other

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

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

    Time frame: 12 and 24 months

Secondary outcomes

  1. Recurrences of lower back pain

    Time frame: At baseline, 12 and 24 months after intervention

  2. Delay before a recurrence of lower back pain

    Time frame: At baseline, 12 and 24 months after intervention

  3. Percentage of patients with a chronic lower back pain (sick leave days>3 months)

    Time frame: At baseline, 12 and 24 months after intervention

  4. Lower back function

    Time frame: At baseline, 12 and 24 months after intervention

  5. Pain : characteristics, intensity (Quebec Back Pain Disability Scale)

    Time frame: At baseline, 12 and 24 months after intervention

  6. Fear-avoidance beliefs(FABQ scale)

    Time frame: At baseline, 12 and 24 months after intervention

  7. Quality of life (SF-12 scale)

    Time frame: At baseline, 12 and 24 months after intervention

  8. Depression and anxiety (HAD scale)

    Time frame: At baseline, 12 and 24 months after intervention

  9. Participant compliance with the global prevention program (self-led exercises)

    Time frame: At 6 and 12 months after intervention

  10. sagittal alignement of the spine (X-ray)

    Time frame: At baseline

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PRESLO

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Oct 31, 2008
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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