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Acute Low Back PainPRESLONCT00782925

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

A study testing educational program, exercise program and Self-led exercises in people with Acute Low Back Pain, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acute Low Back Pain
What is being tested?
educational program, exercise program and Self-led exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
351 participants
Where
1 siteFrance
Study dates
Oct 2008to Feb 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 10Show fewer
  • Psychosocial or behavioural impairment
  • Unstable cardiac disease
  • Inability to fill out the questionnaires and scales (inability to understand French)
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hospices Civils de Lyon

    Lyon, 69002

Other trials in France

About this study

Official 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.

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.

Read more

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.

Being tested
educational program, exercise program, Self-led exercises
Keywords
Low back pain, recurrence, chronic low back pain, educational program, physical therapy, home exercise, compliance
Medical subject headings
Low Back Pain, Recurrence, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • educational programOther

    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 programOther

    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 exercisesOther

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

Study groups in NCT00782925
Study groupRoleWhat they receive
1ExperimentalStudy 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
Receives: Other: educational program; Other: exercise program; Other: Self-led exercises
2No interventionControl 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with recurrence(s) of lower back pain (number of related days of sick leave) over 12 months and 24 months

    Measured: 12 and 24 months

Secondary outcomes (10)

  1. Recurrences of lower back pain

    Measured: At baseline, 12 and 24 months after intervention

  2. Delay before a recurrence of lower back pain

    Measured: At baseline, 12 and 24 months after intervention

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

    Measured: At baseline, 12 and 24 months after intervention

  4. Lower back function

    Measured: At baseline, 12 and 24 months after intervention

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

    Measured: At baseline, 12 and 24 months after intervention

  6. Fear-avoidance beliefs(FABQ scale)

    Measured: At baseline, 12 and 24 months after intervention

  7. Quality of life (SF-12 scale)

    Measured: At baseline, 12 and 24 months after intervention

  8. Depression and anxiety (HAD scale)

    Measured: At baseline, 12 and 24 months after intervention

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

    Measured: At 6 and 12 months after intervention

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

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00782925
Sponsor's protocol ID
2008.511
Acronym
PRESLO
Status last verified
Dec 2025
First submitted
30 Oct 2008
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23181446

  • 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.

    PubMed 27779639

Questions about this trial

What is this clinical trial studying?

A study testing educational program, exercise program and Self-led exercises in people with Acute Low Back Pain, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00782925, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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