Clinical trial NCT00782925: An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Low Back Pain
Keywords: Low back pain
recurrence
chronic low back pain
educational program
physical therapy
home exercise
compliance
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with recurrence(s) of lower back pain (number of related days of sick leave) over 12 months and 24 months
timeFrame: 12 and 24 months
Secondary outcomes:
measure: Recurrences of lower back pain
timeFrame: At baseline, 12 and 24 months after intervention
measure: Delay before a recurrence of lower back pain
timeFrame: At baseline, 12 and 24 months after intervention
measure: Percentage of patients with a chronic lower back pain (sick leave days>3 months)
timeFrame: At baseline, 12 and 24 months after intervention
measure: Lower back function
timeFrame: At baseline, 12 and 24 months after intervention
measure: Pain : characteristics, intensity (Quebec Back Pain Disability Scale)
timeFrame: At baseline, 12 and 24 months after intervention
measure: Fear-avoidance beliefs(FABQ scale)
timeFrame: At baseline, 12 and 24 months after intervention
measure: Quality of life (SF-12 scale)
timeFrame: At baseline, 12 and 24 months after intervention
measure: Depression and anxiety (HAD scale)
timeFrame: At baseline, 12 and 24 months after intervention
measure: Participant compliance with the global prevention program (self-led exercises)
timeFrame: At 6 and 12 months after intervention
measure: sagittal alignement of the spine (X-ray)
timeFrame: At baseline
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Alain BERGERET, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.