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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00782925
First received: October 30, 2008
Last updated: March 4, 2014
Last verified: March 2014

October 30, 2008
March 4, 2014
October 2008
February 2014   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00782925 on ClinicalTrials.gov Archive Site
  • Recurrences of lower back pain [ Time Frame: At baseline, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Delay before a recurrence of lower back pain [ Time Frame: At baseline, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Percentage of patients with a chronic lower back pain (sick leave days>3 months) [ Time Frame: At baseline, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Lower back function [ Time Frame: At baseline, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Pain : characteristics, intensity (Quebec Back Pain Disability Scale) [ Time Frame: At baseline, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Fear-avoidance beliefs(FABQ scale) [ Time Frame: At baseline, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Quality of life (SF-12 scale) [ Time Frame: At baseline, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Depression and anxiety (HAD scale) [ Time Frame: At baseline, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Participant compliance with the global prevention program (self-led exercises) [ Time Frame: At 6 and 12 months after intervention ] [ Designated as safety issue: No ]
  • sagittal alignement of the spine (X-ray) [ Time Frame: At baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Acute Low Back Pain
  • 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
  • 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.

      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
    Interventions:
    • Other: educational program
    • Other: exercise program
    • Other: Self-led exercises
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
351
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00782925
2008.511
Yes
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Principal Investigator: Alain BERGERET, Pr Hospices Civils de Lyon
Hospices Civils de Lyon
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP