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Trial record 2 of 1388 for:    Back Pain
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An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers (PRESLO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00782925
First received: October 30, 2008
Last updated: March 8, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention
Acute Low Back Pain
 Other: educational program
Other: exercise program
Other: Self-led exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 650
Study Start Date: October 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782925

Contacts
Contact: Emmanuelle CHALEAT-VALAYER, MD +33 472.38.46.28 chaleat-valayer.e@cmcr-massues.com

Locations
France
Hospices Civils de Lyon Recruiting
Lyon, France, 69002
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Alain BERGERET, Pr Hospices Civils de Lyon
  More Information

No publications provided by Hospices Civils de Lyon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pr. Alain Bergeret, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00782925     History of Changes
Other Study ID Numbers: 2008.511
Study First Received: October 30, 2008
Last Updated: March 8, 2010
Health Authority: France: Direction Générale de la Santé

Keywords provided by Hospices Civils de Lyon:
Low back pain
recurrence
chronic low back pain
educational program
 physical therapy
home exercise
compliance

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013