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

Primary Purpose

Acute Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
educational program
exercise program
Self-led exercises
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Low Back Pain focused on measuring Low back pain, recurrence, chronic low back pain, educational program, physical therapy, home exercise, compliance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

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. 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

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.

Outcomes

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

Secondary Outcome Measures

Recurrences of lower back pain
Delay before a recurrence of lower back pain
Percentage of patients with a chronic lower back pain (sick leave days>3 months)
Lower back function
Pain : characteristics, intensity (Quebec Back Pain Disability Scale)
Fear-avoidance beliefs(FABQ scale)
Quality of life (SF-12 scale)
Depression and anxiety (HAD scale)
Participant compliance with the global prevention program (self-led exercises)
sagittal alignement of the spine (X-ray)

Full Information

First Posted
October 30, 2008
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00782925
Brief Title
An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers
Acronym
PRESLO
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Low Back Pain
Keywords
Low back pain, recurrence, chronic low back pain, educational program, physical therapy, home exercise, compliance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
351 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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. 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
Arm Title
2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
educational program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
exercise program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Self-led exercises
Intervention Description
Self-led exercises to perform as part of a daily exercise routine
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Recurrences of lower back pain
Time Frame
At baseline, 12 and 24 months after intervention
Title
Delay before a recurrence of lower back pain
Time Frame
At baseline, 12 and 24 months after intervention
Title
Percentage of patients with a chronic lower back pain (sick leave days>3 months)
Time Frame
At baseline, 12 and 24 months after intervention
Title
Lower back function
Time Frame
At baseline, 12 and 24 months after intervention
Title
Pain : characteristics, intensity (Quebec Back Pain Disability Scale)
Time Frame
At baseline, 12 and 24 months after intervention
Title
Fear-avoidance beliefs(FABQ scale)
Time Frame
At baseline, 12 and 24 months after intervention
Title
Quality of life (SF-12 scale)
Time Frame
At baseline, 12 and 24 months after intervention
Title
Depression and anxiety (HAD scale)
Time Frame
At baseline, 12 and 24 months after intervention
Title
Participant compliance with the global prevention program (self-led exercises)
Time Frame
At 6 and 12 months after intervention
Title
sagittal alignement of the spine (X-ray)
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain BERGERET, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27779639
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.
Results Reference
result
PubMed Identifier
23181446
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.
Results Reference
derived

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

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