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

Acute Low Back Pain Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782925
• Other study ID #: 2008.511
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: February 2014

Study information

• Verified date: December 2014
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Low Back Pain
• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Chaléat-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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with recurrence(s) of lower back pain (number of related days of sick leave) over 12 months and 24 months		12 and 24 months
Secondary	Recurrences of lower back pain		At baseline, 12 and 24 months after intervention
Secondary	Delay before a recurrence of lower back pain		At baseline, 12 and 24 months after intervention
Secondary	Percentage of patients with a chronic lower back pain (sick leave days>3 months)		At baseline, 12 and 24 months after intervention
Secondary	Lower back function		At baseline, 12 and 24 months after intervention
Secondary	Pain : characteristics, intensity (Quebec Back Pain Disability Scale)		At baseline, 12 and 24 months after intervention
Secondary	Fear-avoidance beliefs(FABQ scale)		At baseline, 12 and 24 months after intervention
Secondary	Quality of life (SF-12 scale)		At baseline, 12 and 24 months after intervention
Secondary	Depression and anxiety (HAD scale)		At baseline, 12 and 24 months after intervention
Secondary	Participant compliance with the global prevention program (self-led exercises)		At 6 and 12 months after intervention
Secondary	sagittal alignement of the spine (X-ray)		At baseline