An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers (PRESLO)
|ClinicalTrials.gov Identifier: NCT00782925|
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : December 2, 2014
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 or disease||Intervention/treatment||Phase|
|Acute Low Back Pain||Other: educational program Other: exercise program Other: Self-led exercises||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||351 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||October 2008|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
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 :
- 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 ]
- Recurrences of lower back pain [ Time Frame: At baseline, 12 and 24 months after intervention ]
- Delay before a recurrence of lower back pain [ Time Frame: At baseline, 12 and 24 months after intervention ]
- Percentage of patients with a chronic lower back pain (sick leave days>3 months) [ Time Frame: At baseline, 12 and 24 months after intervention ]
- Lower back function [ Time Frame: At baseline, 12 and 24 months after intervention ]
- Pain : characteristics, intensity (Quebec Back Pain Disability Scale) [ Time Frame: At baseline, 12 and 24 months after intervention ]
- Fear-avoidance beliefs(FABQ scale) [ Time Frame: At baseline, 12 and 24 months after intervention ]
- Quality of life (SF-12 scale) [ Time Frame: At baseline, 12 and 24 months after intervention ]
- Depression and anxiety (HAD scale) [ Time Frame: At baseline, 12 and 24 months after intervention ]
- Participant compliance with the global prevention program (self-led exercises) [ Time Frame: At 6 and 12 months after intervention ]
- sagittal alignement of the spine (X-ray) [ Time Frame: At baseline ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782925
|Hospices Civils de Lyon|
|Lyon, France, 69002|
|Principal Investigator:||Alain BERGERET, Pr||Hospices Civils de Lyon|