Cochin Hospital
Paris, 75014, France
NCT Number: NCT05261828
The main purpose of this study is to assess the clinical efficiency of an intervention including a short multidisciplinary program of education and rehabilitation and a personalized follow-up, in patients with subacute and chronic low back pain and no severe disability. The secondary objectives are:
* to assess the capacity of the program to modify and reduce the risk factors for evolution of patients towards a severe disability, * to estimate the cost-utility ratio of the intervention.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75014, France
Non-specific low back pain (LBP) is the leading cause of years lived with disability worldwide. Subacute LBP is commonly defined as back pain lasting between 6 weeks and 3 months, chronic LBP as pain that persists for 3 or more months. In its most severe forms, subacute and chronic LBP can lead to severe disability that combines physical and psychological deconditioning, limitations in basic and complex activities of daily living, professional exclusion and social marginalization.
The direct and indirect medical and economic cost of chronic LBP is major for society.
Since the eighties, the bio-psycho-social approach has emerged for the treatment of people with chronic LBP and has led to multidisciplinary functional restoration (FR) programs that include physical activity, exercises, education, occupational therapy and psychological and social rehabilitation. However, the efficiency of these programs is inconsistent and their cost-effectiveness is criticized.
As FR programs are by definition standardized, the treatment of chronic LBP remains poorly stratified. However, interest in stratified therapeutic strategies has recently emerged and shown promising results. To date, in France, only semi-intensive (<100h) or intensive (>100h) FR programs dedicated to severely disabled patients with chronic LBP have been assessed The investigators' main hypothesis is that an intervention consisting in a short multidisciplinary program including education and rehabilitation and a personalized follow-up could reduce the activity limitations of not severely disabled patients with subacute and chronic LBP.
The investigators' secondary hypothesis is that such an intervention could also reduce the main risk factors for evolution of patients with LBP towards a severe disability.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
short multidisciplinary program including education and rehabilitation and a personalized follow-up for patients with subacute and chronic low back pain
Reassuring messages and advices in agreement with current recommendations
Time frame: 3 months
Variation in the level of low back pain- activity limitation assessed by the Roland-Morris self-administered questionnaire (0, no limitation and 24, maximum limitation)
Time frame: 6 and 12 months.
Variation in the level of low back pain activity limitation assessed by the Roland-Morris self-administered questionnaire (0, no limitation and 24, maximum limitation)
Time frame: 3 months
Variation in the level of fears and beliefs about work assessed by the work sub score of the self-administered Fear-Avoidance Beliefs Questionnaire (FABQ) (0, no fears and beliefs and 24, maximum fears and beliefs)
Time frame: 3 months
Variation in the level of fears and beliefs about physical activity assessed by the physical activity sub score of the self-administered Fear-Avoidance Beliefs Questionnaire (FABQ) (FABQ), (0, no fears and beliefs and 42, maximum fears and beliefs)
Time frame: 3 and 12 months
Number of "days off work" reported by the patient
Time frame: 3 months
Variation in the mean intensity of low back pain over the last 48 hours assessed on a self-administered numerical scale (0, no pain and 100,maximum pain)
Time frame: 3 months
Change in mean intensity of radicular pain over the last 48 hours assessed on a self-administered numerical scale (0, no pain and 100,maximum pain)
Time frame: 12 months
Incremental cost-utility ratio
Assistance Publique - Hôpitaux de Paris
Other
Acronym: LOMBAFAST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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