Effectiveness of three treatment strategies on occupational limitations and quality of life for patients with non-specific chronic low back pain: Is a multidisciplinary approach the key feature to success: study protocol for a randomized controlled trial.

Audrey Petit,Yohann Ronzi,Luc Bontoux,Yves Roquelaure,Valérie Dubus,Ghislaine Roche-Leboucher,Isabelle Richard

doi:10.1186/1471-2474-15-131

Abstract

BackgroundChronic low back pain (cLBP) is a significant public health problem, being the primary cause of work absenteeism, as well as affecting sufferers’ quality of life, in industrialized society. International guidelines recommend intensive multidisciplinary approaches for patients with cLBP. However, these costly and time-consuming programs can only be offered to a minority of the most heavily affected patients and therefore do not seem likely to respond to public health requirements. Lighter programs may be an alternative to full time hospital-based programs with valuable results in terms of disability and occupational activity for cLBP patients. It is therefore important to define both what the determining components of management to improve activity restriction are and how to treat a larger number of patients more effectively at a lower cost. The aim of this study is to compare three programs with various levels of intensity and multidisciplinary.Methods/DesignThis paper describes the protocol for a prospective, randomized, controlled, clinical trial in working aged patients with cLBP. Three treatment strategies are compared: (1) intensive and multidisciplinary program conducted in a rehabilitation center; (2) less intensive outpatient program conducted by a private physiotherapist; (3) mixed strategy combining the same out program with a multidisciplinary intervention. The primary outcome of the trial is the impact of the mixed strategy on being able to work compared to hospital centered-program and out program. The secondary outcome is the impact of the mixed strategy on quality of life and social ability compared to the two others programs. The intervention part of the trial programs will take 5 weeks and observational follow-up will take 12 months. The sample size will be 180 participants (60 for each arm). The project has been approved by the Ethical Committee of Angers Hospital, France.DiscussionOn the hypothesis that a multidisciplinary approach is the key feature to programs success in reducing social and occupational impairment in cLBP patients, we suggest that it is possible to achieve the same results with less intensive strategies if a multidisciplinary approach is maintained.Trial registrationCurrent Controlled Trials NCT02030171.

Highlights

Chronic low back pain is a significant public health problem, being the primary cause of work absenteeism, as well as affecting sufferers’ quality of life, in industrialized society
On the hypothesis that a multidisciplinary approach is the key feature to programs success in reducing social and occupational impairment in Chronic low back pain (cLBP) patients, we suggest that it is possible to achieve the same results with less intensive strategies if a multidisciplinary approach is maintained
This study follows two previous studies by our team: followed up two years after treatment and the results revealed a significant reduction (60%) in the number of days’ sick leave during the two years following inclusion. - The second [22] randomly compared the same Functional Restoration Program (FRP) to less intensive Ambulatory-based Individual Physiotherapy (AIP): 64 patients were included in the FRP arm and 68 patients in the AIP arm

Summary

Introduction

Chronic low back pain (cLBP) is a significant public health problem, being the primary cause of work absenteeism, as well as affecting sufferers’ quality of life, in industrialized society. International Guidelines recommend the use of supervised active exercises, multidisciplinary approaches, cognitive-behavioral therapies and measures of social and professional order for patients with cLBP [1,4,5] Referral for these programs is preferred for patients with cLBP on prolonged sick leave [1,5,6] and treatment management is increasingly focused on the prevention of activity improvement and ability restrictions, and have as an explicit goal return to or staying at work, regardless of changes in the painful condition. Pain outcomes differ between studies, action to improve functional and occupational capacity are consistently encouraging, in France [11,14,16,17,18] These costly and time-consuming intensive multidisciplinary programs can only be offered to a minority of the most heavily affected patients and do not seem likely to respond to public health requirements

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