SPINE
Comparison of spinal fusion and nonoperative treatment in patients with chronic low back pain: long-term follow-up of three randomized controlled trials
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(6):51 Spine J. 2013 Nov;13(11):1438-48. doi: 10.1016/j.spinee.2013.06.101. Epub 2013 Nov 5Exclusive Author Interview
Dr. Jeremy C.T. Fairbank discusses spinal fusion and nonoperative treatment in patients with chronic low back pain.
473 patients (261 at the long-term follow-up) with chronic low back pain had been randomly allocated to receive either surgical intervention (i.e. spinal fusion) or conservative treatment in three previous randomized controlled trials. The purpose of this study was to compare these two treatment approaches with respect to combined clinical outcomes at a mean follow-up of 11 years. Results indicated that disability on the Oswestry Disability Index (ODI) was similar between groups. When secondary outcomes were subject to an intention-to-treat analysis, no significant differences were observed in any outcome. Similar findings were observed when these outcomes were subject to an as-treated analysis, except for current back status and the proportion of patients with an ODI of 22 or less, for which spinal fusion was superior. These statistical differences, however, were not found to be clinically relevant.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Sí = 1
Incierto = 0,5
No relevante = 0
No = 0
La evaluación de los criterios de información evalúa la transparencia con la que los autores informan de las características metodológicas y del ensayo dentro de la publicación. La evaluación se divide en cinco categorías que se presentan a continuación.
1/4
Randomização
2/4
Medições dos resultados
4/4
Inclusão / Exclusão
2/4
Descrição da terapia
4/4
Estatística
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
El Índice de Fragilidad es una herramienta que ayuda en la interpretación de hallazgos significativos, proporcionando una medida de fuerza para un resultado. El Índice de Fragilidad representa el número de eventos consecutivos que es necesario añadir a un resultado dicotómico para que el hallazgo deje de ser significativo. Un número pequeño representa un hallazgo más débil y un número grande un hallazgo más fuerte.
¿Por qué se necesitaba ahora este estudio?
Previous analyses have found low back pain to be the leading cause of years lived with disability. Currently, controversy exists surrounding the optimal treatment approach for chronic low back pain (cLBP), as many studies comparing operative versus non-operative treatments have found conflicting results and are of varying quality. Before committing to a specific treatment approach, patients presenting with cLBP often question the long-term effects of both options. As most previous studies evaluated outcomes at 1-2 years post-intervention, this study was needed to compare the long-term clinical outcomes (i.e. mean 11 years) associated with operative and non-operative management of cLBP.
¿Cuál era la pregunta principal de la investigación?
What are the long-term clinical outcomes (i.e. mean 11 years) associated with operative and non-operative treatment of chronic low back pain?
¿Cuáles fueron los hallazgos importantes?
- In both groups, mean ODI scores improved from baseline to the long-term follow-up (p<0.05); however, the degree of this improvement was similar in the two groups (p>0.05).
- According to an intention-to-treat analysis, the treatment effect for ODI was -0.7 (95% CI -5.5 to 4.2; p=0.79), whereas an as-treated analysis revealed a treatment effect of -0.8 (95% CI -5.9 to 4.3; p=0.76) at the long-term follow-up.
- At the long-term follow-up, there was no significant difference between groups in back or leg pain, health-related quality of life, frequency of pain medication for the patient's back problem, frequency of back pain, satisfaction with care, global assessment, and work status, regardless whether an intention-to-treat or an as-treated analysis was performed (all p>0.05).
- For the remaining two secondary outcomes, current back status (on an ordinal scale) and the proportion of patients with an ODI of 22 or less, there were no significant differences between groups when an intention-to-treat analysis was performed (p>0.05). Conversely, according to the as-treated analysis, these outcomes significantly favoured the surgical group (both p=0.04).
- For the 170 patients who underwent surgical intervention within the 8-15 year follow-up, 26 received a secondary operation (15%).
- From randomization to the long-term follow-up, 10 patients in the surgical group and 1 patient in the conservative treatment group had died.
¿Qué es lo que más debo recordar?
Disability at a mean follow-up of 11 years was similar whether patients received a surgical or conservative intervention for their low back pain. When secondary outcomes were subject to an intention-to-treat analysis, no significant differences were observed in any outcome. Similar findings were observed when these outcomes were subject to an as-treated analysis, except for current back status (on an ordinal scale) and the proportion of patients with an ODI of 22 or less, in which spinal fusion was favoured. These statistical differences, however, were not found to be clinically relevant.
¿Cómo afectará esto al cuidado de mis pacientes?
Results from this study suggest that, in regions where multidisciplinary and exercise rehabilitation are available, lumbar fusion may not be necessary in the treatment of low back pain. The findings of this study, however, are limited by a potential placebo/natural history effect in both treatment groups and a high drop-out rate, which may have increased the risk for selection bias. Future studies comparing these two treatment approaches for low back pain should take these limitations into consideration.
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