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Long-term clinical outcome similar with surgical fusion vs conservative treatment for LBP
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March 2014
Long-term clinical outcome similar with surgical fusion vs conservative treatment for LBP
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
Comparison of spinal fusion and nonoperative treatment in patients with chronic low back pain: long-term follow-up of three randomized controlled trials
Spine J. 2013 Nov;13(11):1438-48. doi: 10.1016/j.spinee.2013.06.101. Epub 2013 Nov 5Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
OE EXCLUSIVE
Dr. Jeremy C.T. Fairbank discusses spinal fusion and nonoperative treatment in patients with chronic low back pain.
Synopsis
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.
Publication Funding Details
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Funding:
Non-Industry funded
Sponsor:
AO Spine, Thames Valley Comprehensive Local Research Network for National Institute for Health Research (UK), Norwegian Research Council (Norway)
Conflicts:
None disclosed
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)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
1/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
2/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
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.
What was the principal research question?
What are the long-term clinical outcomes (i.e. mean 11 years) associated with operative and non-operative treatment of chronic low back pain?
Study Characteristics
-
Population:
473 randomized patients (261 at the long-term follow-up) from three separate randomized controlled trials. Among these studies, two were based in Norway and one in the UK. Patients were included if they (1) presented with low back pain for more than 1 year, and (2) along with the clinician, were uncertain as to which treatment option was best. For patients included in the Norway trial, a disability level of 30/100 on the ODI and degeneration at L4-L5 and/or L5/S1 were required for inclusion. (Mean age: 41.2 +/- 8.3 years; 47.2% male)
Intervention:
Surgical intervention group: Patients randomized to this group (n=242; 140 at final follow-up) underwent spinal fusion/stabilization surgery for their low back pain. In Norway, the specific surgical intervention was posterolateral fusion with transpedicular screws, whereas in the UK, the specific surgical intervention was determined at the surgeon's discretion (i.e. either posterolateral fusion with or without transpedicular screw fixation, anterior lumbar interbody fusion, or posterior lumbar interbody fusion and/or dynamic stabilization).
Comparison:
Conservative management group: Patients randomized to this group (n=231; 121 at final follow-up) underwent multidisciplinary cognitive-behavioural and exercise rehabilitation for their low back pain. The specific protocols were comparable regardless of study country.
Outcomes:
The primary outcome was the Oswestry Disability Index (ODI). Secondary outcomes included: (1) work status (full-time, part-time, or not working), (2) back and leg pain (measured on the Visual Analog Scale [VAS]), (3) health-related quality of life (assessed on the EuroQoL 0-100 VAS), (4) frequency of pain medication taken for back pain, (5) frequency of back pain, (6) global assessment of the degree of improvement in the back problem, (7) global assessment of current back status, and (8) patient satisfaction.
Methods:
RCT; Presenting the combined long-term results of 3 RCTs; Multi Centre
Time:
Mean follow-up was 11 years (range 8-15 years).
What were the important findings?
- 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.
What should I remember most?
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.
How will this affect the care of my patients?
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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