Elsevier

The Spine Journal

Volume 13, Issue 11, November 2013, Pages 1438-1448
The Spine Journal

Clinical Study
Comparison of spinal fusion and nonoperative treatment in patients with chronic low back pain: long-term follow-up of three randomized controlled trials

https://doi.org/10.1016/j.spinee.2013.06.101Get rights and content

Abstract

Background context

Chronic low back pain (cLBP) represents a major challenge to our health care systems. The relative efficacy of surgery over nonoperative treatment for the treatment of cLBP remains controversial, and little is known of the long-term comparative outcomes.

Purpose

To compare the clinical outcome at long-term follow-up (LTFU) of patients who were randomized with either spinal fusion or multidisciplinary cognitive-behavioral and exercise rehabilitation for cLBP.

Study design/setting

Long-term clinical follow-up of three multicenter randomized controlled trials (RCTs) of surgery (instrumented or noninstrumented fusion, stabilization) versus nonoperative treatment (multidisciplinary cognitive-behavioral and exercise rehabilitation) in Norway and the United Kingdom.

Patient sample

A total of 473 patients with cLBP of at least 1 year's duration who were all considered candidates for spinal fusion.

Outcome measures

The primary outcome was the Oswestry Disability Index (ODIv2.1a for the United Kingdom and ODIv1 for Norway) score measured at LTFU. Secondary outcomes included visual analog scale (VAS) pain intensity, pain frequency, pain medication use, work status, EuroQol VAS for health-related quality of life, satisfaction with care, and global treatment outcome at LTFU.

Methods

Patients who consented to LTFU (average 11.4 [range 8–15] years after the initial treatment) completed the outcome questionnaires.

Results

Of 473 enrolled patients, 261 (55%) completed LTFU, 140/242 patients randomized to receive surgery and 121/231 randomized to receive multidisciplinary cognitive-behavioral and exercise rehabilitation. The intention-to-treat analysis showed no statistically or clinically significant differences between treatment groups for ODI scores at LTFU (adjusted for baseline ODI, previous surgery, duration of LBP, sex, age, and smoking habit): the mean adjusted treatment effect of fusion was −0.7 points on the 0–100 ODI scale (95% confidence interval [CI], −5.5 to 4.2). An as-treated analysis similarly demonstrated no advantage of surgery (treatment effect, −0.8 points on the ODI (95% CI, −5.9 to 4.3). The results for the secondary outcomes were largely consistent with those of the ODI, showing no relevant group differences.

Conclusions

After an average of 11 years follow-up, there was no difference in patient self-rated outcomes between fusion and multidisciplinary cognitive-behavioral and exercise rehabilitation for cLBP. The results suggest that, given the increased risks of surgery and the lack of deterioration in nonoperative outcomes over time, the use of lumbar fusion in cLBP patients should not be favored in health care systems where multidisciplinary cognitive-behavioral and exercise rehabilitation programmes are available.

Introduction

Evidence & Methods

Since the classic studies of Fritzell et al., Brox et al., and Fairbanks et al. were published in the early 2000s, there has been considerable controversy over the role of fusion in the treatment of chronic low back pain.

In this long-term follow-up study of three RCTs with an average of 11 years post-treatment, fusion was found to be no better than cognitive behavioral therapy and exercise rehabilitation analyzed both from the intent-to-treat and as-treated perspectives.

The findings at 11 years mirror those reported at two years and, coupled with risks and costs, appropriate nonoperative treatment appears to be the treatment of choice for chronic LBP in places where such treatment can be provided.

Chronic low back pain (cLBP) represents a major challenge to our health care systems. Disc degeneration, an inevitable process of aging and a phenomenon that occurs at variable rates and to variable degrees in different individuals, is considered by some to be one of the major causes of cLBP [1], [2], [3]. The relative efficacy of surgery over nonoperative care for the treatment of cLBP associated with disc degeneration remains controversial. There is limited evidence (level C [based on the classification system described in [4], [5]]) from systematic reviews [4], [5] that in selected patients with severe cLBP and degenerative changes at the lower lumbar levels who have failed to improve with conservative treatment, surgery may be more successful than traditional, nonspecific physiotherapy as far as improvements in functional disability (Oswestry Disability Index [ODI]) and pain 2 years after treatment are concerned. There is moderate evidence (level B) that surgery is similar to multidisciplinary cognitive-behavioral and exercise rehabilitation in improving functional disability (as reflected by the ODI) [4], [5]. Hence, current guidelines (eg, the COST guidelines [4], and NICE: http://www.nice.org.uk/nicemedia/pdf/CG88fullguideline.pdf) generally advocate the use of multidisciplinary cognitive-behavioral and exercise rehabilitation programs as first-line treatments, with fusion surgery being considered if such nonoperative treatments have “failed to improve the condition.” The follow-up period used in the original randomized controlled trials [6], [7], [8], [9] on which the recommendations in current guidelines are based, was just 1–2 years. Five- to 10-year results from the Swedish trial were presented in abstract form only and, contrary to their published 2-year results, showed no difference in outcome between lumbar fusion and traditional physiotherapy treatment in primary care [10]. There is limited evidence from the Norwegian trials that neither treatment is superior to the other in the very long term [11], [12]. In clinical practice, one of the most frequent issues raised by the patient during the preoperative consent process concerns the likely outcome in the long term after surgery, especially as compared with conservative measures. Currently, there are no clear answers to this specific question.

The aim of the present study was to compare the clinical outcome at long-term follow-up (LTFU; average 11 [range 8–15] years) in patients with cLBP who presented as potential candidates for spinal fusion and were randomized to receive either fusion or multidisciplinary cognitive-behavioral and exercise rehabilitation. The data were pooled from three recent European randomized controlled trials (RCTs) [7], [8], [9].

Section snippets

Study design

The study comprised the long-term (average 11 years) clinical follow-up of patients in the surgical and multidisciplinary cognitive-behavioral and exercise rehabilitation groups of three previous randomized controlled trials [7], [8], [9].

Patients

In the original studies, a total of 473 patients were randomized to one of two treatment arms (242 fusion surgery, 231 multidisciplinary cognitive-behavioral and exercise rehabilitation). The precise admission criteria are given in the original studies [7], [8]

Final patient groups

Figure 1 shows the flow of patients through the studies (with the two Norwegian studies being pooled). Of the 473 patients included in the combined studies at baseline (242 surgery, 231 multidisciplinary cognitive-behavioral and exercise rehabilitation), 261 (55%) completed the LTFU, 140 of whom had been randomized to fusion surgery and 121 to multidisciplinary cognitive-behavioral and exercise rehabilitation. There were 10 deaths in patients randomized to fusion, and just one death in those

Main findings

The aim of the present study was to compare the long-term (average 11 years) outcome of patients with cLBP randomized to surgical lumbar fusion or multidisciplinary cognitive-behavioral and exercise rehabilitation, from three randomized controlled trials conducted in the United Kingdom and Norway. No statistically significant or clinically relevant group differences in either the primary outcome (ODI) or any secondary outcomes were observed at LTFU, regardless of whether ITT or as-treated

Acknowledgments

We are grateful to AO Spine for their financial support of the study via the Hansjörg Wyss Research Award. In the United Kingdom, the study was also supported by Thames Valley Comprehensive Local Research Network for National Institute for Health Research. In Norway, the study was supported by grants from the Norwegian Research Council. From the United Kingdom, we thank Rory Popert, Marian Montgomery, David Gray, Jennifer Piper, Faye Highfield, Dr Mark Dolman, Hema Collappen, Jonathan Lau, and

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    FDA device/drug status: Not applicable.

    Author disclosures: AFM: Nothing to disclose. JIB: Grant: Norwegian Research Council for 2 doctoral students on related research (E, Paid directly to institution/employer); Speaking/Teaching Arrangements: AO (B, Paid directly to institution/employer); Scientific Advisory Board: Cochrane Advisory Board, Low Back Pain; Other Office: Cochrane Advisory Board, Low Back Pain. JCTF: Grant: University of Oxford (F); Grant: AO Spine (E).

    The disclosure key can be found on the Table of Contents and at www.TheSpineJournalOnline.com.

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