Comparison of spinal fusion and nonoperative treatment in patients with chronic low back pain: long-term follow-up of three randomized controlled trials
Two articles on PainSci cite Mannion 2013: 1. The Complete Guide to Low Back Pain 2. Long term results of spinal fusion: good news and bad?
PainSci notes on Mannion 2013:
This interesting paper is a detailed very long-term update — after an average of 11 years! — on the status of hundreds of patients who previously participated in three different trials of spinal fusion and cognitive behavioural therapy for back pain. The results were resoundingly negative: “there was no difference in patient self-rated outcomes between fusion and multidisciplinary cognitive-behavioral and exercise rehabilitation for cLBP.”
original abstract †Abstracts here may not perfectly match originals, for a variety of technical and practical reasons. Some abstacts are truncated for my purposes here, if they are particularly long-winded and unhelpful. I occasionally add clarifying notes. And I make some minor corrections.
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.
- “The long-term outcome of lumbar fusion in the Swedish lumbar spine study,” Hedlund et al, The Spine Journal, 2016.
- “Consensus at last! Long-term results of all randomized controlled trials show that fusion is no better than non-operative care in improving pain and disability in chronic low back pain,” Mannion et al, Spine J, 2016.
- Long term results of spinal fusion: good news and bad? — The results of the long-term Swedish lumbar spine study seemed mixed at first, but are probably just negative
This page is part of the PainScience BIBLIOGRAPHY, which contains plain language summaries of thousands of scientific papers & others sources. It’s like a highly specialized blog. A few highlights:
- Inciting events associated with lumbar disc herniation. Suri 2010 Spine J.
- Prediction of an extruded fragment in lumbar disc patients from clinical presentations. Pople 1994 Spine (Phila Pa 1976).
- Characteristics of patients with low back and leg pain seeking treatment in primary care: baseline results from the ATLAS cohort study. Konstantinou 2015 BMC Musculoskelet Disord.
- Effectiveness and cost-effectiveness of universal school-based mindfulness training compared with normal school provision in reducing risk of mental health problems and promoting well-being in adolescence: the MYRIAD cluster randomised controlled trial. Kuyken 2022 Evid Based Ment Health.
- No long-term effects after a three-week open-label placebo treatment for chronic low back pain: a three-year follow-up of a randomized controlled trial. Kleine-Borgmann 2022 Pain.