Failed trial of vertebroplasty for compression fractures
Two articles on PainSci cite Buchbinder 2009: 1. Complete Guide to Low Back Pain 2. Your Back Is Not Out of Alignment
PainSci commentary on Buchbinder 2009: ?This page is one of thousands in the PainScience.com bibliography. It is not a general article: it is focused on a single scientific paper, and it may provide only just enough context for the summary to make sense. Links to other papers and more general information are provided wherever possible.
This is one of a pair of 2009 papers (see also Kallmes et al) presenting strong evidence that there is “no beneficial effect” to stabilizing fractured spines with injections of bone cement (vertebroplasty), a common and yet apparently dubious procedure. That evidence is backed up by major reviews published since (Buchbinder 2015, Stevenson 2014), but some contrary evidence has also been published (Shi 2012, Klazen), and it is possible vertebroplasty works better for some kinds of patients.
The frequency of this “surgery” — though it is usually performed by surgeons, it’s just an injection in a tricky spot — will probably now drop off significantly, as surgeons demonstrate that they respect the evidence (when good science casts serious doubts on the efficacy of an intervention, most doctors will stop doing it within a few years).
The evidence is also a poetic addition to the evidence that spinal fragility is not a major driver of back pain. If stabilizing the spine with cement doesn’t resolve symptoms, it strongly suggests that instability wasn’t the problem to begin with.
Strictly speaking, the only thing this evidence can tell us is that patients with osteoporotic fractures who got vertebroplasty recovered no better than those who only thought they got vertebroplasty. But we can definitely infer more from it, because the rationale for vertebroplasty has always been cave-man simple: Ooog. Verteba [sic] busted. Hurt. Thag make bone stronger. Inject glue. Ugh. Supposedly these fractures are painful because the spine is unstable — hardly an unreasonable assumption — and therefore stabilizing them will help. Except it didn’t! Not in these patients. So it’s probably not the instability that’s causing all the pain.
See also Dr. David Gorski’s analysis for ScienceBasedMedicine.org.
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: Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures, but there is limited evidence to support its use.
METHODS: We performed a multicenter, randomized, double-blind, placebo-controlled trial in which participants with one or two painful osteoporotic vertebral fractures that were of less than 12 months' duration and unhealed, as confirmed by magnetic resonance imaging, were randomly assigned to undergo vertebroplasty or a sham procedure. Participants were stratified according to treatment center, sex, and duration of symptoms (<6 weeks or >=6 weeks). Outcomes were assessed at 1 week and at 1, 3, and 6 months. The primary outcome was overall pain (on a scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months.
RESULTS: A total of 78 participants were enrolled, and 71 (35 of 38 in the vertebroplasty group and 36 of 40 in the placebo group) completed the 6-month follow-up (91%). Vertebroplasty did not result in a significant advantage in any measured outcome at any time point. There were significant reductions in overall pain in both study groups at each follow-up assessment. At 3 months, the mean (+/-SD) reductions in the score for pain in the vertebroplasty and control groups were 2.6+/-2.9 and 1.9+/-3.3, respectively (adjusted between-group difference, 0.6; 95% confidence interval, -0.7 to 1.8). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven incident vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6-month follow-up period.
CONCLUSIONS: We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment.
related content
- “A randomized trial of vertebroplasty for osteoporotic spinal fractures,” David F Kallmes, Bryan A Comstock, Patrick J Heagerty, Judith A Turner, David J Wilson, Terry H Diamond, Richard Edwards, Leigh A Gray, Lydia Stout, Sara Owen, William Hollingworth, Basavaraj Ghdoke, Deborah J Annesley-Williams, Stuart H Ralston, and Jeffrey G Jarvik, New England Journal of Medicine, 2009.
- “Percutaneous vertebroplasty for osteoporotic vertebral compression fracture,” Rachelle Buchbinder, Kamran Golmohammadi, Renea V Johnston, Richard J Owen, Joanne Homik, Allyson Jones, Sukhvinder S Dhillon, David F Kallmes, and Robert G W Lambert, Cochrane Database of Systematic Reviews, 2015.
- “A randomized trial of vertebroplasty for osteoporotic spinal fractures,” David F Kallmes, Bryan A Comstock, Patrick J Heagerty, Judith A Turner, David J Wilson, Terry H Diamond, Richard Edwards, Leigh A Gray, Lydia Stout, Sara Owen, William Hollingworth, Basavaraj Ghdoke, Deborah J Annesley-Williams, Stuart H Ralston, and Jeffrey G Jarvik, New England Journal of Medicine, 2009.
- “Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial,” Caroline A H Klazen, Paul N M Lohle, Jolanda de Vries, Frits H Jansen, Alexander V Tielbeek, Marion C Blonk, Alexander Venmans, Willem Jan J van Rooij, Marinus C Schoemaker, Job R Juttmann, Tjoen H Lo, Harald J J Verhaar, Yolanda van der Graaf, Kaspar J van Everdingen, Alex F Muller, Otto E H Elgersma, Dirk R Halkema, Hendrik Fransen, Xavier Janssens, Erik Buskens, and Willem P Th M Mali, Lancet, 2010.
- “Is there really no benefit of vertebroplasty for osteoporotic vertebral fractures? A meta-analysis,” Ming-Min Shi, Xun-Zi Cai, Tiao Lin, Wei Wang, and Shi-Gui Yan, Clinical Orthopaedics & Related Research, 2012.
- “Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for the treatment of osteoporotic vertebral fractures: a systematic review and cost-effectiveness analysis,” Matt Stevenson, Tim Gomersall, Myfanwy Lloyd Jones, Andrew Rawdin, Monica Hernández, Sofia Dias, David Wilson, and Angie Rees, Health Technol Assess, 2014.
Specifically regarding Buchbinder 2009:
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:
- Photobiomodulation therapy is not better than placebo in patients with chronic nonspecific low back pain: a randomised placebo-controlled trial. Guimarães 2021 Pain.
- No effect of creatine monohydrate supplementation on inflammatory and cartilage degradation biomarkers in individuals with knee osteoarthritis. Cornish 2018 Nutr Res.
- The CANBACK trial: a randomised, controlled clinical trial of oral cannabidiol for people presenting to the emergency department with acute low back pain. Bebee 2021 Med J Aust.
- Relationships Between Sleep Quality and Pain-Related Factors for People with Chronic Low Back Pain: Tests of Reciprocal and Time of Day Effects. Gerhart 2017 Ann Behav Med.
- Modulation in the elastic properties of gastrocnemius muscle heads in individuals with plantar fasciitis and its relationship with pain. Zhou 2020 Sci Rep.