Clin Cases Miner Bone Metab. 2016 Sep-Dec;13(3):234-236.
Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized
Leali PT, Solla F, Maestretti G, Balsano M, Doria C
- 200 patients in each group (good study size)
- VAS pain scores dropped from 4.8 to 2.3/10 within 24 hours (p <0.023)
- 65%) treated with Vertebroplasty were able to stop any analgesia after 48 hours (p ≤ 0.0001)
- Control group – pain medication, osteoporosis medication, physiotherapy or bracing – very little change
- “Pain relief and improve mobility, functionality physics after VP
are quick and significantly better in the near compared to non-surgical treatment.”
MORON NEJM STUDY
don’t ask me why but NEJM has put through three MORON pain studies that have slowed progress in pain medicine – one on vertebroplasty, one on facet injection without any local added, and one involving arthroscopy knees.
NEJM Vertebroplasty study:
Kallmes, David F., et al. “A randomized trial of vertebroplasty for osteoporotic spinal fractures.” New England Journal of Medicine 361.6 (2009): 569-579.
- they took fracture cases up to 1 year old and relied on bone scan for evidence of active process present where arthritis in areas (and facet loading does occur) can give false positive results. It has been shown since that older fractures don’t do well. Reminds me of the Women’s Health Initiative where they made it clear early on they were out to show estrogens were bad for women. They took women up to 80 and got the results they wanted. When later re-analyzed it was clear estrogens were beneficial under age of 60- and actually showed regression of coronary calcifications. Most compression fracture activity is in first 4-8 weeks; not a year later. Pumping cement into a back where facet arthritis is the active issue is going to make things worse.
- They only injected 3 mls cement which is considered small in one arguing article:
An Objection to the New England Journal of Medicine Vertebroplasty Articles
Smith, Steven J, MD; Vlahos, Athanasios, MD; Sewall, Luke E, MD. Canadian Association of Radiologists Journal; Montreal61.2 (Apr 2010): 121-2.
they state that experienced operators reposition, wait and reinject – but no point of doing that if you are out to prove it did not work.
This reminds me of one steroid injection article where they injected trivial doses of steroid and as a result, concluded steroid injections don’t work
- the sham procedure was an injection of bupivacaine into the periosteum next to the facet joints. Well, facets may be where the pain is, in late compression fractures, and injecting can make a difference:
Pain Med. 2010 Nov;11(11):1674-7. doi: 10.1111/j.1526-4637.2010.00953.x.
Facet pain in thoracic compression fractures.
Mitra R(1), Do H, Alamin T, Cheng I.
- People with low pain to start with do not improve with any treatment – I’ve seen that frequently enough – they don’t give stats on pain so low pain subjects could have easily nullified results
- The authors of the NEJM article were caught out by the fact 4 times as many patients crossed over to get verteboplasty in their study
- The Canadian rebuttal makes it clear “These patients do extremely well as a group, leave their hospital beds, stop disorienting narcotics, and get their live back.” Shame on you NEJM.