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Vertebroplasty = sham procedure for compression fractures
Clinical Question
Is vertebroplasty more effective than sham surgery for osteoporotic vertebral fracture?
Bottom line
Given the lack of difference in pain relief following vertebroplasty or sham treatment of patients with compression fracture found in this study, it is tempting to say that this treatment approach is not effective. However, patients in both groups—cement injection or sham—received significant pain relief within a day of the procedure. (Maybe it's the acetic smell of the cement that does it?) Pain scores over time continued to improve in both groups, from an average 7.7 of 10 before treatment to less than 3 at 12 months, which likely represents the natural history of vertebral fractures. So, although the vertebroplasty was not superior to sham treatment, both provided significant relief. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry
Setting: Outpatient (specialty)
Synopsis
This study enrolled patients who were willing to undergo either vertebroplasty or sham surgery for the treatment of painful acute vertebral compression fracture ("acute" was initially defined as pain lasting less than 6 weeks but after having trouble recruiting enough patients the authors modified the definition to less than 9 weeks); these 180 patients represent approximately 54% of the patients they approached. After local anesthesia was applied to the appropriate pedicles, patients were randomized, using concealed allocation, to cement or sham therapy. To obscure the treatment assignment for patients, patients in the sham group had biopsy needles inserted and the team mixed up the cement in the room (but didn't inject it). The nurses who provided after-procedure care and the outcome assessors were masked to treatment assignment. Pain scores were significantly better following both vertebroplasty and sham treatment at 1 day, 1 week, 1 month, and 3, 6, and 12 months after the procedure, with no difference in pain score change or analgesic use between the groups. On a pain scale of 0 to 10, the average patient in both groups had a 4.75 to 5.0 drop in pain score (from an initial 7.7) by 12 months.
Reviewer
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, MA
Comments
? Placebo effect
It is interesting that both groups who received local anaesthetic, and needling of the spine had significant symptomatic improvement. It would have been interesting to have a comparison with a "usual care group". Perhaps the local anaesthetic and needling itself provides some therapeutic benefit.
As above
This study and the recent ORBITA trial are really making me think NOT doing sham procedure trials may be unethical...
That’s interesting. I note this study was industry funded...wonder what they will propose in response?
These results either demonstrate one hell of a placebo effect, or there was some other factor at work...? The local anesthetic injection ? The post procedure instructions? Change in post procedure (including post-sham procedure) activity? The terror of having big needles stuck in their spine? Also, not clear on what would have happened with those who had no procedure at all at the earlier measurement times, as opposed to at the one year mark...