The study, coming out of Australia, "Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicenter, randomised, blinded, placebo-controlled trial," considered 120 patients. Sixty-one patients were randomly assigned to vertebroplasty and 59 to a placebo procedure. Only patients with severe pain of 7 or higher on a numeric rating scale (NRS) of 10 were enrolled.
‘For the first time, vertebroplasty has been demonstrated to reduce pain more effectively than a sham intervention. Conservative therapy including narcotics, bedrest and back braces, are themselves not risk-free.’
After 14 days of treatment, 23 percent of patients in the vertebroplasty group reported an NRS pain of lower than 4. While 53 percent of patients in the placebo group still had moderate or severe pain six months after the procedure, patients in the vertebroplasty group reported lower pain at all time intervals after the procedure. Almost 1.4 million patients in the world suffer fractures caused by osteoporosis. While many experience mild symptoms, a portion of them develop considerable pain and disability and require hospital admission.
Vertebroplasty could help them manage their pain and lead to reduced hospital stays, which would lead to overall health care savings. In addition, the study also found the procedure does not contribute to future fractures as was, at times, previously thought.
"These findings are important because, for the first time, vertebroplasty has been demonstrated to reduce pain more effectively than a sham intervention," says Dr. Joshua Hirsch, Past President of the Society of NeuroInterventional Surgery and author of the companion expert commentary in
The Lancet. "Moreover, the trial suggests that conservative therapy including narcotics, bedrest and back braces, are themselves not risk-free. Indeed, in prior open label trials such as VERTOS 2, vertebroplasty has performed dramatically better than conservative therapy.
Source: Eurekalert
