"These findings give us as good evidence as there is -- in a study without a group receiving another or no treatment for comparison -- that patients are more functional for up to a year after vertebroplasty than before vertebroplasty," says David Kallmes, M.D., the Mayo Clinic neuroradiologist who led the study.
The investigators conducted the study to assess vertebroplasty with a well-validated questionnaire specifically designed to measure back pain, the Roland-Morris Disability Questionnaire (RDQ). They reviewed records of 113 Mayo Clinic vertebroplasty patients. Of this group, RDQ scores were available for 108 patients before vertebroplasty treatment, and after treatment for 93 patients at one week, 73 patients at one month, 46 patients at six months and 15 patients at one year. Patients' pain during rest and activity improved an average of seven points one week after treatment and remained improved one year following vertebroplasty. Prior to treatment, the average RDQ score was 18 on a scale of 23. The RDQ dropped to an average score of 11 immediately after treatment and remained at that level throughout the study.
Dr. Kallmes explains that in light of the wide practice of vertebroplasty for vertebral compression fractures, a study using a top-caliber back pain measurement tool like the RDQ was critical, especially in light of the often subjective nature of pain reporting by different patients.
"It's hard to remember your pain," he says. "Also, it's hard to say how bad my pain is compared to your pain. I've had patients say their pain is no better after treatment, yet I look at them and they look 10 times better."
Dr. Kallmes explains that ultimately, vertebroplasty needs evaluation through a study of the highest quality, a clinical trial in which patients are randomly assigned to receive treatment or no treatment and in which the patients and investigators are blinded to which patients receive the real treatment or a placebo used for comparison.
"Vertebroplasty has been promulgated by physicians who performed the procedure without quantifying the benefit," he says. "Yet, medical literature is rife with studies that have debunked therapies that are already in use."
Dr. Kallmes is making strides toward high-quality measurement of vertebroplasty. Currently, he is leading an international, multicenter study looking at whether the cement used in vertebroplasty is responsible for the pain relief reported by patients. Patients in this study are randomly assigned to receive treatment with the real cement used in vertebroplasty or a placebo.
Patients for whom vertebroplasty is appropriate, according to Dr. Kallmes, have osteoporosis or a similar condition and have suffered compression of their spines with no or minimal injury. For example, while bending over to tie their shoes or turning over in bed, patients' vertebrae may fracture because their bones are weakened due to osteoporosis. Each year, 700,000 people suffer this injury. For four out of five patients, the fracture heals and the accompanying pain goes away in approximately four weeks with bed rest and analgesics. However, for one in five patients, the fracture does not heal and the pain persists, requiring treatment. Surgery is not an option for these patients, as their bones are too weak. Vertebroplasty is the only available treatment option for patients in this condition.
Vertebroplasty is not appropriate for patients with back pain due to ligament injuries, joint disease or narrowing of the spinal canal, says Dr. Kallmes.
For more on vertebroplasty, see http://www.