Vertebroplasty offers no pain-relief advantages over non-cement techniques for spinal compression fractures

Studies on the pain-relieving effect that vertebroplasty has as a treatment for osteoporotic vertebral compression fractures often compare its results with those of conservative care.

However, the first randomized controlled study to use a double-blinded method to compare vertebroplasty with a simulated vertebroplasty technique without cement injections found similar pain improvement results in both groups 1 month after their procedures.

Researchers also reported immediate improvement in disability in both groups at 1 postoperative month, according to a press release.

The investigation, which appeared in The New England Journal of Medicine, involved 131 patients, including 68 patients in the vertebroplasty group and 63 patients in the control group, who presented with one to three painful osteoporotic vertebral compression fractures.

An international, multicenter study

Investigators at eight centers in the United States, United Kingdom and Australia participated in study, which sought to better identify the role that cement injection plays in the vertebroplasty process concerning altering pain-related dysfunction.

“Though the medical community has been using vertebroplasty for many years, there were no research results to prove whether the efficacy of the treatment relates to the cement injections, patient expectations or other factors,” lead author David F. Kallmes, MD, of the Mayo Clinic, Rochester, Minn., said in the press release.

“The cement is a permanent medical implant, and there is some concern that it places patients at future risk for additional spinal fractures,” he added.

To rule out the effects of cement, investigators used a sham simulated vertebroplasty procedure not involving cement in the control group. Patients in both groups received the interventions to which they were originally assigned. After 1 month, they were allowed to cross over to the other group.

To assess primary outcomes of disability and pain, investigators used modified Roland-Morris Disability Questionnaire (RDQ) scores (0-to-23-point scale) and a patient-rated pain intensity score (0-to-10-point scale). Higher scores represent more significant symptoms on both scales.

No significant differences between groups

One month after surgery, the difference between both groups’ RDQ scores was 0.7 (CI 95%, -1.3 to 2.8; P=.49). The difference between their pain scores was 0.7 (CI 95%, -0.3 to 1.7; P=.19).

In their abstract, the investigators said the groups’ results did not differ significantly based on any secondary outcomes. One patient in each group experienced an adverse event.

The researchers plan to follow patients to 1-year postop, according to the press release.

“We aren’t saying the vertebroplasty doesn’t work, because somehow it does,” Kallmes said in the release. “But both sets of patients experienced significant improvements in pain and function a month following the procedure whether they received the cement injections or not. Improvements may be the result of local anesthesia, sedation, pain expectations or other factors.”

The study was funded by the National Institutes of Health.

Reference:
Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009; 361:569-579.