Vertebroplasty and Balloon Kyphoplasty: Options for the Management of Pain due to Collapsed Vertebrae
Summary written by Michele Bellantoni, M.D.
Diamond et al (Am J Med 114(4):326-8, 2003) approached all patients at St. Georges Hospital in Sydney Austrialia who had experienced a recent collapse of a spine vertebrae over 13 months beginning November 2001. They offered vertebroplasty to all patients whose pain was not adequately controlled by non-narcotic pain medicines. The procedures were performed under local anesthesia with a needle placed through the skin of the back and into the collapsed bone. A liquid cement, polymethylmethacrylate was injected under x-ray guidance.
Results: They recruited a sufficient number of subjects, 55, for vertebroplasty, while the comparison group was 24 patients who declined the procedure. They found a clinically as well as statistically significant decrease in pain and improvement in physical function 24 hours after vertebroplasty, with no change as expected in the control group. However, there was no difference between patients who underwent the procedure compared with those who did not in either pain or physical function at 6 weeks and 6 to 12 months.
Conclusion: This suggests that the procedure is best used in the management of new vertebral fractures when pain is not controlled with medications and physical treatments such as warm moist heat and massage. There are many patients whom I find I cannot adequately control pain without significant side effects of medications such as constipation and over-sedation from narcotics, or stomach upset with non-steroidal anti-inflammatory medicines.
Ledlie et al (J Neurosurg 2003 98:36-42, 2003) look back on the outcomes of the first 96 patients in whom they performed balloon kyphoplasty. They, like Diamond and colleagues, offered their procedure to patients whose pain after recent vertebral fractures was not controlled with standard medical management. They used general anesthesia. The balloon procedure differed from the vertebroplasty procedure mentioned above in that the balloon is inflated inside the collapsed vertebrae in an effort to return the fractured bone to its pre-fracture height, and then the cavity created by the re-inflated bone is filled with a liquid cement.
Results: Like the Diamond study, the reseasrchers recorded a significant decrease in pain scores and improved ambulation shortly after the procedures, this time measured at one week rather than one day. The pain relief and ambulatory status continued at 1 month, 3 month, 6 month and one year post-procedure assessments. Unlike the Diamond study, there was no control group that declined the procedure.
Conclusion: he authors demonstrated a significant improvement in the architecture of the collapsed spine bones following kyphoplasty with the average height of the front of the collapsed bones increasing from 66% of normal height to 89%.
Editorial Comment: Both of these studies demonstrate that the two procedures, vertrebroplsty and balloon kyphoplasty improve uncontrolled pain from vertebral collapse due to osteoporosis. However, neither study addresses the issue that a person willing to undergo an invasive procedure has a powerful motivation to feel better after the proceudure, the so-called placebo effect. This is possible, as a recent study of patients with knee pain found such an effect. When patients were randomly assigned to arthroscopic knee surgery or staged surgery that did not include the actual manipulations inside the knee, pain was improved in both groups to a similar degree.
To date, there are no studies of vertebroplasty or kyphoplasty that randomly assign patients to the procedure or a “staged-procedure”, so that the patient is not aware of the actual treatment received. This type of study has not been done as it is difficult to recruit patients who are not able to choose their own treatment. Also, the physicians who perform the procedures are reluctant to commit the resources needed to perform “staged” procedures. There is a small, but real risk of anesthesia, bleeding or infection associated with placing a needle through the skin, but not injecting the cement or performing the balloon re-inflation followed by cementing of the collapsed bone.
Kyphoplasty using the balloon re-inflation permits a return to a more normal spinal alignment than vertebroplasty. Does this make a difference in long-term back pain syndromes or lung function that can be compromised with severe kyphosis? No studies have addressed this issue.
In summary, both vertebroplasty and kyphoplasty are options available in most medical centers to manage uncontrollable pain of acute vertebral spine fractures. More studies are needed to determine how best to incorporate these options into medical care of osteoporosis patients.