Timothy S. Carey, MD, MPH
In patients with painful osteoporotic vertebral fractures, does vertebroplasty alleviate pain and improve physical functioning?
Randomized placebo-controlled trial. ACTRN012605000079640.
Blinded (patients, investigators, and outcome assessors).*
4 hospitals in the Melbourne area, Victoria, Australia.
78 patients (mean age 77 y, 79% women) with back pain of ≤ 12 months’ duration (median 9 wk) and 1 (82% of patients) or 2 recent vertebral fractures (vertebral collapse ≥ grade 1 and edema and/or a fracture line in the vertebral body on magnetic resonance imaging). Exclusion criteria included previous vertebroplasty; vertebral collapse > 90%; fracture through, or destruction of, the posterior wall; bone fragments impinging on the spinal cord; spinal cancer; and neurologic complications.
Percutaneous vertebroplasty involving injection of about 3 mL of polymethylmethacrylate (PMMA) into the vertebral body (n = 38) or a sham procedure without injection of PMMA (n = 40).
Overall pain in the previous week, pain at rest, pain at night, disability, and quality of life. The trial had 99% power to detect a 1.5-point reduction in pain score (α = 0.05).†
91% (intention-to-treat analysis).
Groups did not differ for overall pain, disability (Table), pain at rest, pain at night, or quality of life.
In patients with painful osteoporotic vertebral fractures, vertebroplasty did not alleviate pain or improve physical functioning or quality of life more than a sham procedure.
Vertebroplasty vs sham procedure for painful osteoporotic fractures‡
‡Pain was measured on a scale of 1 to 10 (worst), with 1.5 considered as the minimal clinically important difference; mean baseline pain score was 7.4 in the vertebroplasty group and 7.1 in the sham group. Disability was measured by the modified Roland-Morris Disability Questionnaire on a scale of 0 to 23 (worst), with 2 to 3 points considered as the minimum clinically important difference; mean baseline disability score was 17.3 in both groups. Data provided by author.
§CI defined in Glossary. Adjusted for center, sex, duration of symptoms, and baseline score.
Carey TS. Vertebroplasty was not effective for painful osteoporotic vertebral fractures. Ann Intern Med. ;151:JC6–8. doi: 10.7326/0003-4819-151-12-200912150-02008
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Published: Ann Intern Med. 2009;151(12):JC6-8.
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