A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions.

摘要: STUDY DESIGN A randomized double-blind prospective comparison with a placebo control. This report of the results is first in an ongoing study. OBJECTIVES To evaluate effect noninvasive capacitively coupled electrical stimulation on success rate lumbar spine fusion surgery, and to compare active stimulators as adjuncts contemporary techniques. SUMMARY OF BACKGROUND DATA Previous studies have established effectiveness direct current electromagnetic field for some forms spinal fusion. None previous placebo-controlled external bone included posterolateral techniques, most were conducted prior generations internal fixation hardware. METHODS The investigation was by 28 U.S. surgeons. Patients primary diagnosis degenerative disc disease or without other changes selected. study protocol defined clinical outcome rated excellent good documented solid both investigator blinded independent radiologist. Disagreements radiographic resolved second reviewer. RESULTS For 179 patients who completed treatment evaluation, overall (both successes) 84.7% 64.9% patients. difference highly significant according Yates corrected chi-square test (P = 0.0043). Best improvements patient outcomes (20% greater rate) occurred when used conjunction 0.006) also incorporated 0.013). DISCUSSION consistent that improved each stratification, although strata had insufficient numbers statistical significance. Improved rates added are hypothesized result from overcoming biochemical effects stress shielding. CONCLUSIONS Capacitively effective adjunct fusion, especially those fixation.