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Multicenter Study Clinical Trial
A prospective, open-label, multicenter study to assess the efficacy of spinal cord stimulation and identify patients who would benefit.
- Kazuhide Moriyama, Kazushige Murakawa, Takeshi Uno, Kiyoshige Oseto, Minoru Kawanishi, Yoichi Saito, Takaomi Taira, and Masanori Yamauchi.
- Department of Pain Medicine, Hyogo College of Medicine, Hyogo, Japan. pain-med@hyo-med.ac.jp
- Neuromodulation. 2012 Jan 1;15(1):7-11; discussion 12.
Objective To identify patients likely to benefit from spinal cord stimulation (SCS).Materials And Methods This multicenter, prospective, open-label study included medical centers experienced in SCS therapy, carried out in 13 physicians in seven centers. We recruited 55 patients with complex regional pain syndrome, failed back surgery syndrome, or peripheral vascular disease. Neurostimulators were implanted in 34 patients found to respond to SCS in a preliminary test, who were then followed for six months. Thirty-four patients scored their pain on a visual analog scale (VAS) and completed the EuroQol-5D questionnaire before and after test stimulation and after one and six months.Results During test stimulation, the mean VAS and quality of life (QOL) scores improved from 74.0 to 23.4 and from 0.430 to 0.664, respectively, in the 34 patients. At six months, the mean VAS score was 29.7 in 29 patients and the mean QOL score was 0.661 in 31 patients.Conclusion SCS may improve pain management and QOL.© 2011 International Neuromodulation Society.
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