Kemler M A, Barendse G A, van Kleef M, de Vet H C, Rijks C P, Furnée C A, van den Wildenberg F A
Department of Surgery, Maastricht University Hospital, The Netherlands.
N Engl J Med. 2000 Aug 31;343(9):618-24. doi: 10.1056/NEJM200008313430904.
Chronic reflex sympathetic dystrophy (also called the complex regional pain syndrome) is a painful, disabling disorder for which there is no proven treatment. In observational studies, spinal cord stimulation has reduced the pain associated with the disorder.
We performed a randomized trial involving patients who had had reflex sympathetic dystrophy for at least six months. Thirty-six patients were assigned to receive treatment with spinal cord stimulation plus physical therapy, and 18 were assigned to receive physical therapy alone. The spinal cord stimulator was implanted only if a test stimulation was successful. We assessed the intensity of pain (on a visual-analogue scale from 0 cm [no pain] to 10 cm [very severe pain]), the global perceived effect (on a scale from 1 [worst ever] to 7 [best ever]), functional status, and the health-related quality of life.
The test stimulation of the spinal cord was successful in 24 patients; the other 12 patients did not receive implanted stimulators. In an intention-to-treat analysis, the group assigned to receive spinal cord stimulation plus physical therapy had a mean reduction of 2.4 cm in the intensity of pain at six months, as compared with an increase of 0.2 cm in the group assigned to receive physical therapy alone (P<0.001 for the comparison between the two groups). In addition, the proportion of patients with a score of 6 ("much improved") for the global perceived effect was much higher in the spinal cord stimulation group than in the control group (39 percent vs. 6 percent, P=0.01). There was no clinically important improvement in functional status. The health-related quality of life improved only in the 24 patients who actually underwent implantation of a spinal cord stimulator. Six of the 24 patients had complications that required additional procedures, including removal of the device in 1 patient.
In carefully selected patients with chronic reflex sympathetic dystrophy, electrical stimulation of the spinal cord can reduce pain and improve the health-related quality of life.
慢性反射性交感神经营养不良（也称为复杂性区域疼痛综合征）是一种疼痛性、致残性疾病，尚无经证实的治疗方法。在观察性研究中，脊髓刺激已减轻了与该疾病相关的疼痛。
我们进行了一项随机试验，纳入患有反射性交感神经营养不良至少六个月的患者。36例患者被分配接受脊髓刺激加物理治疗，18例患者被分配仅接受物理治疗。仅在测试刺激成功时才植入脊髓刺激器。我们评估了疼痛强度（采用0厘米[无疼痛]至10厘米[非常严重疼痛]的视觉模拟量表）、整体感知效果（采用1[有史以来最差]至7[有史以来最好]的量表）、功能状态以及与健康相关的生活质量。
24例患者的脊髓测试刺激成功；其他12例患者未接受植入刺激器。在意向性分析中，分配接受脊髓刺激加物理治疗的组在六个月时疼痛强度平均降低了2.4厘米，而分配仅接受物理治疗的组疼痛强度增加了0.2厘米（两组之间比较，P<0.001）。此外，脊髓刺激组中整体感知效果评分为6分（“改善很多”）的患者比例远高于对照组（39%对6%，P = 0.01）。功能状态无临床上重要的改善。仅在实际接受脊髓刺激器植入的24例患者中，与健康相关的生活质量有所改善。24例患者中有6例出现需要额外手术的并发症，其中1例患者需要取出装置。
在精心挑选的慢性反射性交感神经营养不良患者中，脊髓电刺激可减轻疼痛并改善与健康相关的生活质量。
