Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy

Background Chronic reflex sympathetic dystrophy (also called the complex re gional pain syndrome) is a painful, disabling disorder for which there is n o proven treatment. In observational studies, spinal cord stimulation has r educed the pain associated with the disorder. Methods We performed a randomized trial involving patients who had had refl ex sympathetic dystrophy for at least six months. Thirty-six patients were assigned to receive treatment with spinal cord stimulation plus physical th erapy, and 18 were assigned to receive physical therapy alone. The spinal c ord 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 pa in] 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-re lated quality of life. Results The test stimulation of the spinal cord was successful in 24 patien ts; the other 12 patients did not receive implanted stimulators. In an inte ntion-to-treat analysis, the group assigned to receive spinal cord stimulat ion plus physical therapy had a mean reduction of 2.4 cm in the intensity o f pain at six months, as compared with an increase of 0.2 cm in the group a ssigned to receive physical therapy alone (P<0.001 for the comparison betwe en 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 function al status. The health-related quality of life improved only in the 24 patie nts who actually underwent implantation of a spinal cord stimulator. Six of the 24 patients had complications that required additional procedures, inc luding removal of the device in 1 patient. Conclusions In carefully selected patients with chronic reflex sympathetic dystrophy, electrical stimulation of the spinal cord can reduce pain and im prove health-related quality of life. (N Engl J Med 2000; 343:618-24.) (C) 2000, Massachusetts Medical Society.