The effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: two years' follow-up of the randomized controlled trial.

Chronic reflex sympathetic dystrophy is a painful, disabling disorder for which no treatment with proven effect is available. We performed a randomized trial in a 2 to 1 ratio of patients, in which 36 patients were treated with spinal cord stimulation and physical therapy (SCS+PT), and 18 patients received solely PT. Twenty-four SCS+PT patients were given a permanent spinal cord stimulation system after successful test stimulation; the remaining 12 patients received no permanent system. We assessed pain intensity, global perceived effect, functional status, and health-related quality of life. Patients were examined before randomization, before implantation, and also at 1, 3, 6, 12, and 24 months thereafter. At 2 years, three patients were excluded from the analysis. The intention-to-treat analysis showed improvements in the SCS+PT group concerning pain intensity (-2.1 vs 0.0 cm; p < 0.001) and global perceived effect (43% vs 6% "much improved"; p = 0.001). There was no clinically important improvement of functional status. Health-related quality of life improved only in the group receiving spinal cord stimulation. After careful selection and successful test stimulation, spinal cord stimulation results in a long-term pain reduction and health-related quality of life improvement in chronic reflex sympathetic dystrophy.