A sham‐controlled, randomized trial of spinal cord stimulation for the treatment of pain in chronic pancreatitis

Abstract Background Spinal cord stimulation (SCS) has emerged as a treatment option for patients with chronic pancreatitis (CP) who experience pain that does not respond to standard interventions. However, there is a lack of sham‐controlled trials to support its efficacy. Methods This randomized, double‐blinded, sham‐controlled, cross‐over trial enrolled 16 CP patients with insufficient pain relief from standard therapies. Patients underwent high‐frequency (1000 Hz) paraesthesia‐free SCS or sham for two 10‐day stimulation periods, separated by a 3‐day washout period. The primary outcome was daily pain intensity registered in a pain diary based on a numeric rating scale (NRS). Secondary outcomes included various questionnaires. Quantitative sensory testing was used to probe the pain system before and after interventions. Results The average daily pain score on the NRS at baseline was 5.2 ± 1.9. After SCS, the pain score was 4.2 ± 2.1 compared to 4.3 ± 2.1 in the sham group (mean difference −0.1, 95% CI [−1.4 to 1.1]; P = 0.81). Similarly, no differences were observed between groups for the maximal daily pain score, secondary outcomes or quantitative sensory testing parameters. During an open‐label, non‐sham‐controlled and non‐blinded extension of the study, the average daily NRS was 5.2 ± 1.7 at baseline, 3.2 ± 1.8 at 3 months, 2.9 ± 1.9 at 6 months and 3.4 ± 2.2 at 12 months of follow‐up ( P = 0.001). Conclusion In this first sham‐controlled trial of SCS in painful CP, we did not find evidence of short‐term pain relief with paraesthesia‐free high‐frequency (1000 Hz) stimulation. However, evaluation of the long‐term effect by larger sham‐controlled trials with long‐term follow‐up is warranted. Significance Statement In this first sham‐controlled trial to apply high‐frequency (1000 Hz) spinal cord stimulation in patients with visceral pain due to chronic pancreatitis, we did not find evidence for clinically relevant pain relief. Taken together with potential procedure‐related complications, adverse effects and costs associated with spinal cord stimulation, our findings question its use for management of visceral pain.