Use of 10-kHz spinal cord stimulation (SCS) in patients with intractable chronic abdominal pain (CAP) can provide durable pain relief and improve quality of life, according to results of a prospective, single-arm, multi-center study published in Clinical and Translational Gastroenterology.
CAP is associated with impaired functioning and substantial emotional and mental burden. Currently, there are few treatment options with proven safety and efficacy for patients with CAP. Consequently, researchers investigated the safety and efficacy of 10-kHz SCS in patients with intractable CAP between June 2016 and November 2017.
In total, the researchers enrolled 24 patients with CAP who had been refractory to conventional medical treatment for at least 3 months and had self-reported pain scores ≥5 cm on a 10-cm visual analog scale. The average age of participants was 48.0±13.1 years (±SD). Participants had been diagnosed an average of 7.8±8.5 years (±SD) prior to the study period. Furthermore, 23 participants were white and 19 were female. The participants had stimulation leads positioned from vertebral levels T4-T8 and underwent trial stimulation lasting up to 14 days. Trials producing at least 70% pain relief were deemed successful.
The results showed that 23 out of the 24 participants experienced pain relief of at least 70% compared with the baseline VAS scores. These patients were subsequently implanted with a Senza system and followed up to 12 months after surgery. Treatment with 10-kHz SCS significantly reduced VAS pain scores by 6 cm from baseline on the visual analog scale up to 12 months after the initiation of treatment. Approximately 78% of participants were responders, showing pain relief ≥50%, and 63.6% of participants were remitters, showing sustained ≤3.0-cm visual analog scale scores. Pain scores also significantly decreased from baseline to 3- and 12-month follow-up visits, with the average total pain score decreasing from 4.0 (95% CI, 3.4-4.5) at baseline to 1.5 (95% CI, 0.9-2.2) at 12 months (P <.001). Furthermore, improvements in secondary outcomes including evaluations of mental and physical well-being, disability, perception of improvement, sleep quality, and satisfaction, showed that 10-kHz SCS greatly enhanced quality of life in patients with CAP. Participants also reported concurrent decrease or resolution of nausea and/or vomiting.
Limitations of the study included the lack of a control group and the use of randomization, which may have led to selection bias.
The researchers concluded that neuromodulation may be an effective treatment modality for chronic abdominal pain, and that further large randomized prospective trials are warranted.
Kapural L, Gupta M, Paicius R, Strodtbeck W, Vorenkamp KE, Gilmore C, et al. Treatment of chronic abdominal pain with 10-kHz spinal cord stimulation: Safety and efficacy results from a 12-month prospective, multicenter, feasibility study. Clin Transl Gastroenterol. 2020 Feb; 11(2): e00133