Efficacy and safety of ultrasound-guided pulsed radiofrequency therapy of stellate ganglion on refractory painful diabetic peripheral neuropathy

Abstract

Background: The best tool for management of pain associated with distal symmetric peripheral neuropathy(DSPN) is a matter of debate. The use of ultrasound-guided pulsed radiofrequency (PRF) therapy of stellate ganglion (SG) in patients with painful DSPN may decrease pain severity and the need for analgesics. Methods: Patients: We enrolled 56 patients with T2DM and refractory painful DSPN in this study. Intervention: The patients received bilateral ultrasound-guided SG pulsed radiofrequency therapies once on both sides. Measurement: The patients completed the visual analog scale (VAS), simplified McGill pain questionnaire (SF-MPQ), pain index, Toronto clinical score system (TCSS), sleep duration at night (SDN), pain disability index (PDI), Karnofsky performance status (KPS), depression screening scale (PHQ-9), and anxiety screening scale (GAD-7) to assess severity and quality of pain. After completing the procedures,the patient’s subjective sensations, including the degree of perceived pain relief, level of perceived numbness relief, extent of perceived chills relief, and side effects were assessed. All patients underwent baseline evaluation after the last procedure at 1-week, 4-week, 12-week, and 24-week follow-up periods. Results: The postoperative VAS were significantly lower than the preoperative VAS scores (P<0.001). The SF-MPQ score at 1, 4, 12, and 24 weeks postoperatively were significantly lower than the preoperative SF-MPQ score (P<0.001). The KPS after the procedures was significantly higher than the preoperative KPS (P<0.001); the postoperative PDI was significantly lower than the preoperative PDI (P<0.001). The postoperative SDN (P=0.005) was longer than the preoperative SDN. The postoperative PHQ-9 score was lower than the preoperative score PHQ-9 (P<0.05). The degree of perceived pain relief, chills relief, and numbness relief at 4, 12, and 24 weeks after the procedure were lower than that at 1 week after the procedures (P<0.001). The postoperative rates of administration of oral anticonvulsants and non-steroidal anti-inflammatory drugs were lower than those of preoperative period (P<0.001). The significant effective rates at 4, 12, and 24 weeks after procedure, were 67.86%, 42.86%, 21.43%, and 17.86%, respectively and the total effective rates were 89.29%,71.43%, 46.43%, and 32.14%, respectively, with a decreasing trend at all follow-up periods. No serious complication was observed. Conclusion: Ultrasound-guided stellate ganglion PRF therapy can effectively relieve pain and improve the quality of life in patients with refractory painful DSPN. International Review Board Number: ChiCTR2000035544 Clinical Trial registration Number: SHSY-IEC-4.1/21-48/01