Laura Demartini1, Gaetano Terranova1,2, Massimo A Innamorato3, Alessandro Dario4, Michele Sofia5, Carlo Angelini5, Genni Duse6, Amedeo Costantini7, Matteo L G Leoni8. 1. Pain Unit, Clinical Scientific Institutes Maugeri, Pavia, Italy. 2. Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy. 3. Pain Unit, Santa Maria delle Croci Hospital, AUSL Romagna, Ravenna, Italy. 4. Neurostimulation Center, Department of Neurosurgery, Macchi Foundation Hospital, Varese, Italy. 5. ASST Rhodense, The Hospital of Garbagnate Milanese, Milanese, Italy. 6. Pain Managment Unit, S. Antonio Hospital, Padua, Italy. 7. Pain Clinic, Ospedale Clinicizzato SS. Annunziata, Chieti, Italy. 8. Interventional Pain Unit, G. da Saliceto Hospital, Piacenza, Italy.
Abstract
BACKGROUND: Spinal cord stimulation (SCS) is a well-known treatment in patients with failed back surgery syndrome (FBSS). Burst stimulation is a recently developed stimulation modality that seems to be superior to tonic stimulation. METHODS: This observational multicenter study compared tonic and burst stimulation during a trial period in patients with FBSS or radiculopathy. All the patients enrolled underwent two weeks of tonic stimulation followed by another two weeks of BurstDR stimulation, without randomization. The primary outcome was the reduction of pain in the legs and back. Health-related quality of life (EQ-5D) and the pain catastrophizing scale (PCS) were assessed before and after the trial. Patients were reevaluated after 12 months. RESULTS: We recruited 23 patients, 57% of whom had FBSS and 43% had radiculopathies. Five patients failed both the tonic and burst stimulation trials. While tonic stimulation reduced leg pain (p < 0.05), the burst mode added an extra pain reduction (ΔNRS 1.2 ± 1.5) (p < 0.01). No significant reduction in back pain was found (p 0.29). Pain on movement was reduced only by BurstDR (p < 0.01). Both stimulation modalities increased EQ-5D and reduced PCS from the baseline (p < 0.0001). At the end of the SCS trial phase, 26% patients chose tonic SCS, while 74% preferred burst. On 12-month follow-up examination, the benefits recorded at the end of the trial were maintained. CONCLUSIONS: Burst stimulation confers a greater reduction in leg pain intensity at rest and on movement. Reducing axial pain is still a challenge. Further studies are needed in order to provide each patient with the most appropriate stimulation paradigm.
BACKGROUND: Spinal cord stimulation (SCS) is a well-known treatment in patients with failed back surgery syndrome (FBSS). Burst stimulation is a recently developed stimulation modality that seems to be superior to tonic stimulation. METHODS: This observational multicenter study compared tonic and burst stimulation during a trial period in patients with FBSS or radiculopathy. All the patients enrolled underwent two weeks of tonic stimulation followed by another two weeks of BurstDR stimulation, without randomization. The primary outcome was the reduction of pain in the legs and back. Health-related quality of life (EQ-5D) and the pain catastrophizing scale (PCS) were assessed before and after the trial. Patients were reevaluated after 12 months. RESULTS: We recruited 23 patients, 57% of whom had FBSS and 43% had radiculopathies. Five patients failed both the tonic and burst stimulation trials. While tonic stimulation reduced leg pain (p < 0.05), the burst mode added an extra pain reduction (ΔNRS 1.2 ± 1.5) (p < 0.01). No significant reduction in back pain was found (p 0.29). Pain on movement was reduced only by BurstDR (p < 0.01). Both stimulation modalities increased EQ-5D and reduced PCS from the baseline (p < 0.0001). At the end of the SCS trial phase, 26% patients chose tonic SCS, while 74% preferred burst. On 12-month follow-up examination, the benefits recorded at the end of the trial were maintained. CONCLUSIONS: Burst stimulation confers a greater reduction in leg pain intensity at rest and on movement. Reducing axial pain is still a challenge. Further studies are needed in order to provide each patient with the most appropriate stimulation paradigm.
Authors: Martijn R Mons; Caro Edelbroek; Xander Zuidema; Katja Bürger; Lars Elzinga; Jessica de Vries; Sander van Kuijk; Elbert A Joosten; Jan-Willem Kallewaard Journal: Trials Date: 2022-09-05 Impact factor: 2.728