![]() ![]() Of the 22 SCS patients, 12 (55%) scored ≥6 (much improved) on the PGIC for pain ( P < 0.001) and 8 (36%) scored ≥6 on the PGIC scale for sleep ( P < 0.011). Eight patients (36%) showed ≥50% pain relief during nighttime in the SCS group, as compared with one patient (7%) in the BMT group ( P < 0.01). Mean pain at night was reduced by 2.4 points in the SCS group compared with 0.9 points on the NRS in the BMT group ( P < 0.003) ( Fig. In total, nine patients (41%) reported ≥50% pain relief during daytime in the SCS group, as compared with 0% in the BMT group ( P < 0.001). The mean pain score on the NRS during daytime in the SCS group was reduced by 3.1 points at 6 months as compared with no change in pain score in the BMT group ( P < 0.001) ( Fig. Treatment success of SCS was observed in 13 out of 22 patients (59%) and in 1 out of 14 BMT patients (7%) ( P < 0.009) ( Table 2). ![]() Patients were discharged from the hospital if no change in position of the lead was seen after X-ray verification. After implantation, patients were admitted to the hospital for 24 h. Thereafter, the lead was anchored to the paraspinal fascia of the interspinous ligament and an extension lead was threaded through the skin, fixed, and connected to an external stimulator (External Neurostimulator Trialing System Medtronic). The position of the lead over the thoracic level and settings of the external stimulator were tailored for each patient in order to reach optimal paraesthesia coverage. Subsequently, the lead was advanced through the needle and connected to an external programmable stimulator (N’Vision Medtronic). The patient was placed in prone position, and by using fluoroscopy, the epidural space was entered with a Tuohy needle at the lumbar level. Implantation of the SCS octapolar lead (Octad lead Medtronic, Minneapolis, MN) was performed using local anesthesia and antibiotic prophylaxis. PatientsĮxclusion criteria were as follows: neuropathic pain most prevalent in the upper limbs (NRS >3) neuropathy or chronic pain of other origin than DM recent neuromodulation therapy (5 units/day) abuse insufficient cooperation from the patient (little motivation, understanding, or communication) blood clotting disorder immune deficiency peripheral vascular disease with no palpable foot pulses at both feet (inclusion was possible if pulses were absent, but Doppler ankle-brachial index was between 0.7 and 1.2 in both feet) active foot ulceration life expectancy NYHA classification II) unstable blood glucose control (change in hemoglobin A 1c >1.0% in the 3 months preceding the trial) and use of oral anticoagulation that could not be stopped for a period of 10 days around the implantation procedure. An independent data and safety monitoring board reviewed the study procedures and outcomes. ![]() The study was approved by the medical ethics committee of the MUMC + and the institutional review board of the Radboud UMC. The study was performed at the outpatient pain clinics of the Maastricht University Medical Centre (MUMC +) and Radboud University Medical Center (Radboud UMC). A steering committee was responsible for the design of the study and for developing the protocol (available at, NCT01162993). Invasive therapy, such as intrathecal drug delivery, was not allowed. Prior to inclusion, all patients were treated with BMT according to the international guidelines ( 5, 7, 15) and the treatment algorithm of Jensen et al. This study was designed as a prospective multicenter RCT to assess the effectiveness of SCS in combination with BMT (SCS group) compared with BMT only (BMT group) in patients with PDPN in the lower limbs on pain, HRQoL, and functional ability. ![]()
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