ImportanceThe use of spinal cord stimulation for chronic pain after lumbar spine surgery is increasing, yet rigorous evidence of its efficacy is lacking.ObjectiveTo investigate the efficacy of spinal cord burst stimulation, which involves the placement of an implantable pulse generator connected to electrodes with leads that travel into the epidural space posterior to the spinal cord dorsal columns, in patients with chronic radiculopathy after surgery for degenerative lumbar spine disorders.Design, Setting, and ParticipantsThis placebo-controlled, crossover, randomized clinical trial in 50 patients was conducted at St Olavs University Hospital in Norway, with study enrollment from September 5, 2018, through April 28, 2021. The date of final follow-up was May 20, 2022.InterventionsPatients underwent two 3-month periods with spinal cord burst stimulation and two 3-month periods with placebo stimulation in a randomized order. Burst stimulation consisted of closely spaced, high-frequency electrical stimuli delivered to the spinal cord. The stimulus consisted of a 40-Hz burst mode of constant-current stimuli with 4 spikes per burst and an amplitude corresponding to 50% to 70% of the paresthesia perception threshold.Main Outcomes and MeasuresThe primary outcome was difference in change from baseline in the self-reported Oswestry Disability Index (ODI; range, 0 points [no disability] to 100 points [maximum disability]; the minimal clinically important difference was 10 points) score between periods with burst stimulation and placebo stimulation. The secondary outcomes were leg and back pain, quality of life, physical activity levels, and adverse events.ResultsAmong 50 patients who were randomized (mean age, 52.2 [SD, 9.9] years; 27 [54%] were women), 47 (94%) had at least 1 follow-up ODI score and 42 (84%) completed all stimulation randomization periods and ODI measurements. The mean ODI score at baseline was 44.7 points and the mean changes in ODI score were −10.6 points for the burst stimulation periods and −9.3 points for the placebo stimulation periods, resulting in a mean between-group difference of −1.3 points (95% CI, −3.9 to 1.3 points; P = .32). None of the prespecified secondary outcomes showed a significant difference. Nine patients (18%) experienced adverse events, including 4 (8%) who required surgical revision of the implanted system.Conclusions and RelevanceAmong patients with chronic radicular pain after lumbar spine surgery, spinal cord burst stimulation, compared with placebo stimulation, after placement of a spinal cord stimulator resulted in no significant difference in the change from baseline in self-reported back pain–related disability.Trial RegistrationClinicalTrials.gov Identifier: NCT03546738
OBJECTIVE Surgery for chronic subdural hematoma (CSDH) is one of the most common neurosurgical procedures. The benefit of postoperative passive subdural drainage compared with no drains has been established, but other drainage techniques are common, and their effectiveness compared with passive subdural drains remains unknown. METHODS In Scandinavian population-based cohorts the authors conducted a consecutive, parallel cohort study to compare different drainage techniques. The techniques used were continuous irrigation and drainage (CID cohort, n = 166), passive subdural drainage (PD cohort, n = 330), and active subgaleal drainage (AD cohort, n = 764). The primary end point was recurrence in need of reoperation within 6 months of index surgery. Secondary end points were complications, perioperative mortality, and overall survival. The analyses were based on direct regional comparison (i.e., surgical strategy). RESULTS Recurrence in need of surgery was observed in 18 patients (10.8%) in the CID cohort, in 66 patients (20.0%) in the PD cohort, and in 85 patients (11.1%) in the AD cohort (p < 0.001). Complications were more common in the CID cohort (14.5%) compared with the PD (7.3%) and AD (8.1%) cohorts (p = 0.019). Perioperative mortality rates were similar between cohorts (p = 0.621). There were some differences in baseline and treatment characteristics possibly interfering with the above-mentioned results. However, after adjusting for differences in baseline and treatment characteristics in a regression model, the drainage techniques were still significantly associated with clinical outcome (p < 0.001 for recurrence, p = 0.017 for complications). CONCLUSIONS Compared with the AD cohort, more recurrences were observed in the PD cohort and more complications in the CID cohort, also after adjustment for differences at baseline. Although the authors cannot exclude unmeasured confounding factors when comparing centers, AD appears superior to the more common PD. Clinical trial registration no.: NCT01930617 (clinicaltrials.gov).
OBJECT By exploring longitudinal patient-reported health-related quality of life (HRQoL), the authors sought to assess the quality of survival for patients in the 1st year after diagnosis of glioblastoma. METHODS Thirty unselected patients ≥ 18 years who underwent primary surgery for glioblastoma in the period 2011–2013 were included. Using the generic HRQoL questionnaire EQ-5D 3L, baseline HRQoL was assessed before surgery and at postoperative follow-up after 1, 2, 4, 6, 8, 10, and 12 months. RESULTS There was an apparent correlation between deterioration in HRQoL scores and tumor progression. Patients with permanent deterioration in HRQoL early after surgery represented a subgroup with rapid progression and short survival. Both positive and negative changes in HRQoL were more often seen after surgery than after radio- or chemotherapy. Patients with gross-total resection (GTR) reported better and more stable HRQoL. In a multivariable analysis preoperative cognitive symptoms (p = 0.02), preoperative functional status (p = 0.03), and GTR (p = 0.01) were independent predictors of quality of survival (area under the curve for EQ-5D 3L index values). CONCLUSIONS The results indicate that progression-free survival is not only a surrogate marker for survival, but also for quality of survival. Quality of survival seems to be associated with GTR, which adds further support for opting for extensive resections in glioblastoma patients with good preoperative functional levels.
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