IMPORTANCE: The use of spinal cord stimulation for chronic pain after lumbar spine surgery is increasing, yet rigorous evidence of its efficacy is lacking. OBJECTIVE: To 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 PARTICIPANTS: This 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. INTERVENTIONS: Patients 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 MEASURES: The 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. RESULTS: Among 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 RELEVANCE: Among 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 REGISTRATION: ClinicalTrials.gov Identifier: NCT03546738
An observational multicenter study.
Return to work (RTW) is increasingly used to assess the standard, benefit, and quality of health care.
The aim of this study was to evaluate sick leave patterns ...among patients undergoing surgery for cervical radiculopathy and identify predictors of successful RTW using two nationwide databases.
Data from the Norwegian Registry for Spine Surgery (NORspine) and the Norwegian Labour and Welfare Administration were linked on an individual level. We included patients between 18 and 60 years of age registered in NORspine from June 2012 through December 2019 that were temporarily out of the labor force for medical reasons at the time of surgery. We assessed types and grades of sickness benefits before and after surgery and conducted logistic regression analyses.
Among 3387 patients included in the study, 851 (25.1%) received temporary benefits one year before surgery. The proportion of recipients increased steadily towards surgery. Postoperatively the medical benefit payment decreased rapidly, and half of the patients had already returned to work by four months. The rate of RTW reached a plateau at one year. By the end of the third year, 2429 patients (71.7%) had returned to work. The number of sick days, categorized as 90 or less, during the year before surgery had the most powerful association with RTW at two years (odds ratio: 4.54, 95% CI: 3.42-6.03, P <0.001). Improvement in neck-related disability was the second strongest predictor (odds ratio: 2.17, 95% CI: 1.69-2.78, P <0.001).
RTW after cervical radiculopathy surgery occurs primarily during the first year. The strongest predictor of RTW was fewer sick days before surgery. The clinical improvement after surgery had a lesser impact.
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