| 1. |
- Hara, Sozaburo, et al.
(författare)
-
Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery: A Randomized Clinical Trial.
- 2022
-
Ingår i: JAMA. - 1538-3598. ; 328:15, s. 1506-1514
-
Tidskriftsartikel (refereegranskat)abstract
- The use of spinal cord stimulation for chronic pain after lumbar spine surgery is increasing, yet rigorous evidence of its efficacy is lacking.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.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.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.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.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.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.ClinicalTrials.gov Identifier: NCT03546738.
|
|
| 2. |
- Andersen, Mikkel Österheden, et al.
(författare)
-
Surgical Treatment of Degenerative Disk Disease in Three Scandinavian Countries : An International Register Study Based on Three Merged National Spine Registers
- 2019
-
Ingår i: Global Spine Journal. - : SAGE PUBLICATIONS LTD. - 2192-5682 .- 2192-5690. ; 9:8, s. 850-858
-
Tidskriftsartikel (refereegranskat)abstract
- Study Design: Observational study of prospectively collected data.Objectives: Patients with chronic low back pain resistant to nonoperative treatment often face a poor prognosis for recovery. The aim of the current study was to compare the variation and outcome of surgical treatment of degenerative disc disease in the Scandinavian countries based on The International Consortium for Health Outcomes Measurement core spine data sets.Methods: Anonymized individual level data from 3 national registers were pooled into 1 database. At the time of surgery, the patient reports data on demographics, lifestyle topics, comorbidity, and data on health-related quality of life such as Oswestry Disability Index, Euro-Qol-5D, and back and leg pain scores. The surgeon records diagnosis, type of surgery performed, and complications. One-year follow-ups are obtained with questionnaires. Baseline and 1-year follow-up data were analyzed to expose any differences between the countries.Results: A total of 1893 patients were included. At 1-year follow-up, 1315 (72%) patients responded. There were statistically significant baseline differences in age, smoking, comorbidity, frequency of previous surgery and intensity of back and leg pain. Isolated fusion was the primary procedure in all the countries ranging from 84% in Denmark to 76% in Sweden. There was clinically relevant improvement in all outcome measures except leg pain.Conclusions: In homogenous populations with similar health care systems the treatment traditions can vary considerably. Despite variations in preoperative variables, patient reported outcomes improve significantly and clinically relevant with surgical treatment.
|
|
| 3. |
- Lönne, Greger, et al.
(författare)
-
Lumbar spinal stenosis : comparison of surgical practice variation and clinical outcome in three national spine registries
- 2019
-
Ingår i: The spine journal. - : ELSEVIER SCIENCE INC. - 1529-9430 .- 1878-1632. ; 19:1, s. 41-49
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND CONTEXT: Decompression surgery for lumbar spinal stenosis (LSS) is the most common spinal procedure in the elderly. To avoid persisting low back pain, adding arthrodesis has been recommended, especially if there is a coexisting degenerative spondylolisthesis. However, this strategy remains controversial, resulting in practice-based variation.PURPOSE: The present study aimed to evaluate in a pragmatic study if surgical selection criteria and variation in use of arthrodesis in three Scandinavian countries can be linked to variation in treatment effectiveness.STUDY DESIGN: This is an observational study based on a combined cohort from the national spine registries of Norway, Sweden, and Denmark.PATIENT SAMPLE: Patients aged 50 and older operated during 2011-2013 for LSS were included.OUTCOME MEASURES: Patient-Reported Outcome Measures (PROMs): Oswestry Disability Index (ODI) (primary outcome). Numeric Rating Scale (NRS) for leg pain and back pain, and health-related quality of life (Euro-QoI-5D) were reported. Analysis included case-mix adjustment. In addition, we report differences in hospital stay.METHODS: Analyses of baseline data were done by analysis of variance (ANOVA), chi-square, or logistic regression tests. The comparisons of the mean changes of PROMs at 1-year follow-up between the countries were done by ANOVA (crude) and analysis of covariance (case-mix adjustment).RESULTS: Out of 14,223 included patients, 10.890 (77%) responded at 1-year follow-up. Apart from fewer smokers in Sweden and higher comorbidity rate in Norway. baseline characteristics were similar. The rate of additional fusion surgery (patients without or with spondylolisthesis) was 11% (4%, 47%) in Norway, 21% (9%, 56%) in Sweden, and 28% (15%, 88%) in Denmark. At 1-year follow-up, the mean improvement for ODI (95% confidence interval) was 18 (17-18) in Norway, 17 (17-18) in Sweden. and 18 (17-19) in Denmark. Patients operated with arthrodesis had prolonged hospital stay.CONCLUSIONS: Real-life data from three national spine registers showed similar indications for decompression surgery but significant differences in the use of concomitant arthrodesis in Scandinavia. Additional arthrodesis was not associated with better treatment effectiveness.
|
|
| 4. |
- Weber, Clemens, et al.
(författare)
-
Surgical management of lumbar spinal stenosis: a survey among Norwegian spine surgeons.
- 2017
-
Ingår i: Acta neurochirurgica. - : Springer Science and Business Media LLC. - 0942-0940 .- 0001-6268. ; 159:1, s. 191-7
-
Tidskriftsartikel (refereegranskat)abstract
- Symptomatic lumbar spinal stenosis (LSS) is the most common reason for lumbar surgery in the elderly. There is growing evidence that decompressive surgery offers an advantage over non-surgical management for selected patients with persistent severe symptoms. Based on treatment traditions, open laminectomy has been the gold standard surgical treatment, but various other surgical and non-surgical treatments for LSS are widely used in clinical practice. Therefore, we conducted a survey study to capture potential diversities in surgeons' management of LSS in Norway.All spine surgeons in Norway were contacted by e-mail and asked to answer a 20-item questionnaire by using an Internet-based survey tool. We asked eight questions about the respondent (gender, surgical specialty, workplace, experience, number of surgeries performed per year, use of magnification devices) and 12 questions about different aspects of the surgical treatment of LSS (indication for surgery and preoperative imaging, different surgical techniques, clinical outcome).The questionnaire was answered by 51 spine surgeons (47% response rate). The preferred surgical technique for LSS in Norway is microdecompression via a unilateral approach and crossover technique, followed by microdecompression via a bilateral approach. Other techniques are not much used in Norway.Most Norwegian spine surgeons use minimally invasive decompression techniques in the surgical treatment of LSS, and unilateral microsurgical decompression with crossover decompression is the preferred technique. Where evidence is lacking (e.g., fusion procedures), there is a larger variation of opinions and preferred procedures among Norwegian spine surgeons.
|
|
