scholarly journals Cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in the treatment of lumbar disc herniation: a prospective randomised controlled trial [ISRCTN51857546]

2006 ◽  
Vol 7 (1) ◽  
Author(s):  
Mark P Arts ◽  
Wilco C Peul ◽  
Ronald Brand ◽  
Bart W Koes ◽  
Ralph TWM Thomeer
BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018230 ◽  
Author(s):  
Ankie Seiger ◽  
Pravesh S Gadjradj ◽  
Biswadjiet S Harhangi ◽  
Job LC van Susante ◽  
Wilco C. Peul ◽  
...  

IntroductionLumbosacral radicular syndrome is often caused by a disc herniation. The standard surgical technique to remove a disc herniation is open microdiscectomy. An alternative technique is percutaneous transforaminal endoscopic discectomy (PTED), which is less invasive. In the Netherlands, PTED is not currently considered as standard care, and therefore not reimbursed within public health insurance. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been designed to determine the effectiveness and cost-effectiveness of PTED versus open microdiscectomy for the treatment of lumbar disc herniation.Method and analysisIn total, 682 patients between 18 and 70 years of age with >10 weeks of radiating pain or with >6 weeks of excessive radiating pain are to be recruited from participating centres. Patients must have an indication for surgery based on an MRI demonstrating compression of the nerve root from a lumbar disc herniation. Patients are to be randomised to PTED or open microdiscectomy. The primary outcome is self-reported leg pain measured by the 0–100 mm Visual Analogue Scale. Secondary outcomes include self-reported health and functional status, back pain, self-perceived recovery and a physical examination. Outcomes will be measured the day following surgery, at 2, 4 and 6 weeks, and at 3, 6, 9, 12 and 24 months. Physical examination will be performed at 6 weeks, and 3 and 12 months. An economic evaluation will be performed from a societal perspective and cost questionnaires will be used (eg, EQ-5D-5L). The data will be analysed longitudinally; the non-inferiority margin for the primary outcome is 5. Bootstrapping techniques will be used for the economic evaluation.Ethics and disseminationThis study has received approval of the Medical Ethical Committee of the VU Medical Centre Amsterdam: NL50951.029.14. The results will be published in an international peer-reviewed scientific journal.Trial registration numberNCT02602093; Pre-results, recruiting stage.


BMJ ◽  
2008 ◽  
Vol 336 (7657) ◽  
pp. 1355-1358 ◽  
Author(s):  
Wilco C Peul ◽  
Wilbert B van den Hout ◽  
Ronald Brand ◽  
Ralph T W M Thomeer ◽  
Bart W Koes ◽  
...  

2012 ◽  
Vol 30 (4) ◽  
pp. 266-272 ◽  
Author(s):  
Mingren Chen ◽  
Rixin Chen ◽  
Jun Xiong ◽  
Zhenhai Chi ◽  
Jianhua Sun ◽  
...  

Background There is some evidence for the effectiveness of moxibustion for the treatment of lumbar disc herniation (LDH), but it remains unclear what dose is optimal. Objective To compare the effectiveness of a new technique of individualised ‘sensitivity elimination’ dose versus a standardised 15 min dose in the treatment of LDH. Methods This study was a multicentre (four centres in China), randomised, controlled trial with two parallel arms (group A, individualised sensitivity elimination dose; group B, standardised dose). The most heat-sensitised acupuncture point from the triangle bound by BL25 and GV2 was selected. Both groups received 18 sessions over 2 weeks. The outcome was evaluated by Modified Japanese Orthopaedic Association scale (M-JOA) score before and after treatment and at 6-month follow-up examination. All main analyses were by intention to treat. Results A total of 96 patients were included. A Significant difference of total M-JOA score was noted between the groups at weeks 1 and 2 (p<0.05). Significant differences were also evident during the follow-up period (p<0.01). The mean duration of moxibustion was 42.7±5.4 (range, 22–58) minutes in the experimental group. Conclusions The effectiveness of the individualised sensitivity elimination dose appears superior to the standardised dose in the treatment of LDH. Only 15 min moxibustion in the conventional dose group seemed insufficient to elicit the satisfactory clinical effects obtained by heat-sensitive moxibustion therapy. However, in view of some limitations of this study further research is necessary before this can be stated conclusively. Trial Registration Controlled Clinical Trials: ChiCTR-TRC-09000602.


2018 ◽  
Vol 28 (3) ◽  
pp. 300-310 ◽  
Author(s):  
Zihao Chen ◽  
Liangming Zhang ◽  
Jianwen Dong ◽  
Peigen Xie ◽  
Bin Liu ◽  
...  

OBJECTIVEA prospective randomized controlled study was conducted to clarify whether percutaneous transforaminal endoscopic discectomy (PTED) results in better clinical outcomes and less surgical trauma than microendoscopic discectomy (MED).METHODSIn this single-center, open-label, randomized controlled trial, patients were included if they had persistent signs and symptoms of radiculopathy with corresponding imaging-confirmed lumbar disc herniation. Patients were randomly allocated to the PTED or the MED group by computer-generated randomization codes. The primary outcome was the Oswestry Disability Index (ODI) score 1 year after surgery. Secondary outcomes included scores of the Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain and physical function scales, EuroQol Group’s EQ-5D , and the visual analog scales for back pain and leg pain. Data including duration of operation, in-bed time, length of hospital stay, surgical cost and total hospital cost, complications, and reoperations were recorded.RESULTSA total of 153 participants were randomly assigned to 2 treatment groups (PTED vs MED), and 89.5% (137 patients) completed 1 year of follow-up. Primary and secondary outcomes did not differ significantly between the treatment groups at each prespecified follow-up point (p > 0.05). For PTED, there was less postoperative improvement in ODI score in the median herniation subgroup at 1 week (p = 0.027), 3 months (p = 0.013), 6 months (p = 0.027), and 1 year (p = 0.028) compared with the paramedian subgroup. For MED, there was significantly less improvement in ODI score at 3 months (p = 0.008), 6 months (p = 0.028), and 1 year (p = 0.028) in the far-lateral herniation subgroup compared with the paramedian subgroup. The total complication rate over the course of 1 year was 13.75% in the PTED group and 16.44% in the MED group (p = 0.642). Five patients (6.25%) in the PTED group and 3 patients (4.11%) in the MED group suffered from residue/recurrence of herniation, for which reoperation was required.CONCLUSIONSOver the 1-year follow-up period, PTED did not show superior clinical outcomes and did not seem to be a safer procedure for patients with lumbar disc herniation compared with MED. PTED had inferior results for median disc herniation, whereas MED did not seem to be the best treatment option for far-lateral disc herniation.Clinical trial registration no.: NCT01997086 (clinicaltrials.gov).


Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 39-LB
Author(s):  
DEBORAH MARY BROADBENT ◽  
AMU WANG ◽  
CHRISTOPHER P. CHEYNE ◽  
JAMES G. LATHE ◽  
IRENE M. STRATTON ◽  
...  

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