Evaluation of Different Moxibustion Doses for Lumbar Disc Herniation: Multicentre Randomised Controlled Trial of Heat-Sensitive Moxibustion Therapy

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.

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 ◽  
...  

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.


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).


2022 ◽  
Author(s):  
Xian-Zhu Wang ◽  
Jin Cui ◽  
Jing FU ◽  
Kai-Yang Xue ◽  
Ping-Nan Chen ◽  
...  

Abstract Background Lumbar disc herniation (LDH) is a common and frequently-occurring disease in clinic. Low back pain and sciatica are the presenting symptoms of LDH. To some extent, it can be considered that measures with the capability to improve low back pain or sciatica have the potential to treat LDH. Ma's bamboo-based medicinal moxibustion therapy can effectively reduce the degree of low back pain and has been widely used. Studies of small sample size have seen significant improvement on pain relief. Methods/design: The trial is a multicenter, randomized, parallel-group, non-inferiority study. Three hundred and twelve patients will be randomly assigned to a Ma's bamboo-based medicinal moxibustion group (n=156) and an acupuncture group (n=156).Patients in each group will receive treatment every day,6 times a week, 12 times in total. Follow-up will be conducted 14 days after treatment. The primary outcome will be the visual analogue scale(VAS)at baseline, after 6 times of treatment,the end of treatment, and follow-up. the secondary outcomes will include Oswestry disability indexes (ODI) ,modified Japanese Orthopaedic Association low back pain (M-JOA) score,serum β-endorphin (β-EP) and serum substance P (SP). β-EP and SP as well as safety evaluation indexes (routine blood test, liver and kidney function, and ECG) will be measure at baseline and after the end of treatment. Discussion The results of the trial will compare the efficacy on low back pain in LDH between Ma's bamboo-based medicinal moxibustion group and acupuncture group and will be expected to make a systematic and objective evaluation on the clinical efficacy and safety of Ma's bamboo-based medicinal moxibustion therapy. Trial registration: ChiCTR, ChiCTR2000038725. Registered on 29 September 2020.


2021 ◽  
Author(s):  
Qilin Lu ◽  
Jin Tang ◽  
Long Chen ◽  
Xiao-zhen Wang ◽  
Yi-liang Zhu ◽  
...  

Abstract Background: Lumbar disc herniation (LDH) is a common spinal disorder. The discectomy with non-fusion operation is widely used. When the revision is needed, the options for revision way is still controversial. This study aims to introduce unilateral extraforaminal lumbar interbody fusion (ELIF) revision surgery, and to investigate the clinical efficacy and complication of Unilateral Extraforaminal Lumbar Interbody Fusion (ELIF) in revising primary discectomy for lumbar disc herniation. Methods:16 patients with incomplete removal and recurrence herniation of lumbar disc after minimally invasive treatment without fixation were treated by ELIF with unilateral pedicle screw(UPS) from April 2016 to October 2020. All those patietns including 11 male and 5 female aged 29-65 years were analyzed retrospectively. The clinical effects were evaluated by operation time, intraoperative blood loss, postoperative blood volume of drainage and complications. The Visual Analogue Scale(VAS), Oswestry Disability Index (ODI) were documented before, after surgery and at last follow--up. Results: The operation time was 95.73±10.5 min, the bleeding volume was 201.5±27.6 ml. Postoperative blood volume of drainage was 50.7±6.3 ml. 2 patients suffered dura tear. All patients were followed up for 12-26 months with 15.7 on average. VAS and ODI scores significantly improved at the preoperative, postoperative and the 12th month’s follow up (P < 0.05). Conclusion: The application of ELIF with unilateral fixation is a satisfied way to revise primary discectomy for lumbar disc herniation. However, the dura tear induced by scar tissue adhesion needs to be noticed.


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