Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial

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.

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PTED study: design of a non-inferiority, randomised controlled trial to compare the effectiveness and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) versus open microdiscectomy for patients with a symptomatic lumbar disc herniation

BMJ Open ◽

10.1136/bmjopen-2017-018230 ◽

2017 ◽

Vol 7 (12) ◽

pp. e018230 ◽

Cited By ~ 9

Author(s):

Ankie Seiger ◽

Pravesh S Gadjradj ◽

Biswadjiet S Harhangi ◽

Job LC van Susante ◽

Wilco C. Peul ◽

...

Keyword(s):

Economic Evaluation ◽

Cost Effectiveness ◽

Lumbar Disc Herniation ◽

Disc Herniation ◽

Primary Outcome ◽

Controlled Trial ◽

Lumbar Disc ◽

Endoscopic Discectomy ◽

Percutaneous Transforaminal Endoscopic Discectomy ◽

Randomised Controlled

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.

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Surgery versus conservative management for lumbar disc herniation with radiculopathy: A systematic review and meta-analysis

Journal of Health Sciences ◽

10.17532/jhsci.2018.479 ◽

2018 ◽

Vol 8 (1) ◽

pp. 42-53 ◽

Cited By ~ 3

Author(s):

Musa Sani Dan-Azumi ◽

Bashir Bello ◽

Salim Ahmad Rufai ◽

Mamuda Alhaji Abdulrahman

Keyword(s):

Lumbar Disc Herniation ◽

Disc Herniation ◽

Conservative Management ◽

Lumbar Disc ◽

Meta Analysis ◽

Term Effect ◽

Early Surgery ◽

Short Term ◽

Conservative Care

Introduction: Lumbar Disk Herniation with Radiculopathy (LDHR) appears to be a large and costly problem. The paradigm regarding the best treatment for LDHR has being between surgery and conservative management. The aim of this study was to compare and summarize evidence regarding the effectiveness of surgery and conservative treatment for individuals with sciatica due to lumbar disc herniation. Methods: This study reviewed all literatures published on individuals with LDHR, who were managed either via surgery or conservative method. Pain and functional disability were the main outcome measures analyzed. A comprehensive search of PubMed, TRIP, PEDro and CINAHL was conducted from October, 2011 to June 2017. Two independent researchers selected the studies, and extracted the data. Methodological quality was assessed using the PEDro scale. Meta-analysis was carried out where suitable. Results: Eight studies involving (n=1,507) were included in the review. Meta-analysis was conducted for only 4 studies (n=784). The meta-analysis showed significant benefit for early surgery than conservative care -8.01(95% CI, -9.27 to -6.72) in the short-term effect -0.49 (95% CI, -0.7 to -0.28). However, the result for long-term effect did not show any significant difference between surgery and conservative care 1.60 (95% CI, -6.85 to 10.05). Conclusion: This current evidence suggest that early surgery for individuals with lumbar disc herniation with radiculopathy is better than conservative care in the short-term without any long-term difference. The results of this review should be interpreted with caution as the populations of the included studies were largely heterogeneous.

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