scholarly journals Evaluation of the efficacy and safety of conventional and biportal endoscopic decompressive laminectomy in patients with lumbar spinal stenosis (ENDO-B trial): a protocol for a prospective, randomized, assessor-blind, multicenter trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Hyun-Jin Park ◽  
Sang-Min Park ◽  
Kwang-Sup Song ◽  
Ho-Joong Kim ◽  
Si-Young Park ◽  
...  
Keyword(s):  
Spinal Stenosis ◽  
Lumbar Spinal Stenosis ◽  
Controlled Trial ◽  
Small Sample ◽  
Endoscopic Technique ◽  
Efficacy And Safety ◽  
Research Information ◽  
Level Of Evidence ◽  
Decompressive Laminectomy ◽  
Lumbar Spinal

Abstract Background Recent studies on biportal endoscopic spine surgery in patients with lumbar spinal stenosis have reported good clinical results. However, these studies have been limited by the small sample sizes and use of a retrospective study design. Therefore, we aim to compare the efficacy and safety of biportal endoscopic decompressive laminectomy with those of conventional decompressive laminectomy in a multicenter, prospective, randomized controlled trial. Methods This study will include 120 patients (60 per group, aged 20–80 years) with 1- or 2-level lumbar spinal stenosis, who will be recruited from six hospitals. The study will be conducted from July 2021 to December 2024. The primary outcome (Oswestry Disability Index at 12 months after surgery) will be evaluated through a modified intention-to-treat method. The secondary outcomes will include the following: visual analog scale score for low back and lower extremity radiating pain, EuroQol 5-dimensions score, surgery satisfaction, walking time, postoperative return to daily life period, postoperative surgical scars, and some surgery-related variables. Radiographic outcomes will be analyzed using magnetic resonance imaging or computed tomography. All outcomes will be evaluated before the surgery and at 2 weeks, 3 months, 6 months, and 12 months postoperatively. This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for reporting of clinical trial protocols. Discussion It is hypothesized that the efficacy and safety of biportal endoscopic and conventional decompressive laminectomy will be comparable in patients with lumbar spinal stenosis. The results of this trial will provide a high level of evidence for the efficacy and safety of the biportal endoscopic technique in patients with lumbar spinal stenosis and facilitate the development of clinical practice guidelines. Furthermore, the results of this study may indicate the feasibility of the biportal endoscopic technique for other types of spinal surgery. Trial registration The ENDO-B trial is registered at Clinical Research Information Service (CRIS, cris.nih.go.kr) (KCT0006057; April 52,021).

scholarly journals Effect of TENS Versus Placebo on Walking Capacity in Patients With Lumbar Spinal Stenosis: A Protocol for a Randomized Controlled Trial

2016 ◽  
Vol 15 (3) ◽  
pp. 197-203 ◽  
Author(s):  
Carlo Ammendolia ◽  
Pierre Côté ◽  
Y. Raja Rampersaud ◽  
Danielle Southerst ◽  
Brian Budgell ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Spinal Stenosis ◽  
Lumbar Spinal Stenosis ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Walking Capacity ◽  
Lumbar Spinal

scholarly journals The relationship between preoperative predictive factors for clinical outcome in patients operated for lumbar spinal stenosis by decompressive laminectomy

2020 ◽  
Vol 11 ◽  
pp. 27 ◽  
Author(s):  
Dobran Mauro ◽  
Davide Nasi ◽  
Riccardo Paracino ◽  
Mara Capece ◽  
Erika Carrassi ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Spinal Stenosis ◽  
Lumbar Spinal Stenosis ◽  
Predictive Factors ◽  
Antidepressant Drugs ◽  
Decompressive Laminectomy ◽  
Pain Anxiety ◽  
Pain Medications ◽  
Improved Outcomes ◽  
Lumbar Spinal

Background: Our hypothesis was that by identifying certain preoperative predictive factors, we could favorably impact clinical outcomes in patients undergoing decompressive surgery for lumbar spinal stenosis (LSS). Methods: In this retrospective study, there were 65 patients (2016–2018) with symptomatic LSS who underwent decompressive laminectomy without fusion. Their clinical outcomes were assessed utilizing the Oswestry Disability Index (ODI). Multiple preoperative variables were studied to determine which ones would help predict improved outcomes: gender, age, body mass index (BMI), general/neurological examination, smoking, and drug therapies (anxiolytics and/or antidepressants). Results: All patients demonstrated statistically significant improvement on the ODI. Multivariate analysis revealed that those with higher preoperative BMI had significantly lower ODI on 1-year follow-up examinations, reflecting poorer outcomes. Postoperatively, 44 patients (67%) exhibited lower utilization of anxiolytic medications, 52 patients (80%) showed reduced use of antidepressant drugs, and pain medications utilization was reduced in 33 patients (50%). Conclusion: Decompressive laminectomy without fusion effectively managed LSS. It reduced patients’ use of pain, anxiety, and antidepressant medications. In addition, we found that increased preoperative BMIs contributed to poorer postoperative outcomes (e.g., ODI values).

scholarly journals The boot camp program for lumbar spinal stenosis: a protocol for a randomized controlled trial

2016 ◽  
Vol 24 (1) ◽  
Author(s):  
Carlo Ammendolia ◽  
Pierre Côté ◽  
Y. Raja Rampersaud ◽  
Danielle Southerst ◽  
Brian Budgell ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Spinal Stenosis ◽  
Lumbar Spinal Stenosis ◽  
Controlled Trial ◽  
Boot Camp ◽  
Randomized Controlled ◽  
Lumbar Spinal

scholarly journals Comparable increases in dural sac area after three different posterior decompression techniques for lumbar spinal stenosis: radiological results from a randomized controlled trial in the NORDSTEN study

2020 ◽  
Vol 29 (9) ◽  
pp. 2254-2261
Author(s):  
Erland Hermansen ◽  
Ivar Magne Austevoll ◽  
Christian Hellum ◽  
Kjersti Storheim ◽  
Tor Åge Myklebust ◽  
...  
Keyword(s):  
Spinal Stenosis ◽  
Lumbar Spinal Stenosis ◽  
Controlled Trial ◽  
Spinous Process ◽  
Surgical Techniques ◽  
Posterior Decompression ◽  
Clinical Trial Registration ◽  
Dural Sac ◽  
Radiological Results ◽  
Lumbar Spinal

Abstract Purpose To investigate changes in dural sac area after three different posterior decompression techniques in patients undergoing surgery for lumbar spinal stenosis. Summary of background data Decompression of the nerve roots is the main surgical treatment for lumbar spinal stenosis. The aim of this study was to radiologically investigate three commonly used posterior decompression techniques. Methods The present study reports data from one of two multicenter randomized trials included in the NORDSTEN study. In the present trial, involving 437 patients undergoing surgery, we report radiological results after three different midline retaining posterior decompression techniques: unilateral laminotomy with crossover (UL) (n = 146), bilateral laminotomy (BL) (n = 142) and spinous process osteotomy (SPO) (n = 149). MRI was performed before and three months after surgery. The increase in dural sac area and Schizas grade at the most stenotic level was evaluated. Three different predefined surgical indicators of substantial decompression were used: (1) postoperative dural sac area of > 100 mm2, (2) increase in the dural sac area of at least 50% and (3) postoperative Schizas grade A or B. Results No differences between the three surgical groups were found in the mean increase in dural sac area. Mean values were 66.0 (SD 41.5) mm2 in the UL-group, 71.9 (SD 37.1) mm2 in the BL-group and 68.1 (SD 41.0) mm2 in the SPO-group (p = 0.49). No differences in the three predefined surgical outcomes between the three groups were found. Conclusion For patients with lumbar spinal stenosis, the three different surgical techniques provided the same increase in dural sac area. Clinical trial registration The study is registered at ClinicalTrials.gov reference on November 22th 2013 under the identifier NCT02007083.

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