Dataset Information

The clinical efficacy of Shi-style lumbar manipulations for symptomatic degenerative lumbar spondylolisthesis: protocol for a randomized, blinded, controlled trial.

ABSTRACT:

Background

Symptomatic degenerative lumbar spondylolisthesis (DLS) presents spinal problems in daily life. Shi-style lumbar manipulation (SLM), as an alternative treatment for DLS, is popular in China. SLM is based on the channels and collaterals theory of the traditional Chinese medicine, in which the symptoms are believed to result from channel blockage and joint displacement. However, there is no solid evidence to show the effect of the SLM on the management of symptomatic DLS.

Methods/design

We conduct a prospective randomized, blinded, controlled trial to compare the effectiveness of SLM with mechanical lumbar traction and explore whether it could be a potential therapy for symptomatic DLS. A total of 60 patients with symptomatic DLS will be enrolled and treated with the SLM or mechanical lumbar traction for 2?weeks. VAS score and SF-36 questionnaire were assessed at baseline and at 2, 4, 12, and 24?weeks. Any signs of acute adverse reactions, such as lower limb paralysis or syndrome of cauda equina, will be recorded at each visit during treatment.

Discussion

Although the SLM has been used in China for many years to treat symptomatic DLS, there is a lack of consensus about its effectiveness. This trial will provide convincing evidence about the effect of SLM on symptomatic DLS.

Trial registration

Registered on 6 January 2019; the trial number is ChiCTR1900020519 .

SUBMITTER: Yin M

PROVIDER: S-EPMC6567571 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Publications

The clinical efficacy of Shi-style lumbar manipulations for symptomatic degenerative lumbar spondylolisthesis: protocol for a randomized, blinded, controlled trial.

Yin Mengchen M Ye Jie J Xue Ruirui R Qiao Liang L Ma Junming J Mo Wen W

Journal of orthopaedic surgery and research 20190614 1

<h4>Background</h4>Symptomatic degenerative lumbar spondylolisthesis (DLS) presents spinal problems in daily life. Shi-style lumbar manipulation (SLM), as an alternative treatment for DLS, is popular in China. SLM is based on the channels and collaterals theory of the traditional Chinese medicine, in which the symptoms are believed to result from channel blockage and joint displacement. However, there is no solid evidence to show the effect of the SLM on the management of symptomatic DLS.<h4>Met ...[more]

PMID: 31200736

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Project description:BackgroundManagement of degenerative spondylolisthesis with spinal stenosis is controversial. Surgery is widely used, but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials.MethodsSurgical candidates from 13 centers in 11 U.S. states who had at least 12 weeks of symptoms and image-confirmed degenerative spondylolisthesis were offered enrollment in a randomized cohort or an observational cohort. Treatment was standard decompressive laminectomy (with or without fusion) or usual nonsurgical care. The primary outcome measures were the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) bodily pain and physical function scores (100-point scales, with higher scores indicating less severe symptoms) and the modified Oswestry Disability Index (100-point scale, with lower scores indicating less severe symptoms) at 6 weeks, 3 months, 6 months, 1 year, and 2 years.ResultsWe enrolled 304 patients in the randomized cohort and 303 in the observational cohort. The baseline characteristics of the two cohorts were similar. The one-year crossover rates were high in the randomized cohort (approximately 40% in each direction) but moderate in the observational cohort (17% crossover to surgery and 3% crossover to nonsurgical care). The intention-to-treat analysis for the randomized cohort showed no statistically significant effects for the primary outcomes. The as-treated analysis for both cohorts combined showed a significant advantage for surgery at 3 months that increased at 1 year and diminished only slightly at 2 years. The treatment effects at 2 years were 18.1 for bodily pain (95% confidence interval [CI], 14.5 to 21.7), 18.3 for physical function (95% CI, 14.6 to 21.9), and -16.7 for the Oswestry Disability Index (95% CI, -19.5 to -13.9). There was little evidence of harm from either treatment.ConclusionsIn nonrandomized as-treated comparisons with careful control for potentially confounding baseline factors, patients with degenerative spondylolisthesis and spinal stenosis treated surgically showed substantially greater improvement in pain and function during a period of 2 years than patients treated nonsurgically. (ClinicalTrials.gov number, NCT00000409 [ClinicalTrials.gov].).

Project description:BackgroundClinically, there are substantive practice variations in surgical management of degenerative lumbar spondylolisthesis. We aimed at evaluating whether decompression alone outcomes for patients with degenerative lumbar spondylolisthesis are comparable to those of decompression with fusion.MethodsIn this meta-analysis, the Embase, PubMed, and Cochrane Library databases were searched from inception to February 16th, 2022. Randomised controlled trials (RCTs) and cohort studies comparing decompression alone with decompression and fusion for patients with degenerative lumbar spondylolisthesis were included in this study. There were no language limitations. Odds ratio (OR), mean difference (MD) and 95% confidence interval (CI) were used to report results in the random-effects model. Main outcomes included Oswestry disability index (ODI), pain, clinical satisfaction, complication and reoperation rates. The study protocol was published in PROSPERO (CRD42022310645).FindingsThirty-three studies (6 RCTs and 27 cohort studies) involving 94 953 participants were included. Differences in post-operative ODI between decompression alone and decompression with fusion were not significant. A small difference for back (MD, 0.13; [95% CI, 0.08 to 0.18]; I 2:0.00%) and leg pain (MD, 0.30; [95% CI, 0.09 to 0.51]; I 2:48.35%) was observed on the 3rd post-operative month. The results did not reveal significant differences in leg pain and back pain between decompression alone and fusion groups on the 6th, 12th, and 24th post-operative months. Difference in clinical satisfaction between decompression alone and decompression with fusion were not significant from RCTs (OR, 0.26; [95% CI, 0.03 to 1.92]; I 2:83.27%). Complications (OR, 1.54; [95% CI, 1.16 to 2.05]; I 2:48.88%), operation time (MD, 83.39; [95% CI, 55.93 to 110.85]; I 2:98.75%), intra-operative blood loss (MD, 264.58; [95% CI, 174.99 to 354.16]; I 2:95.61%) and length of hospital stay (MD, 2.85; [95% CI, 1.60 to 4.10]; I 2:99.49%) were higher with fusion.InterpretationClinical effectiveness of decompression alone was comparable to that of decompression with fusion for degenerative lumbar spondylolisthesis. Decompression alone is recommended for patients with degenerative lumbar spondylolisthesis.FundingThis work was supported by grants from the National Natural Science Foundation of China (No. 81871818), Tangdu Hospital Seed Talent Program (Fei-Long Wei), Natural Science Basic Research Plan in Shaanxi Province of China (No.2019JM-265) and Social Talent Fund of Tangdu Hospital (No.2021SHRC034).

Project description:BackgroundInferior clinical outcomes have been reported in patients with degenerative lumbar spondylolisthesis (DLS) accompanied by lumbar degenerative scoliosis, but little attention has been paid to its radiologic assessment or preoperative planning. The aim of this study was to analyze the effect of transforaminal lumbar interbody fusion on patients with DLS and lumbar degenerative scoliosis and explore the surgical aspects benefiting the restoration of lumbar degenerative scoliosis.MethodsAll patients with DLS and lumbar degenerative scoliosis undergoing single-level unilateral transforaminal lumbar interbody fusion surgery between July 1, 2015, and April 30, 2021, were screened in this retrospective cohort study. Clinical outcomes including visual analog scale (VAS), Oswestry disability index (ODI), and radiographic parameters of sagittal and coronal alignment, cage spatial locations, and angle of pedicle screw (parallel, cranial, and caudad angle) were assessed. Coronal asymmetry was demonstrated by the intervertebral height difference between the medial and lateral margins of indexed intersegmental space. The correlations between Δintervertebral height difference (postoperative intervertebral height difference-preoperative intervertebral height difference) and radiographic parameters and clinical outcomes were analyzed by univariable, multivariable, mediation, and correlation analyses. Significance was set at a bilateral P<0.05.ResultsA total of 57 included patients were followed up for a minimum of 1 year. Reduction of VAS, ODI, and improvement of radiographic parameters were found after surgery. The cranial angle of the lower pedicle screw positively correlated with Δintervertebral height difference restoration (b=0.54; standard error=0.11; P<0.001).ConclusionsTransforaminal lumbar interbody fusion surgery appears to be an effective approach to improving the radiographic and clinical outcomes of patients with DLS and lumbar degenerative scoliosis. The cranial direction of the lower pedicle screws in single-level unilateral transforaminal lumbar interbody fusion surgery may be associated with a better postoperative restoration of lumbar degenerative scoliosis.

Project description:BackgroundPedicle screw invasion of the proximal articular process will cause local articular process degeneration and acceleration, which is an important factor affecting adjacent segment degeneration. Although lumbar spondylolisthesis is a risk factor for screw invasion of the proximal joint, there is no clear conclusion regarding the two different types of spondylolisthesis. Therefore, the purpose of this study was to explore the influence of pedicle screw placement on proximal facet invasion in the treatment of degenerative spondylolisthesis and isthmic spondylolisthesis.MethodsIn total, 468 cases of lumbar spondylolisthesis treated by decompression and fusion in our hospital from January 2017 to January 2020 were included in this retrospective study. Among them, 238 cases were degenerative spondylolisthesis (group A), and 230 cases were isthmic spondylolisthesis (group B). Sex, age, body mass index, bone mineral density, preoperative visual analog scale (VAS) and Oswestry Disability Index (ODI) scores, postoperative VAS and ODI scores at 1 month and 3 months, and angle of the proximal facet joint at the last follow-up were recorded and compared between the two groups. The degree of pedicle screw invasion of the proximal facet joint was graded and compared by the SEO grading method.ResultsThere were no significant differences in sex, age, body mass index, bone mineral density, preoperative VAS and ODI scores, or proximal facet joint angle between the two groups (P > 0.05). There was no significant difference in VAS and ODI scores between the two groups at 1 month and 3 months after the operation (P > 0.05). The VAS score of group A at the last follow-up was 1 (1,2). The VAS score of group B at the last follow-up was 3 (1,3). The ODI score of group A at the last follow-up was 6(4,26). The ODI score of group B at the last follow-up was 15(8,36). The VAS and ODI scores of the two groups at the last follow-up were significantly different (P < 0.05). According to the SEO grading method, the invasion of the proximal articular process by pedicle screw placement in group A involved 320 cases in grade 0, 128 cases in grade I and 28 cases in grade II. In group B, there were 116 cases in grade 0, 248 cases in grade I and 96 cases in grade II, with a significant difference (P < 0.01).ConclusionIn summary, a certain number of cases involving screws invading the proximal facet joint occurred in the two different types of lumbar spondylolisthesis, but the number in the isthmic spondylolisthesis group was significantly higher than that in the degenerative spondylolisthesis group, which caused more trauma to the proximal facet joint and significantly affected the patient prognosis.

Project description:ObjectiveTo systematically evaluate the difference in clinical efficacy between two surgical approaches, oblique lateral approach and intervertebral foraminal approach, in the treatment of degenerative lumbar spondylolisthesis.MethodsEnglish databases, including PubMed, Cochrane, Embase, and Web of Science, were systematically searched using keywords such as "oblique lumbar interbody fusion" and "transforaminal lumbar interbody fusion." Concurrently, Chinese databases, including CNKI, WanFang data, VIP, and CBM, were also queried using corresponding Chinese terms. The search spanned from January 2014 to February 2024, focusing on published studies in both Chinese and English that compared the clinical efficacy of OLIF and TLIF. The literature screening was conducted by reviewing titles, abstracts, and full texts. Literature meeting the inclusion criteria underwent quality assessment, and relevant data were extracted. Statistical analysis and a meta-analysis of the observational data for both surgical groups were performed using Excel and RevMan 5.4 software. Findings revealed a total of 14 studies meeting the inclusion criteria, encompassing 877 patients. Of these, 414 patients were in the OLIF group, while 463 were in the TLIF group. Meta-analysis of the statistical data revealed that compared to TLIF, OLIF had a shorter average surgical duration (P < 0.05), reduced intraoperative bleeding (P < 0.05), shorter average hospital stay (P < 0.05), better improvement in postoperative VAS scores (P < 0.05), superior enhancement in postoperative ODI scores (P < 0.05), more effective restoration of disc height (P < 0.05), and better correction of lumbar lordosis (P < 0.05). However, there were no significant differences between OLIF and TLIF in terms of the incidence of surgical complications (P > 0.05) and fusion rates (P > 0.05).ConclusionWhen treating degenerative lumbar spondylolisthesis, OLIF demonstrates significant advantages over TLIF in terms of shorter surgical duration, reduced intraoperative bleeding, shorter hospital stay, superior improvement in postoperative VAS and ODI scores, better restoration of disc height, and more effective correction of lumbar lordosis.

Project description:ImportanceConflicting evidence and large practice variation are present in the surgical treatment of degenerative spondylolisthesis. More than 90% of surgical procedures in the United States include instrumented fusion compared with 50% or less in other countries.ObjectiveTo evaluate whether the effectiveness of microdecompression alone is noninferior to decompression with instrumented fusion in a real-world setting.Design, setting, and participantsThis multicenter comparative effectiveness study with a noninferiority design assessed prospective data from the Norwegian Registry for Spine Surgery. From September 19, 2007, to December 21, 2015, 1376 patients at 35 Norwegian orthopedic and neurosurgical departments underwent surgery for lumbar spinal stenosis with degenerative spondylolisthesis without scoliosis. After excluding patients undergoing laminectomy alone, fusion without instrumentation, or surgery in more than 2 levels and those with a former operation at the index level, 794 patients were included in the analyses, regardless of missing or incomplete follow-up data, before propensity score matching. Data were analyzed from March 20 to October 30, 2018.ExposuresMicrodecompression alone or decompression with instrumented fusion.Main outcomes and measuresA reduction from baseline of 30% or greater in the Oswestry Disability Index at 12-month follow-up.ResultsAfter propensity score matching, 570 patients (413 female [72%]; mean [SD] age, 64.7 [9.5] years) were included for comparison, with 285 undergoing microdecompression (mean [SD] age, 64.6 [9.8] years; 205 female [72%]) and 285 undergoing decompression with instrumented fusion (mean [SD] age, 64.8 [9.2] years; 208 female [73%]). The proportion of each type of procedure varied between departments. However, changes in outcome scores varied within patients but not between departments. The proportion of patients with improvement in the Oswestry Disability Index of at least 30% was 150 of 219 (68%) in the microdecompression group and 155 of 215 (72%) in the instrumentation group. The 95% CI (-12% to 5%) for the difference of -4% was above the predefined margin of noninferiority (-15%). Microdecompression alone was associated with shorter operation time (mean [SD], 89 [44] vs 180 [65] minutes; P < .001) and shorter hospital stay (mean [SD], 2.5 [2.4] vs 6.4 [3.0] days; P < .001).Conclusions and relevanceAmong patients with degenerative spondylolisthesis, the clinical effectiveness of microdecompression alone was noninferior to that of decompression with instrumented fusion. Microdecompression alone was also associated with shorter durations of surgery and hospital stay, supporting the suggestion that the less invasive procedure should be considered for most patients.

Dataset Information

The clinical efficacy of Shi-style lumbar manipulations for symptomatic degenerative lumbar spondylolisthesis: protocol for a randomized, blinded, controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

The clinical efficacy of Shi-style lumbar manipulations for symptomatic degenerative lumbar spondylolisthesis: protocol for a randomized, blinded, controlled trial.

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