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The effectiveness and safety of nonsurgical integrative interventions for symptomatic lumbar spinal spondylolisthesis: A randomized controlled multinational, multicenter trial protocol.

ABSTRACT: Surgery is generally accepted as the main therapeutic option for symptomatic lumbar spondylolisthesis. However, new nonsurgical therapeutic options need to be explored for this population.The objective of this study is to assess the effectiveness and safety of a 5-week Mokhuri treatment program compared with conventional nonsurgical treatments for symptomatic lumbar spondylolisthesis.This is a study protocol for a multinational, multicenter clinical randomized controlled trial comparing the effectiveness and safety of 5 weeks of nonsurgical integrative treatments (a Mokhuri treatment program consisting of Chuna, acupuncture, and patient education) with nonsurgical conventional treatments (drugs for pain relief, epidural steroid injections, and physical therapy). Clinical outcomes including visual analogue scale (VAS) scores ranging from 0 to 100 for low back pain and leg pain, EQ-5D scores, Oswestry disability index (ODI) scores, Roland-Morris Disability Questionnaire (RMDQ) scores, Zurich Claudication Questionnaire (ZCQ) scores, walking duration and distance without leg pain, and a 5-minute treadmill test, and the ratio between the actual duration of participation and the originally scheduled duration in each group, the presence of any additional spondylolisthesis treatments, the types of concomitant treatments during the follow-up period, and adverse events (AEs) will be assessed at 7 weeks, 18 weeks, 30 weeks, 54 weeks, and 102 weeks after the end of the treatments.The results of this study will provide clinical evidence on nonsurgical integrative interventions for patients with symptomatic lumbar spondylolisthesis. CLINICAL TRIAL REGISTRY:: clinicaltrials.gov (NCT03107468).

SUBMITTER: Kim K

PROVIDER: S-EPMC5959416 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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The effectiveness and safety of nonsurgical integrative interventions for symptomatic lumbar spinal spondylolisthesis: A randomized controlled multinational, multicenter trial protocol.

Kim Kiok K Youn Yousuk Y Lee Sang Ho SH Choi Jung Chul JC Jung Jae Eun JE Kim Jaehong J Qu Wenchun W Eldrige Jason J Kim Tae-Hun TH

Medicine 20180501 19

<h4>Background</h4>Surgery is generally accepted as the main therapeutic option for symptomatic lumbar spondylolisthesis. However, new nonsurgical therapeutic options need to be explored for this population.<h4>Objectives</h4>The objective of this study is to assess the effectiveness and safety of a 5-week Mokhuri treatment program compared with conventional nonsurgical treatments for symptomatic lumbar spondylolisthesis.<h4>Methods</h4>This is a study protocol for a multinational, multicenter c ...[more]

PMID: 29742708

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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:ImportanceLumbar spinal stenosis (LSS) is the most common reason for spine surgery in older US adults. There is an evidence gap about nonsurgical LSS treatment options.ObjectiveTo explore the comparative clinical effectiveness of 3 nonsurgical interventions for patients with LSS.Design, setting, and participantsThree-arm randomized clinical trial of 3 years' duration (November 2013 to June 2016). Analysis began in August 2016. All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat.InterventionsMedical care, group exercise, and manual therapy/individualized exercise. Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors in senior community centers. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists.Main outcomes and measuresPrimary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes).ResultsA total of 259 participants (mean [SD] age, 72.4 [7.8] years; 137 women [52.9%]) were allocated to medical care (88 [34.0%]), group exercise (84 [32.4%]), or manual therapy/individualized exercise (87 [33.6%]). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care (-2.0; 95% CI, -3.6 to -0.4) or group exercise (-2.4; 95% CI, -4.1 to -0.8). Manual therapy/individualized exercise had a greater proportion of responders (≥30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates.Conclusions and relevanceA combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity.Trial registrationClinicalTrials.gov Identifier: NCT01943435.

Project description:Study designA retrospective, observational study.ObjectiveThe aim of this study was to determine the utilization of various treatment modalities in the management of degenerative spondylolisthesis within Medicare beneficiaries.Summary of background dataDegenerative lumbar spondylolisthesis is a condition often identified in symptomatic low back pain. A variety of treatment algorithms including physical therapy and interventional techniques can be used to manage clinically significant degenerative spondylolisthesis.MethodsThis study utilized the 5% national sample of Medicare carrier claims from 2000 through 2011. A cohort of beneficiaries with a new International Classification of Diseases 9th edition (ICD-9) diagnosis code for degenerative lumbar spondylolisthesis was identified. Current procedural terminology codes were used to identify the number of procedures performed each year by specialty on this cohort.ResultsA total of 95,647 individuals were included in the analysis. Average age at the time of initial diagnosis was 72.8 ± 9.8 years. Within this study cohort, spondylolisthesis was more prevalent in females (69%) than males and in Caucasians (88%) than other racial demographics. Over 50% of beneficiaries underwent at least one injection, approximately one-third (37%) participated in physical therapy, one in five (21%) underwent spinal surgery, and one-third (36%) did not utilize any of these interventions. Greater than half of all procedures (124,280/216,088) occurred within 2 years of diagnosis. The ratio of focal interventions (transforaminal and facet interventions) to less selective (interlaminar) procedures was greater for the specialty of Physical Medicine and Rehabilitation than for the specialties of Anesthesiology, Interventional Radiology, Neurosurgery, and Orthopedic Surgery. The majority of physical therapy was dedicated to passive treatment modalities and range of motion exercises rather than active strengthening modalities within this cohort.ConclusionInterventional techniques and physical therapy are frequently used treatment modalities for symptomatic degenerative spondylolisthesis. Understanding utilization of these techniques is important to determine relative clinical efficacies and to optimize future health care expenditures.Level of evidenceN/A.

Project description:BackgroundThere have been lingering controversies reported decompression and plus fusion. And the relative safety of fusion in addition to standard decompression remains unclear. This study aimed to assess the effectiveness and safety of decompression alone or combined with fusion in lumbar spinal stenosis (LSS) with degenerative spondylolisthesis (DS).MethodsIn this systematic review and meta-analysis, we searched the databases of PubMed, Embase, Cochrane Library, and Web of Science for relevant literature from their inception to 28th December 2021. We identified the eligible studies based on the PICOS principles, populations (LSS with DS), interventions (decompression alone), controls (decompression combined with fusion), outcomes [overall reoperation rate, complications, Oswestry Disability Index (ODI), operative time, the amount of blood lost, length of stay (LOS), and visual analog scales (VAS)], study design (cohort studies). Quality assessment for individual study was performed with the Newcastle-Ottawa Scale (NOS).ResultsIn all, 12 articles involving a total of 14,693 patients were finally included in the study, the majority of patients underwent decompression alone (DA group: n=11,598) and the rest underwent decompression associated with fusion (FU group: n=3,095). The quality of most of the included studies was regarded as high quality. The results indicated that the FU group had a higher rate of complication [relative risk (RR): 1.770, 95% confidence interval (CI): 1.485 to 2.110], longer operative time [weighted mean difference (WMD): 51.037, 95% CI: 13.743 to 88.330], and increased blood loss (WMD: 258.354, 95% CI: 150.468 to 366.239) than the DA group (all P<0.05), with no significant differences for overall reoperation rate (RR: 0.879, 95% CI: 0.432 to 1.786), ODI (WMD: -2.569, 95% CI: -6.548 to 1.409), LOS (WMD: 3.838, 95% CI: -2.172 to 9.848), and VAS found between the two groups (P>0.05).ConclusionsIn patients with LSS + DS, the effectiveness and safety of decompression alone may be superior to decompression plus fusion in terms of complication rate, operative time, and the amount of bleeding. However, more high-quality literature is needed in the future to confirm the best treatment choice for patients with LSS + DS.

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.

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.

Dataset Information

The effectiveness and safety of nonsurgical integrative interventions for symptomatic lumbar spinal spondylolisthesis: A randomized controlled multinational, multicenter trial protocol.

Publications

The effectiveness and safety of nonsurgical integrative interventions for symptomatic lumbar spinal spondylolisthesis: A randomized controlled multinational, multicenter trial protocol.

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