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2,096 result(s) for "Lumbosacral Region"
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The Effectiveness and Safety of Utilizing Mobile Phone–Based Programs for Rehabilitation After Lumbar Spinal Surgery: Multicenter, Prospective Randomized Controlled Trial
Rehabilitation is crucial for postoperative patients with low back pain (LBP). However, the implementation of traditional clinic-based programs is limited in developing countries, such as China, because of the maldistribution of medical resources. Mobile phone-based programs may be a potential substitute for those who have no access to traditional rehabilitation. The aim of this study was to examine the efficacy of mobile phone-based rehabilitation systems in patients who underwent lumbar spinal surgery. Patients who accepted spinal surgeries were recruited and randomized into 2 groups of rehabilitation treatments: (1) a mobile phone-based eHealth (electronic health) program (EH) or (2) usual care treatment (UC). The primary outcomes were (1) function and pain status assessed by the Oswestry Disability Index (ODI) and (2) the visual analog scale (VAS). Secondary outcomes were (1) general mental health and (2) quality of life (Likert scales, EuroQol-5 Dimension health questionnaire, and 36-item Short-Form Health Survey). All the patients were assessed preoperatively and then at 3, 6, 12, and 24 months postoperatively. A total of 168 of the 863 eligible patients were included and randomized in this study. Our analysis showed that the improvement of primary outcomes in the EH group was superior to the UC group at 24 months postoperatively (ODI mean 7.02, SD 3.10, P<.05; VAS mean 7.59, SD 3.42, P<.05). No significant difference of primary outcomes was found at other time points. A subgroup analysis showed that the improvements of the primary outcomes were more significant in those who completed 6 or more training sessions each week throughout the trial (the highest compliance group) compared with the UC group at 6 months (ODI mean 17.94, SD 5.24, P<.05; VAS mean 19.56, SD 5.27, P<.05), 12 months (ODI mean 13.39, SD 5.32, P<.05; VAS mean 14.35, SD 5.23, P<.05), and 24 months (ODI mean 18.80, SD 5.22, P<.05; VAS mean 21.56, SD 5.28, P<.05). This research demonstrated that a mobile phone-based telerehabilitation system is effective in self-managed rehabilitation for postoperative patients with LBP. The effectiveness of eHealth was more evident in participants with higher compliance. Future research should focus on improving patients' compliance. Chinese Clinical Trial Registry ChiCTR-TRC-13003314; http://www.chictr.org.cn/showproj.aspx?proj=6245 (Archived by WebCite at http://www.webcitation.org/766RAIDNc).
Lumboperitoneal shunt surgery for idiopathic normal pressure hydrocephalus (SINPHONI-2): an open-label randomised trial
Lumboperitoneal shunt surgery has the potential to alleviate symptoms of normal pressure hydrocephalus but the benefits of such surgery have not been tested in a randomised trial. The aim of this trial was to determine the safety and efficacy of the lumboperitoneal shunt surgery for this disorder. For the open-label randomised SINPHONI-2 trial, eligible participants (60–85 years of age) with idiopathic normal pressure hydrocephalus, with ventriculomegaly, and tightness of the high-convexity and medial subarachnoid spaces on MRI, were recruited from 20 neurological and neurosurgical centres in Japan. Enrolled participants were randomly assigned in a 1:1 ratio according to a random code generated by the trial statistician, with a permuted block design (using a block size of 4 or 6) within each centre, to receive lumboperitoneal shunt surgery within 1 month after randomisation, or to surgery postponed for 3 months. Patients and assessors were not masked to treatment assignment. The primary endpoint was favourable outcome, defined as an improvement of one point or more on the modified Rankin scale (mRS) at 3 months after randomisation, analysed by intention to treat, and the main secondary endpoint was the same outcome 12 months after surgery, analysed per protocol. This trial is registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), number UMIN000002730. Between March 1, 2010, and Oct 19, 2011, 93 patients with idiopathic normal pressure hydrocephalus were enrolled and randomly assigned to the immediate treatment group (n=49) or the postponed treatment group (n=44). More patients in the immediate treatment group than in the postponed treatment group had an improvement of one point or more on the mRS at 3 months: 32 (65%) of 49 in the immediate group vs 2 (5%) of 44 in the postponed group (difference 61% [95% CI 42–68]; p<0·0001). The number of patients who had an improvement of one point or more on the mRS at 12 months after surgery was similar between the two groups: 30 (67%) of 45 patients in the immediate group vs 22 (58%) of 38 in the postponed group (difference 9% [95% CI −14 to 31]; p=0·496). The proportions of patients with serious adverse events did not differ significantly between the groups during the 3 months post-randomisation (7 [15%] of 46 in the immediate group vs 1 [2%] of 42 in the postponed group; p=0·060). During the 12 months after surgery, 19 (22%) of 87 patients had serious adverse events, the most common of which was cerebral infarction (six patients [7%]). Our results suggest that lumboperitoneal shunt surgery might be beneficial for patients with idiopathic normal pressure hydrocephalus and, if these findings are confirmed in larger studies, could be a first-line treatment option for this disease. Johnson & Johnson and Nihon Medi-Physics.
Effects of a Manual Treatment on Lumbar Microcirculation and Tissue Stiffness Following Submaximal Eccentric Trunk Extensor Exercise: A Randomized Controlled Trial
Recent studies have shown that the extramuscular connective tissue (ECT) is thickened and stiffened in delayed onset muscle soreness (DOMS). However, contrarily to the normal population, severe DOMS is rare in athletes or highly trained individuals. The present randomized, controlled trial therefore aimed to investigate pain as well as microcirculation and stiffness of the ECT and the erector spinae muscle following submaximal eccentric trunk extension exercise not causing DOMS. The effect of manual treatment by a therapist (myofascial release; MFR) on these parameters was to be studied. Trained healthy participants (n = 21; 31.3 ± 9.6 years; > 4 h exercise per week) performed submaximal eccentric exercise of the trunk extensors. One group was manually treated (n = 11), while the other group (n = 10) received placebo treatment with sham laser therapy. Stiffness of the ECT and the erector spinae muscle (shear wave elastography), microcirculation (white light and laser Doppler spectroscopy), palpation pain (100 mm visual analogue scale, VAS) and pressure pain threshold (indentometry, PPT) were assessed before (t0), 24 h (t24) and 48 h (t48) after conditions. Erector spinae muscle stiffness increased after eccentric exercise from t0 to t24 (0.875 m/s) and from t0 to t48 (0.869 m/s). After MFR, erector spinae muscle stiffness decreased in contrast to placebo treatment at t24 (-0.66 m/s), while ECT stiffness remained unchanged. Oxygen saturation increased (17-20.93%) and relative haemoglobin decreased (-9.1 - -12.76 AU) after eccentric exercise and MFR differed from placebo treatment at t48 (-3.71 AU). PPT differed after MFR from placebo treatment at t48 (20.69 N/mm), while VAS remained unchanged. Multiple linear regression showed that ECT stiffness and group membership predicted erector spinae muscle stiffness. MFR could have a positive effect on pain, microcirculation and muscle stiffness after submaximal eccentric exercise, suggesting better recovery, which needs to be confirmed by future work.
Effects of combining sensory-motor exercises with transcranial direct current stimulation on cortical processing and clinical symptoms in patients with lumbosacral radiculopathy: An exploratory randomized controlled trial
Chronic low back pain (CLBP) is linked to reduced excitability in the primary motor (M1) and sensory (S1) cortices. Combining sensory-motor exercises with transcranial direct current stimulation (tDCS) to boost M1 and S1 excitability may improve treatment outcomes. This combined approach aligns with the neurophysiological mechanisms underlying CLBP and may target the neuroplastic changes induced by low back pain. This study aimed to assess whether enhancing M1 and S1 excitability via tDCS, alongside sensory-motor exercises, offers additional benefits for CLBP patients. Participants were randomly assigned to receive either real or sham tDCS alongside sensory-motor exercises. Outcome measures included pain intensity, disability level, motor control ability, amplitudes of N80 and N150, and the amplitude of motor-evoked potential (MEP) and active motor threshold (AMT) for the multifidus (MF) and transversus abdominis/internal oblique (TrA/IO) muscles. A linear mixed-effects model (LMM) analyzed group, time, and interaction effects, while Spearman's correlation assessed relationships between neurophysiological and clinical outcomes. The results showed significant reductions in pain intensity and disability levels (P < 0.001) and improved motor control (P < 0.001) in both groups. Both groups also exhibited increase in MF MEP amplitude (P = 0.042) and N150 amplitude (P = 0.028). The tDCS group demonstrated a significant decrease in AMT of MF and TrA/IO muscles (P < 0.05) and an increase in N80 amplitude (P = 0.027), with no significant changes in the control group. Additionally, the tDCS group had significantly lower AMT for the TrA/IO muscle in the post-test compared to the sham group (P = 0.001). Increased N150 amplitude was correlated with improved motor control. The findings showed that sensory-motor exercises combined with either tDCS or sham tDCS effectively reduced pain intensity, decreased disability, and improved lumbar motor control in lumbosacral radiculopathy patients. No significant differences were observed between groups, indicating no added clinical benefit from tDCS over exercises alone. However, both groups demonstrated increased N150 and MF MEP amplitudes, suggesting enhanced cortical excitability in motor and sensory regions. While clinical outcomes were similar, neurophysiological data indicate that sensory-motor exercises play a central role in boosting cortical excitability, with tDCS further amplifying this effect, as evidenced by a significant AMT reduction in MF and TrA/IO muscles and an increase in N80 amplitude.
Acute Effects of Percussive Massage Therapy on Thoracolumbar Fascia Thickness and Ultrasound Echo Intensity in Healthy Male Individuals: A Randomized Controlled Trial
Percussive massage therapy (PT) has been widely used by therapists and the fitness population to treat myofascial-related conditions. However, there is no evidence to confirm the effects of PT on the fascia. This study aimed to investigate the effects of PT on thoracolumbar fascia (TLF) morphology and other related outcomes. Methods: Sixty-six healthy males participated and were randomly allocated into a percussive massage group (PT group) and a control group. The PT group received 15 min of back percussion massage, while the control group rested prone lying in the same environment for 15 min. Thoracolumbar fascia (TLF) thickness and echo intensity, perceived stiffness, lumbar flexibility, and skin temperature were measured in both groups before and immediately after the intervention. Result: TLF thickness and lumbar flexibility did not change when compared in the two groups. However, the echo intensity (left side, difference −3.36, 95% CI −5.1 to −1.6; right side, difference −4.39, 95% CI −6.1 to −2.7) and perceived stiffness (difference, −1.18, 95% CI −1.84 to −0.52) in the TLF region were significantly lower in the PT group than in the control group and were accompanied by increased skin temperature (difference 0.29, 95% CI 0.11 to 0.48). Conclusion: We suggest that a 15 min PT with 30 Hz on the back region could reduce TLF echo intensity and perceived stiffness and increase skin temperature in healthy men individual.
Posterior concave reconstruction with cage in the surgical treatment of complex lumbar deformity caused by lumbosacral hemivertebrae
Purpose To identify the clinical and radiological outcomes in the coronal and sagittal planes after treatment of congenital complex lumbosacral hemivertebrae (LSHV) with or without posterior concave reconstruction. Methods We retrospectively reviewed a consecutive series of patients with congenital LSHV deformities treated by posterior-only hemivertebra resection. The minimum follow-up was 2 years. The patients were divided into a concave-cage group and a non-cage group. The radiographic and clinical results were compared between the two groups. Results Forty patients were categorized into the cage group ( n  = 14) and non-cage group ( n  = 26). At the end of the propensity score matching analysis, 14 patients from the cage group were matched to 14 patients in the non-cage group. The lumbosacral curve and thoracolumbar/lumbar curve improved significantly in both groups at the final postoperative follow-up ( P  < 0.001), and the lumbosacral curve at the final follow-up was remarkably lower in the cage than non-cage group. The correction rates of the lumbosacral curve and thoracolumbar/lumbar curve were significantly higher in the cage than non-cage group. The lower lumbar lordosis improved significantly in both groups at the final postoperative follow-up ( P  < 0.05), and the lower lumbar lordosis at the final follow-up and its correction were remarkably higher in the cage than non-cage group (both P  < 0.05). Conclusions Posterior column reconstruction with insertion of a concave cage may achieve a higher correction rate of large lower lumbar lordosis and lumbosacral coronal deformity, attain better sagittal balance, and have fewer complications related to implant failure than posterior-only hemivertebra resection in patients with congenital LSHV.
A multi-level rapid prototyping drill guide template reduces the perforation risk of pedicle screw placement in the lumbar and sacral spine
Introduction The method of free-hand pedicle screw placement is generally safe although it carries potential risks. For this reason, several highly accurate computer-assisted systems were developed and are currently on the market. However, these devices have certain disadvantages. We have developed a method of pedicle screw placement in the lumbar and sacral region using a multi-level drill guide template, created with the rapid prototyping technology and have validated it in a clinical study. The aim of the study was to manufacture and evaluate the accuracy of a multi-level drill guide template for lumbar and first sacral pedicle screw placement and to compare it with the free-hand technique under fluoroscopy supervision. Materials and methods In 2011 and 2012, a randomized clinical trial was performed on 20 patients. 54 screws were implanted in the trial group using templates and 54 in the control group using the fluoroscopy-supervised free-hand technique. Furthermore, applicability for the first sacral level was tested. Preoperative CT-scans were taken and templates were designed using the selective laser sintering method. Postoperative evaluation and statistical analysis of pedicle violation, displacement, screw length and deviation were performed for both groups. Results The incidence of cortex perforation was significantly reduced in the template group; likewise, the deviation and displacement level of screws in the sagittal plane. In both groups there was no significantly important difference in deviation and displacement level in the transversal plane as not in pedicle screw length. The results for the first sacral level resembled the main investigated group. Conclusions The method significantly lowers the incidence of cortex perforation and is therefore potentially applicable in clinical practice, especially in some selected cases. The applied method, however, carries a potential for errors during manufacturing and practical usage and therefore still requires further improvements.
The effectiveness of two different exercise approaches in adolescent idiopathic scoliosis: A single-blind, randomized-controlled trial
The purpose of this study was to compare the efficacy of two different types of exercise methods in patients with adolescent idiopathic scoliosis. In total, 28 subjects with adolescent idiopathic scoliosis with a mild curve magnitude (10°-26°) were randomly divided into two groups: the Schroth group (n = 14) and the core group (n = 14). The patients in the Schroth group were treated with supervised Schroth exercises, and the patients in the core group were treated with supervised core stabilization exercises; both groups performed the exercises for three days per week for a total of 10 weeks, and both were given additional traditional exercises to perform. Assessment included Cobb angle (Radiography), trunk rotation (Adam's test), cosmetic trunk deformity (Walter Reed Visual Assessment Scale), spinal mobility (Spinal Mouse), peripheral muscle strength (Biodex System 4-Pro), and quality of life (Scoliosis Research Society-22 questionnaire). It was found that patients in the Schroth group showed greater improvement in Cobb angles, thoracic trunk rotation angle, cosmetic trunk deformity, spinal mobility, and quality of life than those in the core group (p<0.05), except for in lumbar trunk rotation angle. Peripheral muscle strength improvement was greater in the core group than in the Schroth group (p<0.05). Schroth exercises are more effective than core stabilization exercises in the correction of scoliosis and related problems in mild adolescent idiopathic scoliosis, and core stabilization exercises are more effective than Schroth exercises in the improvement of peripheral muscle strength. NCT04421157.
Tubular discectomy versus conventional microdiscectomy for the treatment of lumbar disc herniation: long-term results of a randomised controlled trial
BackgroundThe reference surgical procedure for the treatment of lumbar disc herniation is open microdiscectomy. Minimal invasive discectomy with tubular retractors is hypothesised to cause less tissue damage and result in lower blood loss, less postoperative pain and faster recovery. We previously reported our 1 and 2-year results, and found no better outcomes of tubular discectomy compared with open microdiscectomy. Until now, no studies on tubular discectomy have reported results with more than 2 years of follow-up. Studies with long-term follow-up are required to determine if clinical outcomes are sustained and to assess specific long-term outcomes such as reoperation rate and iatrogenic low back pain due to impaired spinal integrity. The aim of this study is to evaluate the 5-year results of tubular discectomy compared with conventional microdiscectomy.MethodsThe study was designed as a double-blind randomised controlled trial. 325 patients with a symptomatic lumbar disc herniation were randomly allocated to tubular discectomy (166 patients) or conventional microdiscectomy (159 patients). Repeated standardised follow-up measurements were performed at 2, 4, 6, 8, 12, 26, 38, 52, 78, 104, 156, 208 and 260 weeks after randomisation. Main outcomes are the Roland-Morris Disability Questionnaire for Sciatica (RDQ), Visual Analogue Scale for leg pain and low back pain, self-perceived recovery and reoperation incidence.ResultsThere was no clinically significant difference between tubular discectomy and conventional microdiscectomy regarding the main clinical outcomes at any time point during the 5 years of follow-up. RDQ scores at 5 years were 4.3 (95% CI 3.3 to 5.2) in the tubular discectomy group and 3.4 (95% CI 2.4 to 4.5) in the conventional microdiscectomy group. The mean difference of 0.9 (95% CI −0.6 to 2.2) was not significant. Mean differences for leg pain and back pain were 0.2 (95% CI −5.5 to 6.0) and 0.4 (95% CI −5.9 to 6.7), respectively. 77% of patients allocated to conventional discectomy reported complete or near-complete recovery of symptoms compared with 74% of patients allocated to tubular discectomy (p=0.79). The reoperation rate was 18% in the tubular discectomy group and 13% in the conventional discectomy group (p=0.29).ConclusionsLong-term functional and clinical outcome did not differ between patients allocated to tubular discectomy and conventional microdiscectomy. Primary and secondary outcome measures did not support the hypothesised advantages of tubular discectomy over conventional microdiscectomy.Trial registration numberISRCTN51857546.
Biomechanical comparison of multilevel lateral interbody fusion with and without supplementary instrumentation: a three-dimensional finite element study
Background Lateral lumbar interbody fusion (LLIF) is a popular, minimally invasive technique that is used to address challenging multilevel degenerative spinal diseases. It remains controversial whether supplemental instrumentation should be added for multilevel LLIF. In this study, we compared the kinematic stability afforded by stand-alone lateral cages with those supplemented by bilateral pedicle screws and rods (PSR), unilateral PSR, or lateral plate (LP) fixation using a finite-element (FE) model of a multi-level LLIF construct with simulated osteoporosis. Additionally, to evaluate the prospect of cage subsidence, the stress change characteristics were surveyed at cage-endplate interfaces. Methods A nonlinear 3-dimensional FE model of the lumbar spine (L2 to sacrum) was used. After validation, four patterns of instrumented 3-level LLIF (L2-L5) were constructed for this analysis: (a) 3 stand-alone lateral cages (SLC), (b) 3 lateral cages with lateral plate and two screws (parallel to endplate) fixated separately (LPC), (c) 3 lateral cages with bilateral pedicle screw and rod fixation (LC + BPSR), and (d) 3 lateral cages with unilateral pedicle and rod fixation (LC + UPSR). The segmental and overall range of motion (ROM) of each implanted condition were investigated and compared with the intact model. The peak von Mises stresses upon each (superior) endplate and the stress distribution were used for analysis. Results BPSR provided the maximum reduction of ROM among the configurations at every plane of motion (66.7–90.9% of intact spine). UPSR also provided significant segmental ROM reduction (45.0–88.3%). SLC provided a minimal restriction of ROM (10.0–75.1%), and LPC was found to be less stable than both posterior fixation (23.9–86.2%) constructs. The construct with stand-alone lateral cages generated greater endplate stresses than did any of the other multilevel LLIF models. For the L3, L4 and L5 endplates, peak endplate stresses caused by the SLC construct exceeded the BPSR group by 52.7, 63.8, and 54.2% in flexion, 22.3, 40.1, and 31.4% in extension, 170.2, 175.1, and 134.0% in lateral bending, and 90.7, 45.5, and 30.0% in axial rotation, respectively. The stresses tended to be more concentrated at the periphery of the endplates. Conclusions SLC and LPC provided inadequate ROM restriction for the multilevel LLIF constructs, whereas lateral cages with BPSR or UPSR fixation provided favorable biomechanical stability. Moreover, SLC generated significantly higher endplate stress compared with supplemental instrumentation, which may have increased the risk of cage subsidence. Further biomechanical and clinical studies are required to validate our FEA findings.