The effect of a flexible thoracolumbar brace on neuromuscular scoliosis: A prospective observational study.
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ABSTRACT: Abstract
Neuromuscular scoliosis is a common deformity seen in patients with neuromuscular diseases. Although rigid thoracolumbosacral orthosis is the most frequently used brace, it has low compliance rates and can lead to complications including skin ulcers. Thus, alternative methods for treating neuromuscular scoliosis are needed. The purpose of this study is to evaluate the clinical effects of a novel flexible brace to prevent the progression of neuromuscular scoliosis.This study is a prospective observational study. Twenty-three patients with neuromuscular scoliosis were enrolled in the study. Among patients diagnosed with neuromuscular disease, spine radiographs were checked for a neuromuscular scoliosis diagnosis. The participants were treated with a novel flexible brace for 6 months. The control group (n = 46) was selected using propensity score matching method from a clinical data warehouse. The Cobb angle was measured and compared between the study and control groups.In the study group, the average Cobb's angle significantly decreased from 47.22 ± 18.9° to 31.8 ± 20.0 when wearing the flexible brace (P < .001). Thus, the correction rate was 36.9%. The annual progression rate was significantly lower in the study group than in the control group (P < .05).The flexible brace showed a significant correction rate of scoliosis in patients with severe neuromuscular diseases. The flexible brace is an alternative treatment modality for patients with neuromuscular scoliosis. Daily application of the flexible brace during the growing period can reduce the degree of fixed deformity in the long term.
SUBMITTER: Jang J
PROVIDER: S-EPMC8360469 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:[Purpose] Individuals with Parkinson's disease (PD) experience postural dysfunction, which can contribute to pain and an increased risk for falls. One method with limited research for addressing postural dysfunction is bracing. The objective of this pilot study was to establish the immediate impact of a novel thoracolumbar brace on postural alignment in individuals with PD. [Participants and Methods] This study utilized a single-participant randomized A-B design. Participants were included if they had a diagnosis of PD were 50-80 years of age, reported difficulty with posture, but were able to ambulate within their home and the community. Ten kinematic assessments of posture were completed in each phase. The primary outcome measure was postural alignment at the neck, trunk, and hip/knee. An analysis of postural stability and experience wearing the brace was also completed. [Results] Nine out of ten participants demonstrated at least one statistically significant change in a posture variable, but postural stability was variable across participants. [Conclusion] This pilot study demonstrated that the brace functioned as expected bringing postural alignment into a more neutral or extended position at the trunk and hip/knee. Further research on the long-term effect of the brace needs to be completed to determine its clinical value.
| S-EPMC7008014 | biostudies-literature
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| S-EPMC4349706 | biostudies-literature
Project description:BackgroundThe conservative treatment of adolescent idiopathic scoliosis (AIS) has traditionally been divided into two phases-correction and stabilisation-and casts, even if less used today, can be considered the best standard in the correction phase. Till the present, however, no comparison between cast and brace efficacy has been proposed.MethodsThis is a prospective cohort study with a retrospective control group. The aim was to verify if it is possible to obtain with a specifically developed rigid brace results comparable to a cast. We considered fifty AIS patients who had refused surgery, aged 14.1 +/- 1.5 years, with 46.7 +/- 7.8 degrees Cobb scoliosis. Thirty-two consecutive patients (with no drop-outs) were prospectively followed up with the Sforzesco brace (SBG), and compared against a retrospective group of eighteen patients treated with the Risser cast (RCG). The treatment time (the total correction phase) was 19 +/- 3 months. Out-of-brace x-rays were compared, as well as clinical results.ResultsCompliance and hours of treatment were higher in the RCG while all the other parameters were not different. We observed a reduction of 6 degrees Cobb and an important aesthetic gain in both groups (P<0.05). Three patients (6%) worsened, while 56% improved (36% at least 10 degrees , and 14% 15 degrees or more). The SBG did show results comparable to the RCG, with only minor differences in terms of scoliosis correction. On the contrary, straightening of the spine (decrease of the sagittal physiological curves) was much higher in the RCG but was not clinically significant in the SBG.ConclusionIn the corrective phase of AIS treatment it is possible with a specific rigid brace (Sforzesco - SPoRT concept) to obtain scoliosis correction similar to cast. Due to the human and social costs of casting, and worst sagittal profile results, Sforzesco brace should be the preferred method wherever possible.
| S-EPMC2612643 | biostudies-literature
Project description:IntroductionAdolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine. Brace treatment is effective for eligible patients with AIS and the effectiveness is significantly correlated with the average brace-wear time per day. Three-dimensional (3D) printing technology is a recent advancement that offers unique opportunities for biomedical applications, and customisation of scoliosis braces might lead to greater patient satisfaction and improved compliance. We present here the design of a randomised controlled trial on the clinical effectiveness of 3D-printed braces versus thoracolumbosacral orthoses (TLSO) for patients with AIS.Methods and analysisPatients with AIS (age 10-16 years) with Risser sign 0-II, Cobb angle of main curve of 20°-40°, premenarchal or no more than 1-year postmenarchal (for women), and no history of treatment are eligible, unless they are unable to tolerate the treatment or refuse participation. A total of 88 patients will be randomised into either the 3D group or TLSO group on a 1:1 basis. Participants in the 3D group will choose between a 3D-printed brace and TLSO, according to the Zelen's design of the trial. Primary outcome measures will include the average brace-wear time per day, health-related quality of life and Cobb angle progression of the primary curve. Secondary outcome measures will include immediate in-brace correction of Cobb angle of the primary curve, rate of conversion to surgery and incidence of any adverse events. This study is designed as a single-centre, two-arm, superiority and open-label randomised controlled trial. The sample size is calculated with reference to the preliminary study and based on the sample size calculation formula.Ethics and disseminationThis study was approved by the Peking University Third Hospital Medicine Science Research Ethics Committee (No: 2019-017-02). Results of the trial will be submitted for publication in a peer-reviewed journal and as conference presentations.Trial registration numberChiCTR1900027379, pre-results.
| S-EPMC7703428 | biostudies-literature
Project description:BackgroundBracing concepts in use today for the treatment of scoliosis include symmetric and asymmetric hard braces usually made of polyethylene (PE) and soft braces. A new asymmetric Chêneau style CAD/CAM derivate has been designed to overcome problems the author experienced with other Chêneau CAD/CAM systems over the recent years.Brace descriptionThis CAD/CAM Chêneau derivate has been called Gensingen brace™, a brace available to address all possible curve patterns. Once the patients' trunk is scanned with the help of a whole trunk optical 3D-scan and the patients' data from the clinical measurements are recorded, a model of the brace can be created by (1) modifying the trunk model of the patient 'on screen' to achieve a very individual brace model using the CAD/CAM tools provided or by (2) choosing a brace model from our library and re-size it to the patients' properties 'on screen'.ResultsEnd-result studies have been published on the Chêneau brace as early as 1985. Cohort studies on the Chêneau brace are available as is a prospective controlled study respecting the SRS criteria for bracing studies, demonstrating beneficial outcomes, when compared to the controls using a soft brace. Sufficient in-brace correction effects have been demonstrated to be achievable when the Chêneau principles of correction are used appropriately. As there is a positive correlation between in-brace correction and the final outcome, the Chêneau concept of bracing with sufficient in-brace corrections as published can be regarded as being efficient when applied well. Case reports with high in-brace corrections, as shown within this paper using the Gensingen brace™ promise beneficial outcomes when a good compliance can be achieved.ConclusionsThe use of the Gensingen brace™ leads to sufficient in-brace corrections, when compared to the correction effects achieved with other braces, as described in literature.According to the patients' reports, the Gensingen brace™ is comfortable to wear, when adjusted properly.Further studies are necessary (1) in order to evaluate brace comfort and (2) effectiveness using the SRS inclusion criteria.
| S-EPMC2967515 | biostudies-literature
Project description:BACKGROUND:Selective thoracolumbar/lumbar fusion technique was introduced to treat adolescent idiopathic scoliosis (AIS) patients with major thoracolumbar/lumbar curves. Theoretically, this surgical strategy could also be applied to syringomyelia patients. No previous study has specifically addressed the effectiveness of selective thoracolumbar/lumbar fusion for patients with syringomyelia-associated scoliosis. The aim of the study was to investigate the effectiveness of selective thoracolumbar/lumbar fusion for the surgical treatment of patients with syringomyelia-associated scoliosis. METHODS:From February 2010 to September 2016, 14 syringomyelia-associated patients with major thoracolumbar/lumbar curves were retrospectively reviewed. Besides, 30 Lenke 5C AIS patients were enrolled as a control group. Posterior selective thoracolumbar/lumbar fusion was performed for both groups. Patients' demographic, operative, radiological, and quality of life data were reviewed with follow-up. Intragroup comparisons were performed for each parameter. RESULTS:The two groups were matched by age, gender, curve characteristics, duration of follow-up, and all preoperative radiographic parameters except for thoracic kyphosis. After surgery, the average correction rate of the major thoracolumbar/lumbar curve was 82.2?±?7.8% in the syringomyelia group, which was not significantly different from that of AIS group (82.5?±?10.6%, P?=?0.47). A similar improvement of unfused thoracic curve was observed between the two groups (50.1?±?16.5% vs. 48.5?±?26.9%, P?=?0.29). During the follow-up, the correction effect of scoliosis was well maintained, without aggravation of the original neural symptoms or fresh permanent neurological deficits. Of note, the number of fusion levels was significantly larger in syringomyelia group than that in AIS group (7.6?±?1.4 vs. 6.5?±?1.2, P?<?0.01). The average follow up was 47.6?months (36-81?months). CONCLUSION:Similar to AIS cases, syringomyelia-associated scoliosis can be effectively and safely corrected by selective thoracolumbar/lumbar fusion with satisfactory surgical outcomes. However, the syringomyelia group, on average, required an additional fused segment for treatment as compared to the AIS group (7.6 versus 6.5 in the AIS group).
| S-EPMC7666459 | biostudies-literature
Project description:BackgroundA substantial impediment to progress in trials of new therapies in neuromuscular disorders is the absence of responsive outcome measures that correlate with patient functional deficits and are sensitive to early disease processes. Irrespective of the primary molecular defect, neuromuscular disorder pathological processes include disturbance of intramuscular water distribution followed by intramuscular fat accumulation, both quantifiable by MRI. In pathologically distinct neuromuscular disorders, we aimed to determine the comparative responsiveness of MRI outcome measures over 1 year, the validity of MRI outcome measures by cross-sectional correlation against functionally relevant clinical measures, and the sensitivity of specific MRI indices to early muscle water changes before intramuscular fat accumulation beyond the healthy control range.MethodsWe did a prospective observational cohort study of patients with either Charcot-Marie-Tooth disease 1A or inclusion body myositis who were attending the inherited neuropathy or muscle clinics at the Medical Research Council (MRC) Centre for Neuromuscular Diseases, National Hospital for Neurology and Neurosurgery, London, UK. Genetic confirmation of the chromosome 17p11.2 duplication was required for Charcot-Marie-Tooth disease 1A, and classification as pathologically or clinically definite by MRC criteria was required for inclusion body myositis. Exclusion criteria were concomitant diseases and safety-related MRI contraindications. Healthy age-matched and sex-matched controls were also recruited. Assessments were done at baseline and 1 year. The MRI outcomes-fat fraction, transverse relaxation time (T2), and magnetisation transfer ratio (MTR)-were analysed during the 12-month follow-up, by measuring correlation with functionally relevant clinical measures, and for T2 and MTR, sensitivity in muscles with fat fraction less than the 95th percentile of the control group.FindingsBetween Jan 19, 2010, and July 7, 2011, we recruited 20 patients with Charcot-Marie-Tooth disease 1A, 20 patients with inclusion body myositis, and 29 healthy controls (allocated to one or both of the 20-participant matched-control subgroups). Whole muscle fat fraction increased significantly during the 12-month follow-up at calf level (mean absolute change 1.2%, 95% CI 0.5-1.9, p=0.002) but not thigh level (0.2%, -0.2 to 0.6, p=0.38) in patients with Charcot-Marie-Tooth disease 1A, and at calf level (2.6%, 1.3-4.0, p=0.002) and thigh level (3.3%, 1.8-4.9, p=0.0007) in patients with inclusion body myositis. Fat fraction correlated with the lower limb components of the inclusion body myositis functional rating score (?=-0.64, p=0.002) and the Charcot-Marie-Tooth examination score (?=0.63, p=0.003). Longitudinal T2 and MTR changed consistently with fat fraction but more variably. In muscles with a fat fraction lower than the control group 95th percentile, T2 was increased in patients compared with controls (regression coefficients: inclusion body myositis thigh 4.0 ms [SE 0.5], calf 3.5 ms [0.6]; Charcot-Marie-Tooth 1A thigh 1.0 ms [0.3], calf 2.0 ms [0.3]) and MTR reduced compared with controls (inclusion body myositis thigh -1.5 percentage units [pu; 0.2], calf -1.1 pu [0.2]; Charcot-Marie-Tooth 1A thigh -0.3 pu [0.1], calf -0.7 pu [0.1]).InterpretationMRI outcome measures can monitor intramuscular fat accumulation with high responsiveness, show validity by correlation with conventional functional measures, and detect muscle water changes preceding marked intramuscular fat accumulation. Confirmation of our results in further cohorts with these and other muscle-wasting disorders would suggest that MRI biomarkers might prove valuable in experimental trials.FundingMedical Research Council UK.
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Project description:Intraoperative neuromuscular blockade affects the resting tension between the vocal cords. We assessed the effect of neuromuscular blockade on postoperative sore throat and hoarseness following tracheal intubation in patients undergoing lumbar spinal surgery in the prone position. Altogether, 99 patients were included; 50 patients did not receive neuromuscular blockade, and 49 patients received moderate neuromuscular blockade during the maintenance of anesthesia. Neuromuscular blockade was performed depending on the use of intraoperative neurophysiological monitoring. The number of intubation attempts, time to achieve tracheal intubation, and duration of intubation were recorded accordingly. The incidence and severity of postoperative sore throat and hoarseness was assessed at 1, 6, and 24 h after surgery. The overall cumulative incidence of postoperative sore throat (60% vs. 59%, respectively; P = 1.000) and postoperative hoarseness (68% vs. 61%, respectively; P = 0.532) did not differ between the no neuromuscular blockade and moderate neuromuscular blockade. The incidence and severity of postoperative sore throat and hoarseness was also not different between the moderate and no neuromuscular blockade at each time point after surgery. Nevertheless, the incidences of postoperative sore throat and hoarseness were quite high. Further studies investigating strategies to alleviate them are warranted accordingly.
| S-EPMC7481207 | biostudies-literature
Project description:BACKGROUND:Four factors have been reported to affect brace treatment outcome: (1) growth or curve based risk, (2) the in-brace correction, (3) the brace wear quantity, and (4) the brace wear quality. The quality of brace design affects the in-brace correction and comfort which indirectly affects the brace wear quantity and quality. This paper reported the immediate benefits and results on using ultrasound (US) to aid orthotists to design braces for the treatment of scoliosis. METHODS:Thirty-four AIS subjects participated in this study with 17 (2 males, 15 females) in the control group and 17 (2 males, 15 females) in the intervention (US) group. All participants were prescribed full time TLSO, constructed by either of the 2 orthotists in fabrication of spinal braces. For the control group, the Providence brace design system was adopted to design full time braces. For the intervention group, the custom standing Providence brace design system, plus a medical ultrasound system, a custom pressure measurement system and an in-house software were used to assist brace casting. RESULTS:In the control group, 8 of 17 (47%) subjects needed a total of 11 brace adjustments after initial fabrication requiring a total of 28 in-brace radiographs. Three subjects (18%) required a second adjustment. For the US group, only 1 subject (6%) required adjustment. The total number of in-brace radiographs was 18. The p value of the chi-square for requiring brace adjustment was 0.006 which was a statistically significant difference between the two groups. In the intervention group, the immediate in-brace correction as measured from radiographs was 48?±?17%, and in the control group the first and second in-brace correction was 33?±?19% and 40?±?20%, respectively. The unpaired 2 sided Student's t test of the in-brace correction was significantly different between the US and the first follow-up of the control group (p?=?0.02), but was not significant after the second brace adjustment (p?=?0.22). CONCLUSIONS:The use of the 3D ultrasound system provided a radiation-free method to determine the optimum pressure level and location to assist brace design, resulting in decreased radiation exposure during follow-up brace evaluation, increased the in-brace correction, reduced the patients' visits to both brace adjustment and scoliosis clinics. However, the final outcomes could not be reported yet as some of patients are still under brace treatment. TRIAL REGISTRATION:NCT02996643, retrospectively registered in 16 December 2016.
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