The classification of scoliosis braces developed by SOSORT with SRS, ISPO, and POSNA and approved by ESPRM.

PURPOSE: Studies have shown that bracing is an effective treatment for patients with idiopathic scoliosis. According to the current classification, almost all braces fall in the thoracolumbosacral orthosis (TLSO) category. Consequently, the generalization of scientific results is either impossible or misleading. This study aims to produce a classification of the brace types. METHODS: Four scientific societies (SOSORT, SRS, ISPO, and POSNA) invited all their members to be part of the study. Six level 1 experts developed the initial classifications. At a consensus meeting with 26 other experts and societies' officials, thematic analysis and general discussion allowed to define the classification (minimum 80% agreement). The classification was applied to the braces published in the literature and officially approved by the 4 scientific societies and by ESPRM. RESULTS: The classification is based on the following classificatory items: anatomy (CTLSO, TLSO, LSO), rigidity (very rigid, rigid, elastic), primary corrective plane (frontal, sagittal, transverse, frontal & sagittal, frontal & transverse, sagittal & transverse, three-dimensional), construction-valves (monocot, bivalve, multisegmented), construction-closure (dorsal, lateral, ventral), and primary action (bending, detorsion, elongation, movement, push-up, three points). The experts developed a definition for each item and were able to classify the 15 published braces into nine groups. CONCLUSION: The classification is based on the best current expertise (the lowest level of evidence). Experts recognize that this is the first edition and will change with future understanding and research. The broad application of this classification could have value for brace research, education, clinical practice, and growth in this field.

Estimation of plane of maximum curvature for the patients with adolescent idiopathic scoliosis via a purpose-design computational method.

PURPOSE: The coronal Cobb angle is commonly used for assessing the adolescent idiopathic scoliosis (AIS); however, it may underestimate the severity of AIS while the plane of maximum curvature (PMC) could be a promising descriptor for three-dimensional assessment of AIS. This study aimed to develop a computational method (CM) for estimating the PMC based on the coronal and sagittal images of the spine, and to verify the results with computed tomography (CT). METHODS: Twenty-eight thoracic and 24 lumbar curves from 30 subjects with AIS were analysed. For the CM, PMC was estimated via identifying the two corner points at the superior endplate of upper-end vertebra and the inferior endplate of lower-end vertebra in the coronal and sagittal CT images separately (eight corner points in total). For the CT, PMC was determined through rotating the spine images axially until the maximum Cobb angle was found. Intraclass correlation coefficient (ICC), Bland-Altman method and linear regression analysis were used for the statistical analyses. RESULTS: The high ICC values (intra- > 0.91; inter- > 0.84) suggested very good intra- and inter-rater reliability of the CM in PMC estimation. The high ICC values (> 0.91) and assessment of Bland-Altman method demonstrated a good agreement between the PMC acquired using the CM and CT. The generated linear regression equations (R2 > 0.69) could allow to estimate the PMC (originally measured through the CT) via the CM. CONCLUSION: The developed computational method could estimate reliable and valid PMC for the patients with AIS, and become feasible for three-dimensional assessment of AIS. LEVEL OF EVIDENCE: III.

Reliability and validity of lateral curvature assessments using clinical ultrasound for the patients with scoliosis: a systematic review.

PURPOSE: Clinical ultrasound is radiation-free, low cost and user friendly, which makes it probable in assessment of scoliosis. Numerous studies have been conducted about the feasibility of using clinical ultrasound to assess scoliosis; thus, an inclusive review of the literature would be beneficial for researchers, clinicians and patients. This study aimed to systematically review the reliability and validity of coronal curvature assessments obtained from different clinical ultrasound imaging methods. METHODS: A comprehensive search of 6 databases and Google Scholar search engine was performed for retrieving articles assessing reliability and/or validity of spinal curvature measurements obtained from clinical ultrasound. Two reviewers assessed the methodological quality of selected articles independently using criteria appraisal instrument. The results were analysed and synthesized qualitatively using level of evidence method. RESULTS: Fourteen articles were included. Thirteen articles investigated both the reliability and validity, of which nine were of high quality; and one article evaluated only the reliability and was of high quality. Totally five ultrasound methods were evaluated. Very high reliability (intra-class correlation coefficient = 0.80-1.00) but limited levels of evidence were found for the majority of the studied ultrasound methods. Almost all the methods showed good to excellent validity (correlation coefficient = 0.76-1.00) but limited to moderate levels of evidence. CONCLUSION: A high level of evidence was found in support of the reliability and validity of the COL (centre of lamina) ultrasound method. Further reliability and validity studies should be conducted to strengthen the level of evidence for those ultrasound methods with moderate, limited or conflicting level of evidence. These slides can be retrieved under Electronic Supplementary Material.

[Three-dimensional Ultrasound Imaging of Coronal Curvature and Vertebral Rotation Changes from Supine to Standing in Patients with Adolescent Idiopathic Scoliosis].

OBJECTIVE: To investigate the gravitational effect on coronal curvature and vertebral rotation using 3-D ultrasound in patients with adolescent idiopathic scoliosis (AIS). METHODS: Sixteen female patients with AIS were recruited and examined using a 3-D ultrasound unit incorporated with SonixGPS system (Ultrasonix Medical Corporation, Canada). Ultrasound scanning was performed continuously along the coronal plane from C7 to S1, with a standing and a supine position, respectively. Coronal curvature and vertebral rotation were measured using the center of laminae (COL) method. Multivariate linear regression models were established to determine factors associated with changes of lateral curvature and vertebral rotation in different posture positions. The correlations of measurements between standing and supine were tested using Pearson correlation analyses. RESULTS: Changes of coronal curvature and vertebral rotation from a supine to a standing posture were within 1.9°-11.7° and 0.0°-5.9°, respectively. The changes increased with the severity of AIS. The 3-D ultrasound measurements of lateral curvature and vertebral rotation were highly correlated. CONCLUSION: 3-D ultrasound can reveal changes of coronal curvature and vertebral rotation from a supine to a standing posture in patients with AIS, which increase with the severity of AIS. Further studies in large samples are warranted.

[Three-dimensional Ultrasound Assessment on Apical Vertebral Rotation in Patients with Adolescent Idiopathic Scoliosis:Reliability and Validity Analyses].

OBJECTIVE: To assess reliability and validity of the three-dimensional (3-D) ultrasound measurement of apical vertebral rotation in patients with adolescent idiopathic scoliosis (AIS). METHODS: Sixteen female AIS patients were recruited. Ultrasound examinations were performed using a 3-D ultrasound unit with a SonixGPS system,which were compared with magnetic resonance imaging (MRI) examinations conducted on the same day. Two raters performed 3-D ultrasound scanning in supine position on angle measurements for vertebral rotation in the transverse plane three times,respectively. The center of laminae (COL) method was used to measure apical vertebral rotation in the 3-D ultrasound image,compared with the Aaro-Dahlborn results of MRI. Reliability of the 3-D ultrasound measurements was assessed using intra-class correlation coefficients (ICC),mean absolute deviation (MAD),standard deviation (SD) and standard error of measurement (SEM). Validity of the 3-D ultrasound measurements was assessed using paired Student t-tests,Bland-Altman statistics and Pearson correlation coefficients. The level of significance was set as 0.05. RESULTS: 3-D ultrasound had high intra- and inter-rater reliabilities (ICC [2,k]>0.9,P<0.05) for assessing vertebral rotation. There was no significant difference between the Aaro-Dahlborn results in MRI and the COL Results in 3-D ultrasound (P>0.05). High consistencies (Bland-Altman) and correlations (Pearson) were demonstrated between the two methods. CONCLUSION: Radiation-free 3-D ultrasound is a reliable and valid method for measuring apical vertebral rotation in the transverse plane of patients with AIS.

A prospective randomized controlled study on the treatment outcome of SpineCor brace versus rigid brace for adolescent idiopathic scoliosis with follow-up according to the SRS standardized criteria.

PURPOSE: SpineCor is a relatively innovative brace for non-operative treatment of adolescent idiopathic scoliosis (AIS). However, the effectiveness of SpineCor still remains controversial. The objective of the current study was to compare the treatment outcomes of SpineCor brace with that of rigid brace following the standardized Scoliosis Research Society (SRS) criteria on AIS brace study. METHODS: Females subjects with AIS and aged 10-14 were randomly allocated into two groups undergoing treatment of SpineCor (S Group, n = 20) or rigid brace (R Group, n = 18). During SpineCor treatment, patients who had curve progression of >5° would be required to switch to rigid brace treatment. The effectiveness of the two brace treatments was assessed using the SRS standardized criteria. RESULTS: Before skeletal maturity, 7 (35.0%) patients in the S Group and 1 (5.6%) patient in the R Group had curve progression >5° (P = 0.026). At skeletal maturity, 5 of the 7 (71.4%) patients who failed with SpineCor bracing showed control from further progression by changing to rigid bracing. At the latest follow-up with a mean duration of 45.1 months after skeletally maturity, 29.4% of patients who were successfully treated by rigid brace showed further curve progression beyond skeletal maturity, versus 38.5% of patients in the SpineCor group (P > 0.05). For both groups, the primary curves were slightly improved at the time of brace weaning, but additionally increased at the latest follow-up, with a rate of 1.5° per year for post-maturity progression. CONCLUSIONS: Curve progression rate was found to be significantly higher in the SpineCor group when compared with the rigid brace group. Changing to rigid bracing could control further curve progression for majority of patients who previously failed with SpineCor bracing. For both SpineCor and rigid brace treatments, 30-40% of patients who were originally successfully treated by bracing would exhibit further curve progression beyond skeletal maturity. The post-maturity progression rate was found to be 1.5° per year in the current study, which was relatively greater than those reported before.

The effect of stretching exercises before orthotic treatment on the immediate in-orthosis correction of the patients with adolescent idiopathic scoliosis: A pilot study.

BACKGROUND: Stretching exercise is generally used for improving flexibility. However, its application to promote orthotic treatment for patients with adolescent idiopathic scoliosis (AIS) remains unknown. OBJECTIVE: This study was to explore the effect of pre-orthosis stretching exercises on spinal flexibility and initial in-orthosis correction for the patients with AIS. STUDY DESIGN: A pilot-controlled study. METHODS: An experimental group (EG) of 13 subjects (10 girls and 3 boys) with AIS allocating to self-stretching exercises and a control group (CG) of 19 AIS subjects (14 girls and 5 boys) with no stretching before orthosis fitting were recruited. The spinal flexibility of the EG was evaluated with an ultrasound imaging system and physical measurements. The initial in-orthosis correction rates between the 2 groups were compared with the independent t test, and the correlation analysis between the spinal flexibility measured from ultrasound images and physical measurement was performed with the Pearson correlation test. RESULTS: The initial Cobb angle of EG and CG were 25.70° ± 7.30° and 28.09° ± 5.58°, respectively. No significant difference was observed between the initial in-orthosis Cobb angle of EG (11.13° ± 6.80°) and CG (15.65° ± 9.10°) (p = 0.06). However, the spinal flexibility after stretching exercises was improved (p < 0.001), and the spinal flexibility changes measured with ultrasound and physical forward-bending method were significantly correlated (r = 0.57, p < 0.05). CONCLUSION: Stretching exercises before orthotic treatment could improve the spinal flexibility but did not cause a better in-orthosis correction. A study with a larger sample size and longer follow-up period should be conducted to investigate the long-term effect of stretching exercises.

Effectiveness of Orthotic Treatment on Clinical Outcomes of the Patients with Adolescent Idiopathic Scoliosis Under Different Wearing Compliance Levels: A Systematic Review.

BACKGROUND: Wearing spinal orthosis for 16 to 23 hours a day during the teenage years could be challenging and stressful for patients with adolescent idiopathic scoliosis (AIS). The investigation of clinical outcomes under various orthosis-wearing compliances can provide helpful insight into orthotic treatment dosage. This systematic review aims to investigate actual orthosis-wearing compliance and evaluate the effectiveness of orthotic treatment in controlling scoliotic curvature and preventing surgery for patients with AIS under various levels of orthosis-wearing compliance. METHODS: A literature search of 7 electronic databases, namely PubMed, MEDLINE, Cochrane Library, Scopus, CINAHL Complete, Web of Science, and Embase, was conducted on May 19, 2023. Participant characteristics, orthotic treatment protocols, compliance information, outcome measures, and key findings were extracted. The Newcastle-Ottawa Scales were used to evaluate the quality of included cohort and case-control studies. RESULTS: This study systematically reviewed 17 of 1,799 identified studies, including 1,981 subjects. The actual compliance was inconsistent and ranged from 7.0 to 18.8 hours daily. The proportion of compliant subjects in each study varied from 16.0% to 78.6% due to the heterogeneity of calculation period, measurement methods, and orthosis prescription time. Thirteen studies were investigated to determine the effectiveness of orthotic treatment in controlling curve deformity under different compliance groups, and 2 studies compared the compliance under different treatment outcomes. The rate of curve progression, defined as surpassing the measurement error threshold of 5° or 6° after orthotic treatment, varied from 1.8% to 91.7% across the studies. Ten studies defined the treatment failure, surgery, or surgery indication as Cobb angle progressing to a certain degree (e.g., 40°, 45°, or 50°) and reported failure/surgery/surgery indication rates ranging from 0.0% to 91.7% among different compliance level groups. CONCLUSION: This review found that the actual compliance with orthotic treatment was generally lower than the prescribed wearing time and exhibited wide variation among different studies. The electronic compliance monitors show promise in regular orthotic treatment practice. More importantly, the group with higher and consistent compliance has significantly less curve progression and lower surgery or failure rate than the group with lower and inconsistent compliance. Further studies are proposed to investigate the minimal orthosis-wearing compliance in patients with AIS treated with different types of orthoses. LEVEL OF EVIDENCE: Level III, Systematic Review. See Instructions for Authors for a complete description of levels of evidence.

Associations between spinal flexibility and bracing outcomes in adolescent idiopathic scoliosis: a literature review.

OBJECTIVES: To identify the existing assessment methods used to measure the spinal flexibility of adolescents with idiopathic scoliosis before bracing and to evaluate the predictive effect of spinal flexibility on bracing outcomes. METHODS: A broad literature search was performed in the PubMed, Web of Science, EMBASE, CINAHL, Scopus, and Cochrane Library databases to obtain relevant information about spinal flexibility and bracing outcomes. All literature was retrieved by October 14, 2023. The inclusion and exclusion criteria were meticulously determined. The quality of each included study and the level of evidence were evaluated by the Quality in Prognosis Studies (QUIPS) method and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system, respectively. RESULTS: After screening 1863 articles retrieved from databases, a total of 14 studies with 2261 subjects were eligible for the final analysis in this review. Overall, nine methods of flexibility assessment were identified, including supine radiographs, supine lateral bending radiographs, lateral bending radiographs but without clear positions, hanging radiographs, fulcrum bending physical method, and ultrasound imaging in the positions of supine, prone, sitting with side bending and prone with side bending. In addition, five studies demonstrated that flexibility had a strong correlation with in-brace correction, and eleven studies illustrated that spinal flexibility was a predictive factor of the bracing outcomes of initial in-brace Cobb angle, initial in-brace correction rate, curve progression, and curve regression. The results of GRADE demonstrated a moderate-evidence rating for the predictive value of spinal flexibility. CONCLUSION: Supine radiography was the most prevalent method for measuring spinal flexibility at the pre-brace stage. Spinal flexibility was strongly correlated with the in-brace Cobb angle or correction rate, and moderate evidence supported that spinal flexibility could predict bracing outcomes.

A feasibility study of application of purpose-design frame and 3-D clinical ultrasound in assessment and design of spinal orthoses for adolescent idiopathic scoliosis.

BACKGROUND: The immediate in-orthosis correction of adolescent idiopathic scoliosis (AIS) is a useful prognostic parameter for the long-term orthotic treatment outcome. The 3-D clinical ultrasound technique is considered a noninvasive alternative to assess scoliotic deformities that could be applied in the orthotic treatment of AIS. OBJECTIVE: This study aimed to investigate the feasibility of a purpose-design assessment frame in estimating biomechanical effects of the controlling pads of a spinal orthosis under the guidance of the ultrasound system. METHODS: Twenty-six subjects with AIS were recruited and arranged to position inside the assessment frame, and controlling pads were applied strategically while the scoliotic deformities were assessed by clinical ultrasound to obtain at least 30% curvature correction, and the body shape was then captured using a computer-aided design and computer-aided manufacture system, and spinal orthoses were subsequently fabricated. The preorthosis and immediate in-orthosis coronal and sagittal X-rays were used for comparison. RESULTS: X-ray assessments showed that the mean coronal Cobb angle and lumbar lordosis of the subjects from the preorthosis to immediate in-orthosis visits decreased significantly ( p < 0.05) from 29.6° to 16.6°, and from 47.2° to 35.3°, respectively. CONCLUSIONS: This feasibility study showed that the proposed method would have a good potential to improve orthotic treatment outcome in a documented approach that should be considered for implementation into routine clinical practice aiming to reduce the chance of deformity deterioration leading to surgical intervention. However, a controlled group study is required to compare the results.

Going below and beyond the surface: Microneedle structure, materials, drugs, fabrication, and applications for wound healing and tissue regeneration.

Microneedle, as a novel drug delivery system, has attracted widespread attention due to its non-invasiveness, painless and simple administration, controllable drug delivery, and diverse cargo loading capacity. Although microneedles are initially designed to penetrate stratum corneum of skin for transdermal drug delivery, they, recently, have been used to promote wound healing and regeneration of diverse tissues and organs and the results are promising. Despite there are reviews about microneedles, few of them focus on wound healing and tissue regeneration. Here, we review the recent advances of microneedles in this field. We first give an overview of microneedle system in terms of its potential cargos (e.g., small molecules, macromolecules, nucleic acids, nanoparticles, extracellular vesicle, cells), structural designs (e.g., multidrug structures, adhesive structures), material selection, and drug release mechanisms. Then we briefly summarize different microneedle fabrication methods, including their advantages and limitations. We finally summarize the recent progress of microneedle-assisted wound healing and tissue regeneration (e.g., skin, cardiac, bone, tendon, ocular, vascular, oral, hair, spinal cord, and uterine tissues). We expect that our article would serve as a guideline for readers to design their microneedle systems according to different applications, including material selection, drug selection, and structure design, for achieving better healing and regeneration efficacy.

Fostering integration among students with different backgrounds using an orthotic community service program.

BACKGROUND: In this globalization era, institutions are developing strategies including international service-learning pedagogies to integrate global perspectives and dimensions into the learning and teaching processes to develop students' capacity in intercultural competence. OBJECTIVE: This study aimed to assess the students' intercultural learning outcome through provision of orthotic community service to the less-privileged children. METHODS: A Hong Kong-based university collaborated with 2 American universities to conduct an orthotic community service program for the children with cerebral palsy in mainland China. In the process of service delivery, the students with different backgrounds worked closely and students' professional knowledge, intercultural understanding, and communication skills were evaluated. A mixed-method approach was adopted to investigate on how this international program could facilitate meaningful interactions in clinical practices. Preprogram and postprogram surveys and focus group interviews were conducted. Statistical analyses were performed on the quantitative data, while interview data were analyzed thematically. RESULTS: A comparison of preprogram and postprogram surveys showed that the students perceived this community service program important for enhancement of their capabilities to communicate with people from other cultures (n = 39, p < 0.05). It also showed an increase in local students' willingness to work with people from other cultures. Some themes related to intercultural competences were identified from the interview: "intercultural awareness, understanding, and communication" as well as openness to work/socialize with people from other cultures." CONCLUSIONS: This study demonstrated that an international community service program could initiate positive changes in students' intercultural communication capability and interest to work with culturally different people.

Quality of Life in Lower-Limb Amputees 10 Years After the 2008 Sichuan Earthquake: A Cross-Sectional Study.

OBJECTIVE: The aim of this study was to investigate the long-term outcome of quality of life (QOL) in the lower-limb amputees 10 years after the 2008 Sichuan earthquake. METHODS: In the cross-sectional study, 66 lower-limb amputees were recruited. The prosthetics-related QOL was assessed using the Prosthetic Evaluation Questionnaire (PEQ) in terms of the scales of utility, appearance, sounds, residual limb health, perceived response, frustration, social burden, ambulation, and well-being. The score of each PEQ subscale was calculated and compared among the cohorts with different demographic characteristics. RESULTS: The PEQ scores showed that the scales of sounds, residual limb health, and frustration were still low in the lower-limb amputees 10 years after the 2008 Sichuan earthquake. The comparison of PEQ scales among cohorts with different demographic characteristics indicated that the potential demographic risk factors, namely, age, marital status, educational level, living independence, and comorbidity, were associated with prosthesis-related QOL. CONCLUSIONS: The prosthesis-related QOL of the lower-limb amputees 10 years after the 2008 Sichuan earthquake has been partly documented in this study. The potential demographic risk factors associated with QOL of amputees were also identified. These findings could enhance the understanding of prosthesis-related QOL of lower-limb amputees sustained in an earthquake and facilitate the optimization of post-disaster rehabilitation strategies.

Pain issues in the victims with lower-limb amputation: 10 years after the 2008 Sichuan earthquake.

PURPOSE: To study the prevalence, intensity, and bothersomeness of amputation-related pain and further to identify the potential risk factors in the victims with lower-limb amputation 10 years after the 2008 Sichuan earthquake. METHODS: In the cross-sectional study, 66 victims with lower-limb amputation were recruited. The Prostheses Evaluation Questionnaire was used to document the prevalence, intensity, and bothersomeness of amputation-related pain. The bivariate relationships between amputation-related pain and each of demographic characteristics were analyzed. RESULTS: Majority of the enrolled lower-limb amputees (90.9%) reported to have one or more types of amputation-related pain. The intensity and bothersomeness of amputation-related pain were considered as severe in nearly 40% of these post-earthquake victims. The potential demographic risk factors associated with the prevalence, intensity, and bothersomeness of amputation-related pain were identified, including the age, lower level of education, marital status, employment, and comorbidity. CONCLUSIONS: The pain coming from phantom limb, residual limb, non-amputated limb, and back was found persistent in the lower-limb amputees 10 years after the 2008 Sichuan earthquake. The findings of this study could provide useful reference for optimization of post-disaster rehabilitation strategies to alleviate chronic pain in the victims following lower-limb amputation.Implications for RehabilitationThe pain coming from phantom limb, residual limb, non-amputated limb, and back was found persistent in the victims with lower-limb amputation 10 years after the 2008 Sichuan earthquake.Continuous post-earthquake assessment and management of amputation-related pain should be taken into consideration for the victims with lower-limb amputation.The comorbidity should be effectively and efficiently controlled for the victims with lower-limb amputation due to its association with the intensity and bothersomeness of amputation-related pain.

Compliance study of hip protector users for prevention of fragility fracture: A pilot randomized trial.

BACKGROUND: Hip protectors have been widely used for hip fracture prevention in the elderly, but its efficacy remains controversial. Users' compliance to hip protector is an important factor for its efficacy. However, the assessment of users' compliance tended to be subjective and unreliable in the past. OBJECTIVES: To quantify the elderly's compliance to hip protectors and investigate the effect of different underpant designs on the elderly's compliance. STUDY DESIGN: A pilot randomized trial. METHODS: Thirty-one participants were recruited and provided with hip protectors in which compliance monitors were installed and delivered with three pairs of either the conventional underpants or the purpose-design underpants randomly. Participants were encouraged to use the hip protectors with the assigned underpants for whole day. After 4 weeks, compliance data were downloaded from the compliance monitors. Participants were also asked to fill a survey form for acceptance analysis. The Spearman correlation coefficient and the Wilcoxon signed-rank test/2 independent samples t test/Mann-Whitney U test were used for the corresponding statistical analyses. RESULTS: Thirty-one participants were recruited initially. Eighteen participants were excluded from instrumented compliance analysis because of limited or no data collection. The data of the resting 13 participants (six in the conventional underpants group and seven in purpose-design underpants group) were analyzed and showed an average instrumented compliance of 77.5% which was lower than the average self-reporting compliance (83.3%) of all the available 23 participants (eight of 31 became wheelchair-bounded). Participants' compliance was positively correlated with their acceptance to the hip protectors and significantly higher in the purpose-design underpants group than in the conventional underpants group ( P < 0.05). CONCLUSIONS: This pilot study demonstrated a feasible protocol for compliance quantification of the elderly to the hip protectors, the importance to have an objective compliance measure to assess users' actual compliance, and purpose-design underpants could improve the users' compliance. Future studies with long-term observation and large sample size deserve further proof of the current findings.

Effect of different undergarment designs on the compliance and acceptance of the patients with adolescent idiopathic scoliosis under orthotic treatment.

BACKGROUND: Patient's acceptance and compliance to spinal orthosis could influence the outcome of orthotic treatment in adolescent idiopathic scoliosis. Two innovative undergarments (thin and thick designs) were designed to improve the patient's orthosis wearing experience and acceptance. OBJECTIVE: This study aimed to evaluate the effects of patients' self-provided undergarment and 2 newly designed undergarments with respect to the orthosis wearing compliance and quality of life (QoL) measures. METHODS: A prospective randomized-controlled study was conducted to compare the effect of three types of undergarments. Thirty-eight subjects with adolescent idiopathic scoliosis were randomly assigned to one of the three groups: self-provided, thin-design, or thick-design undergarment. Wearing compliance logbook, Scoliosis Research Society questionnaire, and Brace Questionnaire were used to document the orthosis wearing period and quantify the health-related and orthosis-related QoL measures. Kruskal-Wallis one-way analysis of variance (ANOVA) and Friedman two-way ANOVA by ranks tests were conducted for intergroup and intragroup comparisons, respectively. RESULTS: The compliance and QoL domains of the subjects in the thin-design undergarment group were significantly higher than those of the other two undergarment groups (P < .05). The intragroup compliance and QoL scores varied significantly in the 4 visits throughout the study period (P < .05). CONCLUSIONS: It was observed that an adaptation period toward the prescribed spinal orthosis is required to help patients gradually achieve a more stable acceptance. The thin-design undergarment was ranked higher than the other two tested undergarments in compliance and QoL measures.

A Randomized Controlled Trial to Evaluate the Clinical Effectiveness of 3D-Printed Orthosis in the Management of Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Prospective randomized controlled trial. OBJECTIVE: To compare clinical effectiveness and quality of life (QoL) of the 3D-printed orthosis (3O) and conventional orthosis (CO) for adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Using 3D printing technology to design and fabricate orthoses to manage AIS aiming to improve in-orthosis correction and patients' compliance that are considered essential factors of effective treatment. Clinical evaluation was conducted to study the effectiveness of this innovative method. METHODS: Thirty females with AIS who met the criteria (age 10-14, Cobb 20-40°, Risser sign 0-2, ≤12 months after menarche) were recruited. Subjects were randomly allocated to the 3O group (n = 15, age 12.4, Cobb 31.8°) and CO group (n = 15, age 12.0, Cobb 29.3°). All patients were prescribed for full-time wearing (23 hours/d) and follow-up every 4 to 6 months until bone maturity. Compliance was monitored by thermosensors, while QoL was assessed using three validated questionnaires. RESULTS: Comparable immediate in-orthosis correction was observed between 3O (-11.6°, P < 0.001) and CO groups (-12.9°, P < 0.001). In the QoL study via SRS-22r, the 3O group got worse results after 3 months in aspects of function, self-image, and mental health (-0.5, -0.6, -0.7, P < 0.05) while the CO group had worse results in aspects of self-image and mental health (-0.3, -0.3, P < 0.05). No significant difference was found in QoL assessments between groups. After 2 years of follow-up, 22 patients were analyzed with 4 dropouts in each group. Comparable angle reduction was observed in both groups (3O: -2.2°, P = 0.364; CO: -3.5°, P = 0.193). There was one subject (9.1%) in the 3O group while two subjects (18.2%) in the CO group had curve progression >5°. Daily wearing hours were 1.9 hours longer in the 3O group than the CO group (17.1 vs. 15.2 hours, P = 0.934). CONCLUSION: The 3O group could provide comparable clinical effects as compared with the CO group while patients with 3O showed similar compliance and QoL compared to those with CO.Level of Evidence: 1.

Biomechanical Effects of Thoracolumbosacral Orthosis Design Features on 3D Correction in Adolescent Idiopathic Scoliosis: A Comprehensive Multicenter Study.

STUDY DESIGN: Multicenter numerical study. OBJECTIVE: To biomechanically analyze and compare various passive correction features of braces, designed by several centers with diverse practices, for three-dimensional (3D) correction of adolescent idiopathic scoliosis. SUMMARY OF BACKGROUND DATA: A wide variety of brace designs exist, but their biomechanical effectiveness is not clearly understood. Many studies have reported brace treatment correction potential with various degrees of control, making the objective comparison of correction mechanisms difficult. A Finite Element Model simulating the immediate in-brace corrective effects has been developed and allows to comprehensively assess the biomechanics of different brace designs. METHODS: Expert clinical teams (one orthotist and one orthopedist) from six centers in five countries participated in the study. For six scoliosis cases with different curve types respecting SRS criteria, the teams designed two braces according to their treatment protocol. Finite Element Model simulations were performed to compute immediate in-brace 3D correction and skin-to-brace pressures. All braces were randomized and labeled according to 21 design features derived from Society on Scoliosis Orthopaedic and Rehabilitation Treatment proposed descriptors, including positioning of pressure points, orientation of push vectors, and sagittal design. Simulated in brace 3D corrections were compared for each design feature class using ANOVAs and linear regressions (significance P ≤ 0.05). RESULTS: Seventy-two braces were tested, with significant variety in the design approaches. Pressure points at the apical vertebra level corrected the main thoracic curve better than more caudal locations. Braces with ventral support flattened the lumbar lordosis. Lateral and ventral skin-to-brace pressures were correlated with changes in thoracolumbar/lumbar Cobb and lumbar lordosis (r =- 0.53, r = - 0.54). Upper straps positioned above T10 corrected the main thoracic Cobb better than those placed lower. CONCLUSIONS: The corrective features of various scoliosis braces were objectively compared in a systematic approach with minimal biases and variability in test parameters, providing a better biomechanical understanding of individual passive mechanisms' contribution to 3D correction.

Nonoperative management of adolescent idiopathic scoliosis (AIS) using braces.

This review presents the state of the art according to the current evidence on nonoperative treatment for adolescent idiopathic scoliosis, focusing on bracing. The definition of braces for the treatment of adolescent idiopathic scoliosis and a short history are provided. The analysis includes biomechanics, types, existing classifications, indications for treatment, time of brace wear and weaning, adherence, three-dimensional modeling, use of ultrasound imaging for bracing, management of treatment, issue of immediate in-brace correction, and documentation of the outcomes usually assessed for brace treatment, including the quality-of-life issues. According to the current evidence, there are two randomized control trials in favor of bracing. There are insufficient data on the superiority of one brace over another, although it is possible to classify and grade braces for efficacy from nonrigid to rigid and very rigid. Nevertheless, there is consensus on patients' management on the need for teamwork focusing on adherence to treatment, acceptability, and family and patient involvement.