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CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis: a randomised controlled trial protocol.

ABSTRACT: Idiopathic scoliosis is a three-dimensional structural deformity of the spine that occurs in children and adolescents. Recent reviews on bracing and exercise treatment have provided some evidence for effect of these interventions. The purpose of this study is to improve the evidence base regarding the effectiveness of conservative treatments for preventing curve progression in idiopathic scoliosis.Previously untreated girls and boys with idiopathic scoliosis, 9 to 17 years of age with at least one year of remaining growth and a curve Cobb angle of 25-40 degrees will be included. A total of 135 participants will be randomly allocated in groups of 45 patients each to receive one of the three interventions.All three groups will receive a physical activity prescription according to the World Health Organisation recommendations. One group will additionally wear a hyper-corrective night-time brace. One group will additionally perform postural scoliosis-specific exercises.Participation in the study will last until the curve has progressed, or until cessation of skeletal growth. OUTCOME variables will be measured every 6 months. The primary outcome variable, failure of treatment, is defined as progression of the Cobb angle more than 6 degrees, compared to the primary x-ray, seen on two consecutive spinal standing x-rays taken with 6 months interval. Secondary outcome measures include the SRS-22r and EQ5D-Y quality of life questionnaires, the International Physical Activity Questionnaire (IPAQ) short form, and Cobb angle at end of the study.This trial will evaluate which of the tested conservative treatment approaches that is the most effective for patients with adolescent idiopathic scoliosis.NCT01761305.

SUBMITTER: Abbott A

PROVIDER: S-EPMC3844437 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis: a randomised controlled trial protocol.

Abbott Allan A Möller Hans H Gerdhem Paul P

BMC musculoskeletal disorders 20130905

<h4>Background</h4>Idiopathic scoliosis is a three-dimensional structural deformity of the spine that occurs in children and adolescents. Recent reviews on bracing and exercise treatment have provided some evidence for effect of these interventions. The purpose of this study is to improve the evidence base regarding the effectiveness of conservative treatments for preventing curve progression in idiopathic scoliosis.<h4>Methods/design</h4><h4>Patients</h4>Previously untreated girls and boys with ...[more]

PMID: 24007599

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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.

Project description:Adolescents with idiopathic scoliosis (AIS) often receive conservative treatments aiming to prevent progression of the spinal deformity during puberty. This study aimed to explore patient adherence and secondary outcomes during the first 6 months in an ongoing randomised controlled trial of three treatment interventions. Interventions consisted of physical activity combined with either hypercorrective Boston brace night shift (NB), scoliosis-specific exercise (SSE), or physical activity alone (PA). Measures at baseline and 6 months included angle of trunk rotation (ATR), Cobb angle, International Physical Activity Questionnaire short form (IPAQ-SF), pictorial Spinal Appearance Questionnaire (pSAQ), Scoliosis Research Society (SRS-22r), EuroQol 5-Dimensions Youth (EQ-5D-Y) and Visual Analogue Scale (EQ-VAS). Patient adherence, motivation, and capability in performing the intervention were reported at 6 months. The study included 135 patients (111 females) with AIS and >1-year estimated remaining growth, mean age 12.7 (1.4) years, and mean Cobb angle 31 (±5.3). At 6 months, the proportion of patients in the groups reporting high to very high adherence ranged between 72 and 95%, while motivation ranged between 65 and 92%, with the highest proportion seen in the NB group (p = 0.014, p= 0.002). IPAQ-SF displayed significant between group main effects regarding moderate activity (F = 5.7; p = 0.004; ηp2 = 0.10), with a medium-sized increase favouring the SSE group compared to NB. Walking showed significant between group main effects, as did metabolic equivalent (MET-min/week), with medium (F = 6.8, p = 0.002; ηp2 = 0.11, and large (F = 8.3, p = < 0.001, ηp2 = 0.14) increases, respectively, for the SSE and PA groups compared to NB. From baseline to 6 months, ATR showed significant between group medium-sized main effects (F = 1.2, p = 0.019, ηp2 = 0.007) favouring the NB group compared to PA, but not reaching a clinically relevant level. In conclusion, patients reported high adherence and motivation to treatment, especially in the NB group. Patients in the SSE and PA groups increased their physical activity levels without other clinically relevant differences between groups in other clinical measures or patient-reported outcomes. The results suggest that the prescribed treatments are viable first-step options during the first 6 months.

Project description:BackgroundSpinal manipulative therapy is commonly used in the treatment of adolescent idiopathic scoliosis. Some therapists also rely on physiotherapeutic scoliosis-specific exercise (PSSE). Combining these two modalities seems reasonable, but the effectiveness of this combination has never been rigorously tested. Here, a protocol for a pilot study is proposed to determine the feasibility of conducting a larger randomized trial. The pilot study was designed to test the hypothesis that spinal manipulative therapy followed by PSSE is more effective than PSSE alone in improving the Cobb angle, sensorimotor integration, the angle of trunk rotation (ATR), body symmetry, and quality of life.MethodsThe protocol describes a randomized controlled pilot trial with 40 subjects divided into study and control groups. Both groups will receive 8 weeks of PSSE, but the study group will also receive spinal manipulative therapy during the first 2 weeks before PSSE. The primary outcome will be an estimate of the feasibility of conducting a full-scale experiment. The influencing factors will be the time to complete enrollment, the recruitment rate, subject retention, and adherence to the treatment allocations. The secondary outcomes that will be used to assess the efficacy of treatment will include the Cobb angle, somatosensory evoked potentials, ATR, three-dimensional postural parameters, and scores on the 22-item Scoliosis Research Society outcomes questionnaire. The Cobb angle will be measured at baseline and at the end of 8 weeks of training. The somatosensory evoked potentials will be measured at baseline and at the end of 2 weeks of training. The ATR, three-dimensional postural parameters, and scores on the 22-item Scoliosis Research Society outcomes questionnaire will be measured at baseline and at 2 weeks, 4 weeks, and 8 weeks of treatment.DiscussionThis study will inform the design of a future full-scale trial. The outcomes will provide preliminary data about the efficacy of the combination of spinal manipulative therapy and exercise in treating scoliosis.Trial registrationProspectively registered at Chinese clinical trial registry, ChiCTR1900027037 . Registered on 29 October 2019. http://www.chictr.org.cn/edit.aspx?pid=44954&htm=4.

Project description:BackgroundIdiopathic scoliosis is the most common spinal deformity in children. Treatment strategies aim to halt progression of the curve. Mild scoliosis is in many cases observed or, in some cases, treated with scoliosis-specific exercises. More severe curves are treated mainly with a brace. The aim of this study is to investigate the effectiveness of scoliosis-specific exercises compared to observation in adolescents with mild idiopathic scoliosis.MethodsSubjects. Previously untreated and skeletally immature children aged 9-15 years of age with idiopathic scoliosis (curve magnitude Cobb 15-24 degrees) will be included. A total of 90 subjects will be included to receive one of two possible interventions. Interventions. Both groups will receive a physical activity prescription according to the World Health Organization recommendations. The intervention group will receive an additional active self-correction treatment strategy for curve correction and will have outpatient sessions once every two weeks for the first three months. They will be prescribed to do the exercises at least three times per week. The intervention will be performed until skeletal maturity or progression of the curve. Outcome. The subjects will participate in the study until curve progression or until skeletal maturity (defined as less than 1 cm growth for six months). The primary outcome variable is failure of treatment, defined as progression of the Cobb angle more than 6 degrees on two consecutive x-rays compared to the baseline x-ray. Secondary outcome measures include patient-reported outcomes, clinical characteristics (i.e. angle of trunk rotation and trunk asymmetry) and number requiring brace treatment. Clinical follow-ups will be performed every six months and radiographs will be taken annually.DiscussionThis study will compare effectiveness of an active self-corrective exercise strategy in mild idiopathic scoliosis with observation in terms of halting curve progression.

Project description:BackgroundCurrently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial.Methods/designThe study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4-15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment pathways, clinical outcomes and safety of non-operative treatment. We have involved children, young people and parents in study design and delivery.DiscussionIn this study we will explore the feasibility of performing a full efficacy RCT comparing non-operative treatment with appendicectomy in children with acute uncomplicated appendicitis. Factors determining success of the present study include recruitment rate, safety of non-operative treatment and adequate interest in the future RCT. Ultimately this feasibility study will form the foundation of the main RCT and reinforce its design.Trial registrationISRCTN15830435 . Registered on 8 February 2017.

Project description:BackgroundIn order to improve post-operative patient's quality-of-life, attention must be paid to the identification of factors that play a role in patient's satisfaction with surgical treatment. Patient satisfaction with the outcomes of scoliosis surgery has not been addressed so comprehensively in Saudi literature, as well as the effect of patient satisfaction on the different domains of the SRS-22 questionnaire and radiographic parameters is yet to be reported locally. The aim of this study is to explore such findings especially in our population.MethodsA retrospective cohort study was conducted at two of the largest centers of spine surgery in the Kingdom of Saudi Arabia. A total of 316 eligible patients were selected via consecutive sampling technique. Data were collected from eligible patients who fit our inclusion criteria, which includes patients with adolescent idiopathic scoliosis aged from 10 to 21 years. Student t test, Pearson's and Spearman's correlation coefficients statistical tests were used.ResultsThere were 283 (89.6%) females and 33 (10.4%) male patients with a mean age of 15.09 (± 2.27 SD) years. All the domains of SRS-22 showed significantly higher scores 2-year postoperatively, when compared with preoperative values (P < 0.001). The change in all SRS-22 domains correlated positively and significantly with the 2-year postoperative satisfaction using Pearson's correlation coefficient (P < 0.05); the total score showed the highest correlation followed by the self-image domain. The major Cobb angle correction percentage correlated significantly (P < 0.05) solely with the change in pain domain.ConclusionSelf-image correlated highly and significantly with patient satisfaction postoperatively. It also had the biggest influence SRS-22 scores postoperatively in conjunction with satisfaction scores. That is an indication of the role it plays in patient satisfaction and quality-of-life postoperatively, which may influence the surgical decision making.

Project description:INTRODUCTION:Deep venous obstruction (DVO) has a great impact on quality of life (QoL) comparable to angina pectoris or chronic pulmonary disease. Post-thrombotic scar formation and May-Thurner syndrome (MTS) are the most common causes of DVO. Conventional treatment of DVO focuses on reducing pain or leg swelling by use of (pain) medication and therapeutic elastic stockings. In the past, a venous bypass was offered in severe post-thrombotic cases, but this procedure showed bad clinical and patency outcomes. With the introduction of percutaneous angioplasty and dedicated venous stents new opportunities were created. Deep venous stenting has been shown to be effective in retrospective case series. However, there is no prior research in which QoL after interventional treatment is compared with QoL after conventional treatment. Currently, there is a debate about the true additional value of interventional treatment. We investigate whether those patients who are treated with stenting experience a change in short form 36 (SF-36) and the Veines-QoL/Sym questionnaires compared with conventionally treated patients. METHODS AND ANALYSIS:This is a randomised trial comparing conservative deep venous management to interventional treatment. A total of 130 patients with post-thrombotic syndrome (PTS) or MTS, eligible for interventional percutaneous treatment, who did not have previous deep venous intervention will be included. Patients will be randomised to conservative treatment or venous stenting and stratified for the PTS or MTS subgroup. Conservative treatment consists of either one or a combination of pain medications, manual lymphatic drainage, compression stockings and regular post-thrombotic anticoagulant therapy.The primary outcome is the QoL change after 12 months compared with baseline QoL. Secondary outcomes are QoL changes at 6 weeks, clinical assessment of DVO, recurrence rate of deep venous thrombosis at 6 weeks and 12 months, and the total amount of working days lost. Intervention-specific outcomes include complications and patency. ETHICS AND DISSEMINATION:The protocol is approved by the Medical Ethics Committee of Academisch ziekenhuis Maastricht/Universiteit Maastricht, The Netherlands (protocol number NLNL55641.068.15 / METC 161008).We aim to publish the results of this study in a peer reviewed journal and present our findings at national or international conferences. TRIAL REGISTRATION NUMBER:The study protocol was registered at www.clinicaltrials.gov (registration number: NCT03026049) on 17 January 2017.

Dataset Information

CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis: a randomised controlled trial protocol.

Publications

CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis: a randomised controlled trial protocol.

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