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临床试验/NCT03559244
NCT03559244已完成不适用

Investigating the Effects of Exercises in Addition to Dynamic Compression Brace in Patients With Pectus Carinatum: a Single Blinded Randomized Controlled Trial

Marmara University2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2018年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
Pectus carinatum protrusion

研究概览

简要总结

Pectus carinatum (PC) is a deformity of the anterior chest wall which is a common pediatric condition, characterized by an idiopathic overgrowth of the costal cartilages resulting in protrusion of the sternum. Chest pain or discomfort, especially when lying in prone position, increased respiratory effort during exercise, scoliosis, impaired shoulders and kyphotic position are some of the physical signs and symptoms. Unlike pectus excavatum, PC is rarely associated with significant cardiopulmonary involvement except in severe cases. Pectus carinatum is not just a simple aesthetical problem. The effect of patient's self-esteem, body image and confidence can be variable and lead to significant deterioration in mental health. It can be responsible of physical signs and symptoms and also has significant psychological impact. Deformity and its psychological impact tend to worsen during pubertal rapid phases of growth and even during adult life. The management of pectus deformities used to include surgical techniques, however, recently compression brace which is a dynamic orthosis which is custom-fitted, rigid aluminum brace that is adjustable to any thoracic shape is widely applied instead of surgery. Pressure applied to the patient, in the most protruding area of the chest, needed to accomplish a proper shape of the thorax, the pressure of correction can be measured via a pressure measuring device in pounds per square inches (PSI). Treatment choices of surgery or bracing is determined according to pressure of correction and type of deformity. Surgical correction is indicated if the presence of chondro-manubrial type PC and pressure of correction > 10 PSI. Chest pain or discomfort, especially when lying in prone position, increased respiratory effort during exercise, scoliosis, impaired shoulders and kyphotic position are some of the physical signs and symptoms. Despite the fact that patients with PC have impaired posture, exercise intolerance and increased scoliosis occurrence, there is no consensus on the exercise program for patients with PC. Also, there is not enough scientific evidence about the wear time of orthosis. The aim of this study is to investigate the effects of exercises and compression brace in children with PC.

详细描述

Pectus carinatum (PC) is a deformity of the anterior chest wall which is a common pediatric condition, characterized by an idiopathic overgrowth of the costal cartilages resulting in protrusion of the sternum. There are two subtypes of PC: the chondro-gladiolar variant, which is the most common type, and presents with protrusion of the sternal body, and the chondro-manubrial variant, showing protrusion of the component of the sternum (manubrium). PC usually involves the lower sternal costal cartilages, pushing the sternum forwards and can be symmetrical (bilateral) or often asymmetrical (unilateral) with the right for some reason being more obviously affected. PC may occur as a solitary abnormality or in association with other genetic disorders or syndromes (eg, trisomy 18, Marfan syndrome, homocystinuria, Morquio syndrome, and Ehlers-Danlos syndrome). Of the musculoskeletal abnormalities, scoliosis is most frequently associated with PC.

Chest pain or discomfort, especially when lying in prone position, increased respiratory effort during exercise, scoliosis, impaired shoulders and kyphotic position are some of the physical signs and symptoms. Unlike pectus excavatum, PC is rarely associated with significant cardiopulmonary involvement except in severe cases. Pectus carinatum is not just a simple aesthetical problem. It can be responsible of physical signs and symptoms and also has significant psychological impact. Deformity and its psychological impact tend to worsen during pubertal rapid phases of growth and even during adult life. It has been demonstrated that patients with PC are at risk for a disturbed body image and reduced quality of life and many patients refer feelings of discomfort, shame, shyness, anxiety, and even depression.

The classical management of pectus deformities, both carinatum and excavatum, has been primarily surgical. Modification of the Ravitch technique involves resection of the deformed costal cartilages along with sternal osteotomy. Because the results of this technique resulted in worse cosmetic results, a new less invasive procedure, the Nuss procedure was developed. Nuss procedure includes remodeling of the chest wall cartilage with an internal support bar. These techniques have demonstrated the plasticity of the chest wall and led clinicians to hypothesize that carinatum defects would also remodel in response to chronic pressure, leading to a cosmetically superior, nonoperative technique: compression brace. Compression brace is a dynamic orthosis which is custom-fitted, rigid aluminum brace that is adjustable to any thoracic shape. Complications of brace use include uncommon (4.6%), mild and easy to resolve: back pain, hematoma and skin ulceration. Pressure of correction is the pressure applied to the patient, in the most protruding area of the chest, needed to accomplish a proper shape of the thorax. It is an indirect parameter of the chest wall's flexibility. It can be measured with a pressure measuring device in pounds per square inches (PSI). Some special designed braces contain a part in which pressure measuring device can be docked. This enables measuring of pressure of treatment. Pressure of treatment can be different from pressure of correction since skin breakdown occurs with corrections at high pressure.

In the Calgary protocol, wearing brace 23 hours a day during the correction phase until the development of the axial skeleton is completed and afterwards 8 hours of wear is recommended in the continuation phase.Martinez-Ferro et al developed pressure measuring device and special designed braces contain a part in which pressure measuring device can be docked. They suggested that patients with pressure of correction <10 should be braced. De Beer et al. also recommended the surgical treatment in the presence of chondro-manubrial type PC and pressure of correction > 10 PSI. However, recommendations are based on prospective or retrospective cohort studies other than randomized controlled trials which corresponds to low level of evidence.

Despite the fact that patients with PC have impaired posture, exercise intolerance and increased scoliosis occurrence, there is no consensus on the exercise program for patients with PC. Postural impairment aggravates psychological burden caused by disease itself. Patients with pectus carinatum may get benefit from exercises to improve posture. Also, disease itself or compression brace use may result in abdominal flare and increased lateral diameter of chest wall as an unwanted effect. Strengthening of abdominal muscles may prevent from abdominal flare. Strengthening of chest wall muscles, strengthening the pectoralis and sacrospinalis muscles as well as expanding the chest through deep breathing, strengthening core muscles including abdominal muscles, increasing flexibility of muscles, manipulation and mobilization of costae may lead improvements in the management of PC.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

outcome assessor blinded to participants' allocated group

入排标准

年龄范围
5 Years 至 20 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients with pectus carinatum
  • Symmetric or asymmetric pectus carinatum
  • Compression test positive
  • Pressure of correction <10 PSI

排除标准

  • History of orthosis use
  • Chondro-manubrial pectus carinatum
  • Concomitant severe scoliosis (Cobb angle>20)
  • Having history of chronic disease
  • History of surgery for scoliosis or pectus carinatum

研究组 & 干预措施

Dynamic compression brace 8 hours

Experimental

Children with pectus carinatum who will wear dynamic compression brace 8 hours a day plus exercises for three weeks

干预措施: Dynamic compression brace (Other)

Dynamic compression brace 8 hours

Experimental

Children with pectus carinatum who will wear dynamic compression brace 8 hours a day plus exercises for three weeks

干预措施: Exercises (Other)

Dynamic compression brace 23 hours

Experimental

Children with pectus carinatum who will wear dynamic compression brace 23 hours (except for bathing and sports activities) a day plus exercises for three weeks

干预措施: Dynamic compression brace (Other)

Dynamic compression brace 23 hours

Experimental

Children with pectus carinatum who will wear dynamic compression brace 23 hours (except for bathing and sports activities) a day plus exercises for three weeks

干预措施: Exercises (Other)

Only exercises

Active Comparator

The children who are in wait in list for dynamic compression brace will receive only posture exercises, deep breathing exercises, exercises for manipulation and mobilization of ribs, and core exercises for three weeks

干预措施: Exercises (Other)

结局指标

主要结局

Pectus carinatum protrusion

时间窗: 3 weeks

distance from the point of maximum protrusion to the estimated normal level of chest wall

次要结局

  • T1 (external measurement of chest wall at the upper age of manubrium)(3 weeks)
  • T3 (external measurement of chest wall at the most protruded point from the chest wall)(3 weeks)
  • Cobb angle(3 weeks)
  • Pressure of correction(3 weeks)
  • Thorax lateral diameter measurement(3 weeks)
  • T2 (external measurement of chest wall at Angulus Ludovici)(3 weeks)
  • Haller index(3 weeks)
  • Pectus Evaluation Questionnaire parent form(3 weeks)
  • Thorax AP diameter measurement(3 weeks)
  • Kyphotic angle(3 weeks)
  • Pectus Evaluation Questionnaire patient form(3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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