Dynamic Compression Brace for Pectus Carinatum
Condition: Pectus Carinatum
MeSH terms: Pectus Carinatum
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      There is no consensus about exercises, and there is not enough scientific evidence about the
      wear time of orthosis. The existing treatment protocols are non-standardized protocols
      developed by the researchers of previous studies investigating the effectiveness of orthosis.
      Martinez-Ferro et al., the developer of the dynamic compression brace, recommends the daytime
      wear of orthosis for patients with low pressure of correction. They recommend duration of
      clothing to be shorter and the pressure of treatment should be kept lower in patients with
      high pressure of correction. However, every compression brace may not contain dock and
      pressure of treatment cannot be measured. In the present study we aimed to investigate the
      effects of exercises and compression brace in children with PC. Also, safety and feasibility
      of the orthosis will be evaluated. Patients with chondro-gladiolar, symmetrical or
      asymmetric, compressible PC (compression test positive) and with correction pressure ≤10 PSI,
      aged 5-18 years old will be included to study. They will be randomized to three groups using
      closed envelope system. All groups will be given exercises to strengthen the muscles of the
      respiratory muscles of the posture exercises, deep breathing exercises, ribs manipulation and
      mobilization exercises and core exercises for 1 hour a day, five days a week for 3 weeks. The
      first group will use the orthosis for 8 hours during the night and the second group for 23
      hours except for sports activities, exercise and bath. The control group who will receive
      exercise therapy only will be selected from the wait-in list for the orthosis. Pectus
      carinatum protrusion, pressure of correction, anteroposterior and lateral diameter of thorax
      at the most protruded part of deformity, Haller index, Cobb and kyphosis angle, Pectus
      Evaluation Questionnaire will be assessed at before treatment and after treatment, 1 month
      and 3 months and 6 months after treatment.
    

Intervention name(s): Dynamic compression brace; Exercises
Intervention type(s): Other; Other
Intervention description(s): custom-fitted brace adjusts the pressure on the thoracic wall and enables lateral expansion of the thorax; posture exercises, deep breathing exercises, exercises for manipulation and mobilization of ribs, and core exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel group randomized controlled study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; pectus carinatum; orthosis; dynamic compression brace