Scalp acupuncture treatment for motor dysfunction in children with cerebral palsy: study protocol for a multicenter randomized controlled Trial [post]

2019 unpublished
Scalp acupuncture has shown a remarkable treatment efficacy on motor dysfunction in children with cerebral palsy, especially when performed on the motor area of Jiao's scalp acupuncture, which is the most widely used treatment. However, previous studies have summarized that the clinical curative effect of acupuncture treatment for children with cerebral palsy remains uncertain. Meanwhile, no randomized controlled trials on scalp acupuncture have been performed. The aim of this study is to
more » ... te the efficacy and safety of scalp acupuncture for motor dysfunction in children with cerebral palsy. Methods/design: This is an assessor and analyst blinded, randomized controlled trial. One hundred cerebral palsy patients with motor dysfunction meeting the inclusion criteria will be allocated by a 1:1 ratio into either an acupuncture treatment group or a control group. Cerebral palsy in the control group will receive conventional rehabilitation treatment, whereas a combination of scalp acupuncture and conventional rehabilitation treatment will be applied to the acupuncture group. Thirty-six treatment sessions will be performed over a 12-week period. The Gross Motor Function Measure and the Fine Motor Function Measure Scale will be assessed as the primary outcome measure. The Pediatric Evaluation of Disability Inventory, and the Cerebral Palsy Quality of Life Questionnaire for Children will be selected as secondary outcome measurements. All assessments will be conducted at baseline, week 4 (treatment 12), week 8 (treatment 24), week 12 (treatment 36), and week 24 (follow-up). Discussion: This is the first trial evaluating the efficacy and safety of scalp acupuncture for motor dysfunction in children with cerebral palsy. The results of this trial are expected to provide relevant evidence demonstrating that scalp acupuncture can be used as an effective rehabilitation treatment method for improving motor dysfunction in children with 4 cerebral palsy. Background Cerebral palsy (CP) is a well-recognized neurodevelopmental disorder beginning in the early childhood and persisting throughout the patient's lifetime. Motor disorders are often accompanied by disturbances of sensation, cognition, communication, perception, behavior, and seizures [1-3]. CP is the most common physical disability in childhood with a prevalence of 1.5 to 3.8 per 1000 live births in Europe, Australia, and the United States [4] [5] [6] . In 2004, the lifetime cost of health care for cerebral palsy in the USA was estimated at $921,000 [7, 8] . In China, an epidemiologic study published in 2016 indicates a prevalence of 2.48 per 1000 children aged 1 to 6 years old based on a survey of 12 cities. According to this estimate, there are about 5 million children with CP among children under 14 years old and about 40,000 new cases will be diagnosed every year based on the estimated number of 16 million newborns per year in China [9] . Due to motor dysfunction in children with CP, the activities of daily living (ADL) and social participation are restricted, which greatly influences the quality of life (QOL) and their ability to adapt to society. In addition, this places a heavy burden on families and society as a whole and becomes a significant public health issue [10] . Western standard conventional treatment is multi-professional rehabilitation in children with CP, which including physical therapy (PT), occupational therapy (OT), and speech therapy (ST) is added in some children [8, 11] . This approach is a complex procedure and multi-disciplinary designed to minimize complications and improve function [10]. In China, CP rehabilitation treatment framework mainly develops the clinical program mode of combining western medicine and traditional Chinese medicine. Acupuncture is used as a complementary and alternative treatment, which has increased worldwide and has become widely applied to CP rehabilitation treatment. Clinical trials have demonstrated Road,
doi:10.21203/rs.2.12483/v1 fatcat:o4ia4fceqfgbjkxnxi3uljskga