Trials · 2014
Acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Wang Yan, Gao Yun-xian, Sun Qi, Bu Qian, Shi Jing, Zhang Ya-ni, Xu Qin, Ji Yan, Tong Min, Jiang Guang-li
Аннотация
BACKGROUND: Myopia is a public health problem worldwide and its incidence increases with age. The use of acupuncture to treat myopia is a common practice in China, however, the use of acupuncture to treat myopia is disputed in other parts of the world. This study aims to determine the safety of acupuncture to treat myopia and its efficacy over six months.
METHODS/DESIGN: A randomized, parallel, single-center, assessor- and statistician-blinded, controlled clinical trial will be performed. A total of 100 teenagers, between seven and 12 years of age, with mild-to-moderate myopia and spherical lenses <-6.00 D and cylindrical lenses <-1.50 D will be selected from the Xinjiang Uygur Autonomous Region Institute of Traditional Chinese Medicine, a grade III level A teaching hospital in Urumqi, Xinjiang, China (Xinjiang Medical University Affiliated Hospital of Traditional Medicine). The subjects will be randomly assigned to two different groups (control and acupuncture groups), each group containing 50 subjects. The subjects in both groups wear single-vision corrective lenses. In the acupuncture group, acupuncture will be performed daily for nine consecutive days on five points (bilateral Cuanzhu, Tongziliao, Sibai, Muchuang, and Hegu), followed by no treatment for one day. Six cycles of treatment will be undertaken continuously for a total of 60 days. Following 60 days of treatment, a follow-up period of six months will be included. The primary outcome will be diopter determination. The secondary outcomes will include distance visual acuity, axial length, lens thickness, ciliary body thickness, and subjective symptoms of the eyes and entire body. The main time points for the evaluation of clinical efficacy will be the first, third, and sixth months after treatment.
DISCUSSION: This study will provide clinical observations of various indices following the use of acupuncture to treat adolescents with mild-to-moderate myopia, as well as information on the safety of acupuncture.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-13003448; registration date: 7 August 2013).
METHODS/DESIGN: A randomized, parallel, single-center, assessor- and statistician-blinded, controlled clinical trial will be performed. A total of 100 teenagers, between seven and 12 years of age, with mild-to-moderate myopia and spherical lenses <-6.00 D and cylindrical lenses <-1.50 D will be selected from the Xinjiang Uygur Autonomous Region Institute of Traditional Chinese Medicine, a grade III level A teaching hospital in Urumqi, Xinjiang, China (Xinjiang Medical University Affiliated Hospital of Traditional Medicine). The subjects will be randomly assigned to two different groups (control and acupuncture groups), each group containing 50 subjects. The subjects in both groups wear single-vision corrective lenses. In the acupuncture group, acupuncture will be performed daily for nine consecutive days on five points (bilateral Cuanzhu, Tongziliao, Sibai, Muchuang, and Hegu), followed by no treatment for one day. Six cycles of treatment will be undertaken continuously for a total of 60 days. Following 60 days of treatment, a follow-up period of six months will be included. The primary outcome will be diopter determination. The secondary outcomes will include distance visual acuity, axial length, lens thickness, ciliary body thickness, and subjective symptoms of the eyes and entire body. The main time points for the evaluation of clinical efficacy will be the first, third, and sixth months after treatment.
DISCUSSION: This study will provide clinical observations of various indices following the use of acupuncture to treat adolescents with mild-to-moderate myopia, as well as information on the safety of acupuncture.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-13003448; registration date: 7 August 2013).