BMJ open · 2024
Efficacy and safety of transcutaneous electrical acupoint stimulation for the management of primary dysmenorrhoea: protocol for a randomised controlled trial in China.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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.
Liu Weiting, Ding Yanting, Xie Honggang, Liu Hansheng, Liang Changhao
Аннотация
INTRODUCTION: Primary dysmenorrhoea (PD) is a common menstrual concern with significant physical and psychosocial impacts. The effectiveness and safety of transcutaneous electrical acupoint stimulation (TEAS) in alleviating PD symptoms remain uncertain due to insufficient evidence. This single-centre, parallel, randomised controlled study intends to evaluate the efficacy and safety of TEAS for PD management.
METHODS AND ANALYSIS: 60 participants aged 18-40 years diagnosed with moderate to severe PD will be recruited from Tai'an Hospital of Traditional Chinese Medicine (TCM) and randomly assigned to either a TEAS group or a TEAS-sham group (1:1). The TEAS group will undergo 12 sessions of TEAS treatment over two menstrual cycles, with 30 min per session, three sessions weekly. Participants in the TEAS-sham group will receive TEAS stimulation using identical devices and protocols but without current output. The primary outcome is the Visual Analogue Scale (VAS) for pain assessment. Secondary outcomes are Short-Form McGill Pain Questionnaire, total effective rate, uterine artery haemodynamics, prostaglandin and β-endorphin level, mental well-being and quality of life. Adverse events and their potential reasons and the use of analgesics will also be recorded.
ETHICS AND DISSEMINATION: This study was approved by the Medical Ethics Committee of Tai'an Hospital of TCM. Written informed consent will be obtained from each participant. The results will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: ChiCTR2300071686.
METHODS AND ANALYSIS: 60 participants aged 18-40 years diagnosed with moderate to severe PD will be recruited from Tai'an Hospital of Traditional Chinese Medicine (TCM) and randomly assigned to either a TEAS group or a TEAS-sham group (1:1). The TEAS group will undergo 12 sessions of TEAS treatment over two menstrual cycles, with 30 min per session, three sessions weekly. Participants in the TEAS-sham group will receive TEAS stimulation using identical devices and protocols but without current output. The primary outcome is the Visual Analogue Scale (VAS) for pain assessment. Secondary outcomes are Short-Form McGill Pain Questionnaire, total effective rate, uterine artery haemodynamics, prostaglandin and β-endorphin level, mental well-being and quality of life. Adverse events and their potential reasons and the use of analgesics will also be recorded.
ETHICS AND DISSEMINATION: This study was approved by the Medical Ethics Committee of Tai'an Hospital of TCM. Written informed consent will be obtained from each participant. The results will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: ChiCTR2300071686.