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. 2024 Jun 12;14(6):e078895.
doi: 10.1136/bmjopen-2023-078895.

Efficacy and safety of transcutaneous electrical acupoint stimulation for the management of primary dysmenorrhoea: protocol for a randomised controlled trial in China

Weiting Liu #  1 , Yanting Ding #  2 , Honggang Xie  3 , Hansheng Liu  4 , Changhao Liang  5
Affiliations

Efficacy and safety of transcutaneous electrical acupoint stimulation for the management of primary dysmenorrhoea: protocol for a randomised controlled trial in China

Weiting Liu et al. BMJ Open. .

Abstract

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.

Keywords: dysmenorrhea; pain management; quality of life.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Schedule of enrolment, interventions and assessments. PI, pulsatility index; RI, resistance index; SAS, Self-rating Anxiety Scale; S/D, ratio of systolic peak and diastolic peak; SDS, Self-rating Depression Scale; SF-12, 12-item Short-Form Health Survey; SF-MPQ, Short-Form McGill Pain Questionnaire; TEAS, transcutaneous electrical acupoint stimulation; VAS, Visual Analogue Scale.
Figure 2
Figure 2
Trial design flow chart. TEAS, transcutaneous electrical acupoint stimulation.
See this image and copyright information in PMC

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