The BMEA study: the impact of meridian balanced method electroacupuncture on women with chronic pelvic pain--a three-arm randomised controlled pilot study using a mixed-methods approach

摘要

Introduction: Chronic pelvic pain (CPP) affects 3–4%udof women worldwide. Proven treatments for CPP areudlimited and unsatisfactory. The meridian balanceudmethod (BM) electroacupuncture (EA) treatment (BMEAud+ Traditional Chinese Medicine Health Consultationud(TCM HC) may be effective for CPP. Previous EA studiesudhave demonstrated an analgesic effect. Large-scaleudstudies on acupuncture for other chronic painudconditions suggest that patient-healthcare providerudinteraction might play a role in pain reduction. Weudpropose a pilot study to explore the effectiveness of theudmeridian BMEA treatment in managing women withudCPP to inform a future large randomised controlled trial.udMethods and analysis: A 3-armed randomisedudcontrolled pilot study is proposed with an aim to recruitud30 women with CPP in National Health Service (NHS)udLothian. Randomisation will be to BMEA treatment,udTCM HC or standard care (SC). Validated pain, physicaludand emotional functioning questionnaires will beudadministered to all participants at weeks 0, 4, 8 and 12.udFocus group discussions will be conducted when weekud12 questionnaires are completed. The primary objectiveudis to determine, recruitment and retention rates. Theudsecondary objectives are to assess the effectiveness andudacceptability of the proposed methods of recruitment,udrandomisation, interventions and assessment tools.udEthics and dissemination: Ethical approval has beenudobtained from the Scotland Research Ethics Committeeud(REC 14/SS/1022). Data will be published in peer-reviewedudjournals and presented at internationaludconferences.