title: 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.
abstract: BACKGROUND
  Chronic pelvic pain (CPP) affects 3-4% of women worldwide. Proven treatments for CPP are limited and unsatisfactory. The meridian balance method (BM) electroacupuncture (EA) treatment (BMEA + Traditional Chinese Medicine Health Consultation (TCM HC) may be effective for CPP. Previous EA studies have demonstrated an analgesic effect. Large-scale studies on acupuncture for other chronic pain conditions suggest that patient-healthcare provider interaction might play a role in pain reduction. We propose a pilot study to explore the effectiveness of the meridian BMEA treatment in managing women with CPP to inform a future large randomised controlled trial.
  
  
  METHODS
  A 3-armed randomised controlled pilot study is proposed with an aim to recruit 30 women with CPP in National Health Service (NHS) Lothian. Randomisation will be to BMEA treatment, TCM HC or standard care (SC). Validated pain, physical and emotional functioning questionnaires will be administered to all participants at weeks 0, 4, 8 and 12. Focus group discussions will be conducted when week 12 questionnaires are completed. The primary objective is to determine, recruitment and retention rates. The secondary objectives are to assess the effectiveness and acceptability of the proposed methods of recruitment, randomisation, interventions and assessment tools.
  
  
  BACKGROUND
  Ethical approval has been obtained from the Scotland Research Ethics Committee (REC 14/SS/1022). Data will be published in peer-reviewed journals and presented at international conferences.
  
  
  BACKGROUND
  NCT02295111.
authors.affiliation: MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK.
authors.forename: Ooi Thye
authors.initials: OT
authors.lastname: Chong
authors.affiliation: MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK.
authors.forename: Hilary O D
authors.initials: HO
authors.lastname: Critchley
authors.affiliation: MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK.
authors.forename: Andrew W
authors.initials: AW
authors.lastname: Horne
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Elton
authors.affiliation: St. Columba's Hospice, Edinburgh, UK.
authors.forename: Erna
authors.initials: E
authors.lastname: Haraldsdottir
authors.affiliation: Cancer Research Centre, University of Edinburgh, Edinburgh, UK.
authors.forename: Marie
authors.initials: M
authors.lastname: Fallon
mesh_terms: D000328:Adult; D059350:Chronic Pain / Q000628:therapy*; D015671:Electroacupuncture / Q000379:methods*; D005260:Female; D006801:Humans; D016740:Meridians; D008875:Middle Aged; D010147:Pain Measurement; D017699:Pelvic Pain / Q000628:therapy*; D010865:Pilot Projects; D012107:Research Design; D012606:Scotland; D011795:Surveys and Questionnaires
keywords: chronic pelvic pain; context effects; electro-acupuncture; mixed methods research