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Completed

NCT Number: NCT02295111

Electro-acupuncture (EA) and Chronic Pelvic Pain (CPP)

Chronic pelvic pain (CPP) is a debilitating condition that affects over 1 million women in the United Kingdom. The annual healthcare costs are estimated at over £150 million. Proven interventions which include the use of analgesics or hormonal treatments are unsatisfactory in many cases.

The investigators believe that the meridian balance method (BM) electro-acupuncture (EA) treatment (which includes a Traditional Chinese Medicine Health Consultation [TCM HC]) may be helpful in the management of CPP. Studies on the mechanisms of EA have demonstrated an analgesic effect. A recent individual patient data meta-analysis on the use of acupuncture for four chronic pain conditions found a small statistically significant effect size when compared to sham acupuncture. The effect size was larger and statistically significant when compared to usual care controls. This meta-analysis, and other large studies, suggests that, in addition to this analgesic effect, the interaction between the patient and the healthcare provider also plays a role in its effect on painful symptoms.

Our hypothesis is that the meridian BMEA treatment alleviates pain, and improves physical and emotional functioning, in women with CPP.

The investigators plan to undertake a single centre pilot study to assess the feasibility of performing a future three-armed randomised controlled, parallel group design trial to determine the efficacy of the meridian balance method electro-acupuncture (BMEA) treatment in the management of women with CPP.

The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates within defined inclusion/exclusion criteria.

The secondary objectives are to determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation, interventions and assessment tools.

The investigators aim to recruit 30 women with CPP in NHS Lothian over a 12-month period and randomise them to BMEA treatment, TCM HC or standard care (SC). Response to the intervention will be monitored by validated pain, physical and emotional functioning questionnaires at weeks 0 (baseline), 4 (end of study) 8 and 12. Focus group discussion to gain feedback on study experience will be conducted at the completion of the study.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ooi Thye Chong

Edinburgh, City of Edinburgh, EH16 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic pelvic pain longer than 6 months duration
  • Average numerical pain score of at least 4 out of 10 in the previous week
  • Able and willing to comply with intervention
  • Women aged 18 and above

Exclusion criteria

  • Pregnancy
  • Malignancy
  • Severe bleeding disorders (e.g. Type 2, 3 Von Willebrand disease)
  • Severe needle phobia
  • Taking anti-coagulants
  • A history of seizure
  • A pace-maker in situ
  • Moderate to severe psychiatric illness (currently under the care of a psychiatrist)
  • Had received electro-acupuncture and meridian balanced method within the last 6 months

Treatment and study plan

EA treatment

Device

Electro acupuncture and traditional Chinese Medicine Health consult

TCM health consult

Behavioral

Traditional Chinese Medicine Health Consult without needling

Usual Care

Other

Standard NHS care

Primary outcomes

  1. The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates within defined inclusion/exclusion criteria.

    Time frame: At the end of study: 12 months from start of study

    We aim to recruit 30 women with CPP in NHS Lothian over a 12-month period and randomise them to BMEA treatment, TCM HC or standard care (SC). Response to the intervention will be monitored by validated pain, physical and emotional functioning questionnaires at weeks 0 (baseline), 4 (end of study) 8 and 12. Focus group discussion to gain feedback on study experience will be conducted at the completion of the study.

Secondary outcomes

  1. The secondary objectives are to determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation, interventions and assessment tools.

    Time frame: 12 months from date of recruitment

    We aim to recruit 30 women with CPP in NHS Lothian over a 12-month period and randomise them to BMEA treatment, TCM HC or standard care (SC). Response to the intervention will be monitored by validated pain, physical and emotional functioning questionnaires at weeks 0 (baseline), 4 (end of study) 8 and 12. Focus group discussion to gain feedback on study experience will be conducted at the completion of the study.

  2. VAS Scale

    Time frame: At 0, 4, 8, 12 weeks

    Questionnaire

  3. Brief Pain Inventory

    Time frame: At 0, 4, 8, 12 weeks

    Questionnaire

  4. Hospital Anxiety and Depression Scale

    Time frame: at 0, 4, 8, 12 weeks

    Questionnaire

  5. SF 12

    Time frame: at 0, 4, 8, 12 weeks

    Questionnaire

  6. Work Productivity & Activity Impairment Questionnaire

    Time frame: at 0, 4, 8, 12 weeks

    Questionnaire

  7. Sexual Activity Questionnaire

    Time frame: at 0, 4, 8, 12 weeks

    Questionnaire

  8. Pain Catastrophising Questionnaire

    Time frame: at 0, 4, 8, 12 weeks

    Questionnaire

  9. Focus Group Discussions

    Time frame: At the end of study

    Qualitative Method

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

The BMEA Study: The Impact of Meridian Balanced Method (BM) Electro-acupuncture (EA) Treatment on Women With Chronic Pelvic Pain (CPP): A Three-arm Randomized Controlled Pilot Study.

Acronym: BMEA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2014
Registry last updated
Nov 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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