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

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.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: EA treatment; Behavioral: TCM health consult; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • City of Edinburgh
    • Edinburgh, City of Edinburgh, United Kingdom, EH16 4SA
      • Ooi Thye Chong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EA treatment and TCM health consult; Participants randomized to the EA treatment will receive 2 EA +TCM health consult once a week x 4 weeks (8 total)	Device: EA treatment; Electro acupuncture and traditional Chinese Medicine Health consult
Experimental: TCM health consult; Participants randomized to TCM health consult will receive 2 TCM health consult once a week x 4 weeks ( 8 total)	Behavioral: TCM health consult; Traditional Chinese Medicine Health Consult without needling
Active Comparator: Usual care; Participants randomized to usual care will continue with their usual care	Other: Usual Care; Standard NHS care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates within defined inclusion/exclusion criteria.	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.	At the end of study: 12 months from start of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary objectives are to determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation, interventions and assessment tools.	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.	12 months from date of recruitment
VAS Scale	Questionnaire	At 0, 4, 8, 12 weeks
Brief Pain Inventory	Questionnaire	At 0, 4, 8, 12 weeks
Hospital Anxiety and Depression Scale	Questionnaire	at 0, 4, 8, 12 weeks
SF 12	Questionnaire	at 0, 4, 8, 12 weeks
Work Productivity & Activity Impairment Questionnaire	Questionnaire	at 0, 4, 8, 12 weeks
Sexual Activity Questionnaire	Questionnaire	at 0, 4, 8, 12 weeks
Pain Catastrophising Questionnaire	Questionnaire	at 0, 4, 8, 12 weeks
Focus Group Discussions	Qualitative Method	At the end of study

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian
• Investigators: Principal Investigator: Marie Fallon, MD PhD, University of University

Publications and helpful links

General Publications

• Chong OT, Critchley HO, Horne AW, Elton R, Haraldsdottir E, Fallon M. 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. BMJ Open. 2015 Nov 17;5(11):e008621. doi: 10.1136/bmjopen-2015-008621.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: November 14, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Estimate): November 11, 2015
• Last Update Submitted That Met QC Criteria: November 10, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: electro-acupuncture; chronic pelvic pain; patient practitioner interactions; TCM health consultation; meridian balanced method acupuncture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Pelvic Pain
• Other Study ID Numbers: 14/SS/1022