Clinical trial NCT02295111: Electro-acupuncture (EA) and Chronic Pelvic Pain (CPP)
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: electro-acupuncture
chronic pelvic pain
patient practitioner interactions
TCM health consultation
meridian balanced method acupuncture
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2014-11-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates within defined inclusion/exclusion criteria.
timeFrame: At the end of study: 12 months from start of study
Secondary outcomes:
measure: The secondary objectives are to determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation, interventions and assessment tools.
timeFrame: 12 months from date of recruitment
measure: VAS Scale
timeFrame: At 0, 4, 8, 12 weeks
measure: Brief Pain Inventory
timeFrame: At 0, 4, 8, 12 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: at 0, 4, 8, 12 weeks
measure: SF 12
timeFrame: at 0, 4, 8, 12 weeks
measure: Work Productivity & Activity Impairment Questionnaire
timeFrame: at 0, 4, 8, 12 weeks
measure: Sexual Activity Questionnaire
timeFrame: at 0, 4, 8, 12 weeks
measure: Pain Catastrophising Questionnaire
timeFrame: at 0, 4, 8, 12 weeks
measure: Focus Group Discussions
timeFrame: At the end of study
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Ooi Thye Chong
state: City of Edinburgh
Study officials:
affiliation: University of University
name: Marie Fallon, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.