NCT02295111

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	EA treatment	Electro acupuncture and traditional Chinese Medicine Health consult
BEHAVIORAL	TCM health consult	Traditional Chinese Medicine Health Consult without needling
OTHER	Usual Care	Standard NHS care

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-11-20
• Last updated: 2015-11-11

Locations

1 site across 1 country: United Kingdom