Chronic Pain Clinical Trial
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.
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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