Ignite Creation Date:
2024-05-06 @ 3:27 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02295111
Status:
COMPLETED
Last Update Posted:
2015-11-11
First Post:
2014-09-23
Brief Title:
Electro-acupuncture EA and Chronic Pelvic Pain CPP
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BMEA
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 inclusionexclusion 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
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 inclusionexclusion 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None