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

Chronic Pain Clinical Trial

— BMEA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295111
• Other study ID #: 14/SS/1022
• Status: Completed
• Phase: N/A
• First received: September 23, 2014
• Last updated: November 10, 2015
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Pelvic Pain

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Ooi Thye Chong	Edinburgh	City of Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	VAS Scale	Questionnaire	At 0, 4, 8, 12 weeks	No
Secondary	Brief Pain Inventory	Questionnaire	At 0, 4, 8, 12 weeks	No
Secondary	Hospital Anxiety and Depression Scale	Questionnaire	at 0, 4, 8, 12 weeks	No
Secondary	SF 12	Questionnaire	at 0, 4, 8, 12 weeks	No
Secondary	Work Productivity & Activity Impairment Questionnaire	Questionnaire	at 0, 4, 8, 12 weeks	No
Secondary	Sexual Activity Questionnaire	Questionnaire	at 0, 4, 8, 12 weeks	No
Secondary	Pain Catastrophising Questionnaire	Questionnaire	at 0, 4, 8, 12 weeks	No
Secondary	Focus Group Discussions	Qualitative Method	At the end of study	No