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

Study Overview
=================
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.

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.

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: EA treatment
* Behavioral: TCM health consult
* Other: Usual Care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EA treatment and TCM health consult<br>Participants randomized to the EA treatment will receive 2 EA +TCM health consult once a week x 4 weeks (8 total) | Device: EA treatment<br>* Electro acupuncture and traditional Chinese Medicine Health consult<br>|
| Experimental: TCM health consult<br>Participants randomized to TCM health consult will receive 2 TCM health consult once a week x 4 weeks ( 8 total) | Behavioral: TCM health consult<br>* Traditional Chinese Medicine Health Consult without needling<br>|
| Active Comparator: Usual care<br>Participants randomized to usual care will continue with their usual care | Other: Usual Care<br>* Standard NHS care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| VAS Scale | Questionnaire | At 0, 4, 8, 12 weeks | 
| Brief Pain Inventory | Questionnaire | At 0, 4, 8, 12 weeks | 
| Hospital Anxiety and Depression Scale | Questionnaire | at 0, 4, 8, 12 weeks | 
| SF 12 | Questionnaire | at 0, 4, 8, 12 weeks | 
| Work Productivity & Activity Impairment Questionnaire | Questionnaire | at 0, 4, 8, 12 weeks | 
| Sexual Activity Questionnaire | Questionnaire | at 0, 4, 8, 12 weeks | 
| Pain Catastrophising Questionnaire | Questionnaire | at 0, 4, 8, 12 weeks | 
| Focus Group Discussions | Qualitative Method | At the end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electro-acupuncture, chronic pelvic pain, patient practitioner interactions, TCM health consultation, meridian balanced method acupuncture