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

Sponsor

University of Edinburgh (Other)

Overall Status

Completed

CT.gov ID

NCT02295111

Collaborator

NHS Lothian (Other)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: EA treatment Behavioral: TCM health consult Other: Usual Care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: EA treatment and TCM health consult

Participants randomized to the EA treatment will receive 2 EA +TCM health consult once a week x 4 weeks (8 total)

Device: EA treatment

Electro acupuncture and traditional Chinese Medicine Health consult

Experimental: TCM health consult

Participants randomized to TCM health consult will receive 2 TCM health consult once a week x 4 weeks ( 8 total)

Behavioral: TCM health consult

Traditional Chinese Medicine Health Consult without needling

Active Comparator: Usual care

Participants randomized to usual care will continue with their usual care

Other: Usual Care

Standard NHS care

Outcome Measures

Primary Outcome Measures

The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates within defined inclusion/exclusion criteria. [At the end of study: 12 months from start of study]
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.

Secondary Outcome Measures

The secondary objectives are to determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation, interventions and assessment tools. [12 months from date of recruitment]
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.
VAS Scale [At 0, 4, 8, 12 weeks]
Questionnaire
Brief Pain Inventory [At 0, 4, 8, 12 weeks]
Questionnaire
Hospital Anxiety and Depression Scale [at 0, 4, 8, 12 weeks]
Questionnaire
SF 12 [at 0, 4, 8, 12 weeks]
Questionnaire
Work Productivity & Activity Impairment Questionnaire [at 0, 4, 8, 12 weeks]
Questionnaire
Sexual Activity Questionnaire [at 0, 4, 8, 12 weeks]
Questionnaire
Pain Catastrophising Questionnaire [at 0, 4, 8, 12 weeks]
Questionnaire
Focus Group Discussions [At the end of study]
Qualitative Method

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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