Chronic PainBMEANCT02295111
Electro-acupuncture (EA) and Chronic Pelvic Pain (CPP)
A study testing EA treatment and TCM health consult in people with Chronic Pain, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Pain
- What is being tested?
- EA treatment and TCM health consult
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Malignancy
- Severe bleeding disorders (e.g. Type 2, 3 Von Willebrand disease)
- Severe needle phobia
- Taking anti-coagulants
- A history of seizure
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ooi Thye Chong
Edinburgh, City of Edinburgh, EH16 4SA
About this 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.
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.
Read more
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.
- Conditions
- Chronic Pain
- Being tested
- EA treatment, TCM health consult, Usual Care
- Keywords
- electro-acupuncture, chronic pelvic pain, patient practitioner interactions, TCM health consultation, meridian balanced method acupuncture
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA treatmentDevice
Electro acupuncture and traditional Chinese Medicine Health consult
TCM health consultBehavioural
Traditional Chinese Medicine Health Consult without needling
Usual CareOther
Standard NHS care
| Study group | Role | What they receive |
|---|---|---|
| EA treatment and TCM health consult | Active comparator | Participants randomized to the EA treatment will receive 2 EA +TCM health consult once a week x 4 weeks (8 total) Receives: Device: EA treatment |
| TCM health consult | Experimental | Participants randomized to TCM health consult will receive 2 TCM health consult once a week x 4 weeks ( 8 total) Receives: Behavioral: TCM health consult |
| Usual care | Active comparator | Participants randomized to usual care will continue with their usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of study: 12 months from start of study
Secondary outcomes (9)
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.
Measured: 12 months from date of recruitment
VAS Scale
Questionnaire
Measured: At 0, 4, 8, 12 weeks
Brief Pain Inventory
Questionnaire
Measured: At 0, 4, 8, 12 weeks
Hospital Anxiety and Depression Scale
Questionnaire
Measured: at 0, 4, 8, 12 weeks
SF 12
Questionnaire
Measured: at 0, 4, 8, 12 weeks
Work Productivity & Activity Impairment Questionnaire
Questionnaire
Measured: at 0, 4, 8, 12 weeks
Sexual Activity Questionnaire
Questionnaire
Measured: at 0, 4, 8, 12 weeks
Pain Catastrophising Questionnaire
Questionnaire
Measured: at 0, 4, 8, 12 weeks
Focus Group Discussions
Qualitative Method
Measured: At the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Marie Fallon, MD PhD, Principal investigator, University of University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295111
- Sponsor's protocol ID
- 14/SS/1022
- Acronym
- BMEA
- Status last verified
- Nov 2015
- First submitted
- 23 Sep 2014
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chong OT, Critchley HO, Horne AW, Elton R, Haraldsdottir E, Fallon M. The BMEA study: the impact of meridian balanced method electroacupuncture on women with chronic pelvic pain-a three-arm randomised controlled pilot study using a mixed-methods approach. BMJ Open. 2015 Nov 17;5(11):e008621. doi: 10.1136/bmjopen-2015-008621.
PubMed 26576808
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02295111
- Acronym / sponsor ID
- BMEA / 14/SS/1022
- Conditions
- Chronic Pain
- Keywords
- electro-acupuncture, chronic pelvic pain, patient practitioner interactions, TCM health consultation, meridian balanced method acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EA treatment and TCM health consult | Active comparator | Device: EA treatmentParticipants randomized to the EA treatment will receive 2 EA +TCM health consult once a week x 4 weeks (8 total) |
| TCM health consult | Experimental | Behavioral: TCM health consultParticipants randomized to TCM health consult will receive 2 TCM health consult once a week x 4 weeks ( 8 total) |
| Usual care | Active comparator | Other: Usual CareParticipants randomized to usual care will continue with their usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Pregnancy
- Malignancy
- Severe bleeding disorders (e.g. Type 2, 3 Von Willebrand disease)
- Severe needle phobia
- Taking anti-coagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EA treatmentElectro acupuncture and traditional Chinese Medicine Health consult | Device | EA treatment and TCM health consult |
| TCM health consultTraditional Chinese Medicine Health Consult without needling | Behavioural | TCM health consult |
| Usual CareStandard NHS care | Other | Usual care |
Primary outcome
The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates within defined inclusion/exclusion criteria.
Time frame: 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.
9 secondary outcomes
The secondary objectives are to determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation, interventions and assessment tools.
Time frame: 12 months from date of recruitment
VAS Scale
Time frame: At 0, 4, 8, 12 weeks
Brief Pain Inventory
Time frame: At 0, 4, 8, 12 weeks
Hospital Anxiety and Depression Scale
Time frame: at 0, 4, 8, 12 weeks
SF 12
Time frame: at 0, 4, 8, 12 weeks
Work Productivity & Activity Impairment Questionnaire
Time frame: at 0, 4, 8, 12 weeks
Sexual Activity Questionnaire
Time frame: at 0, 4, 8, 12 weeks
Pain Catastrophising Questionnaire
Time frame: at 0, 4, 8, 12 weeks
Focus Group Discussions
Time frame: At the end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
- Derived from this study: PubMed 26576808Chong OT, Critchley HO, Horne AW, Elton R, Haraldsdottir E, Fallon M. The BMEA study: the impact of meridian balanced method electroacupuncture on women with chronic pelvic pain-a three-arm randomised controlled pilot study using a mixed-methods approach. BMJ Open. 2015 Nov 17;5(11):e008621. doi: 10.1136/bmjopen-2015-008621.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Fallon, MD PhD principal investigator
University of University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EA treatment and TCM health consult in people with Chronic Pain, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates within defined inclusion/exclusion criteria. (time frame: At the end of study: 12 months from start of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02295111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015.