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

NCT02295111 | Completed

• 1 other identifier: 14/SS/1022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

electro-acupuncture; chronic pelvic pain; patient practitioner interactions; TCM health consultation; meridian balanced method acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 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.

  12 months from date of recruitment

• VAS Scale

  At 0, 4, 8, 12 weeks

• Brief Pain Inventory

  At 0, 4, 8, 12 weeks

• Hospital Anxiety and Depression Scale

  at 0, 4, 8, 12 weeks

• SF 12

  at 0, 4, 8, 12 weeks

Study Arms (3)

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)

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)

Behavioral: TCM health consult

Usual care

ACTIVE COMPARATOR

Participants randomized to usual care will continue with their usual care

Other: Usual Care

Interventions

EA treatment DEVICE

Electro acupuncture and traditional Chinese Medicine Health consult

EA treatment and TCM health consult

TCM health consult BEHAVIORAL

Traditional Chinese Medicine Health Consult without needling

TCM health consult

Usual Care OTHER

Standard NHS care

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Ooi Thye Chong

Edinburgh, City of Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26576808 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Fallon, MD PhD

  University of University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: November 20, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 11, 2015

Record last verified: 2015-11

Locations

GB (1)