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

University of Edinburgh

Status: Completed

Conditions: Chronic Pain

Treatments: Other: Usual Care; Behavioral: TCM health consult; Device: EA treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02295111

14/SS/1022

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

EA treatment and TCM health consult

Active Comparator group

Description:

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

Treatment:

Device: EA treatment

TCM health consult

Experimental group

Description:

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

Treatment:

Behavioral: TCM health consult

Usual care

Active Comparator group

Description:

Participants randomized to usual care will continue with their usual care

Treatment:

Other: Usual Care