Ooi Thye Chong May 2016 SEUD Barcelona
������Electro-acupuncture (EA) treatment for women with chronic pelvic pain (CPP): a three-arm randomised controlled pilot study using a mixed methods approach ���
Burdens of Chronic Pelvic Pain
• Societal: UK estimated annual healthcare cost at 200 million Euros
• Personal: disrupted sleep & sex life, depression, anxiety, fatigue
• Social: Difficulty conducting social activities
• Employment: Fear of losing paid work Davies L et al J. Obstet Gynecol 1992
Effec;ve for other chronic pain condi;ons e.g. headache, back, neck & shoulder pain Vickers, AJ. Arch Intern Med. 2012 Haake, M. Arch Intern Med. 2007
Acupuncture & Chronic Pain
Electro-‐acupuncture (EA) treatment alleviates pain, improves
func;oning and wellbeing in women with CPP
Hypothesis
Primary: • recruitment rates • retention rates
Secondary: • Effectiveness • acceptability of proposed methods of recruitment & assessment tools
Objectives
Study Design 3-armed RCT comparing:
1. Electro-acupuncture treatment 2. TCM HC 3. Standard Care (SC)
A mixed methods approach: Quantitative (validated questionnaires) Qualitative (focus groups discussion)
Components of EA treatment: Traditional Chinese Medicine health consultation (TCM HC) +
Acupuncture needling + Electro-stimulation
1. CPP longer than 6 months 2. Average pain score of at least
4/10 in the previous week 3. Able & willing to comply with
intervention 4. Women aged 18 and above
Inclusion Criteria
1. Pregnancy 2. Malignancy 3. On anti-coagulant 4. A pace maker in-situ 5. Treatment with EA within the
past 6 months
Exclusion Criteria
Participants’+Flowchart++
Identify women with CPP
TCM HC N= 10 GP 2
EA + TCM HC N= 10 GP1
SC N= 10 GP 3
Eligible women with CPP
Baseline Qs repeat: 4, 8, 12 weeks
Focus Groups Research Outcomes
1°: retention & recruitment rates 2°: effectiveness & acceptability of interventions, data collection tools
Experience of study
Consent
Screening
Randomisation
Data Collection Reasons not enrolled: fall in the exclusion criteria
Adverse Events
Reasons for withdrawal
Screening Failures VAS BPI SAQ PCQ HADS WPAIQ SF12
Week 0 (Baseline)
Recruitment Rate = 51%
Ineligible = 28 • 12 unable to commit time • 4 not interested • 7 medically ineligible • 5 uncontactable
Screen failure = 1
No of Patients referred=59
Consented= 31 (52%)
Randomised= 30 (51% CI 38-63%)
!
Results:!Recruitment!Target!Vs!Randomised!!(3!months!ahead!of!schedule)!!
!
0!
5!
10!
15!
20!
25!
30!
35!
Oct>14!
Nov>14!
Dec>14!
Jan>15!
Feb>15!
Mar>15!
Apr>15!
May>15!
Jun>15!
Jul>15!
Aug>15!
Sep>15!
Target!recruitment!
Randomised!
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Group1(95%CI63-90%) Group2(95%CI36-70%) Group3(95%CI74-96%)
Renten%onRate:Ques%onnaireReturn(%)
Secondary Results & Findings
• A trend towards improvement (P<0.05) in the intervention groups compared to SC in pain (Visual Analog Score) & sleep
• Thematic analysis of focus groups data: perceived improvement in pain, sleep & energy in the intervention groups
Quote From A Participant
“ I went through four years… pacing the floor at night time or having broken sleep…When I started on acupuncture, I could sleep through the night.”
Conclusions
• Supports the feasibility of a future large scale RCT • Provides preliminary data that EA
could be effective in CPP
Acknowledgement
Professors M. Fallon, H. Critchley, A. Horne Drs E. Haraldsdottir & R. Elton
Funding: • MRC Centre for Reproductive Health • The Barbour Watson Trust, Edinburgh Palliative &
Supportive Care Research Fund • Morag Robinson Legacy & Alexander Dykes Fund Ann Doust, Trial Manager, Nic Watson, Research Nurse Harriet Harris & Sheila Milne, PAs