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