Table Of ContentCitation: Clarkson, Carl (2016) Korean Hand Acupuncture for Pregnancy Related Pelvic
Girdle Pain: a feasibility study. Doctoral thesis, Northumbria University.
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KOREAN HAND ACUPUNCTURE FOR
PREGNANCY RELATED PELVIC
GIRDLE PAIN: A FEASIBILITY STUDY
C E CLARKSON
PhD
2016
i
KOREAN HAND ACUPUNCTURE FOR
PREGNANCY RELATED PELVIC
GIRDLE PAIN: A FEASIBILITY STUDY
CARL ERNEST CLARKSON
A thesis submitted in partial fulfilment of
the requirements for Northumbria
Univeristy for the degree of Doctor of
Philosophy
Research undertaken in the School of
Health and Life Sciences
May 2016
ii
Abstract
This thesis aimed to assess the feasibility of conducting a randomised controlled trial
(RCT) into the use of Korean Hand Acupuncture (KHA) for pregnancy related pelvic gir-
dle pain (PPGP). Despite PPGP developing in approximately 20% of all pregnant
women, there are currently very few studies that have investigated interventional strate-
gies, with a dearth of UK based studies. Of extant interventions investigated to date, ac-
upuncture has shown some promising findings, although the effects of KHA on PPGP re-
main unclear. In line with the MRC framework for complex interventions, any potential
treatment should be subjected to feasibility testing prior to a definitive RCT. This three
phase feasibility study followed a mixed methods paradigm.
Phase 1 was a comparative study of 20 non pregnant women, measuring the belief that
there had been a needle inserted into the skin, between a penetrating KHA (pKHA)
group and a non-penetrating KHA (npKHA) group. Between group analysis found that at
initial assessment (p=0.07) and one week post intervention (p=0.643), believability was
similar. Qualitative comments were analysed through content analysis, and provided in-
sight into what factors influenced their belief score, such as ‘acupuncture noises’. The
study findings helped to develop the intervention protocol in Phase 3. This study was the
first to investigate the believability of a non penetrating form of KHA.
Phase 2 recruited eight PPGP sufferers and adopted a qualitative approach, using semi-
structured interviews to gain an understanding of how PPGP affected them. Data was
subjected to thematic analysis and produced four themes: The reality of PPGP; Support
mechanisms most important in PPGP; Vulnerability and; Knowledge is power. Findings
indicated PPGP is a problem that is biopsychosocial, and one which is represented via
the Pelvic Girdle Questionnaire (PGQ). It demonstrated that information provision was
considered as important to the participants within this study as it is to sufferers outside of
the UK, and that they valued health care professional advice and support. This is the first
UK based study to investigate women’s experience of PPGP, the first piece of qualitative
work with the lead author and interviewer being male, the first to provide a level of valid-
ity to PGQ use within the UK and the first to adopt a pragmatic philosophy.
Phase 3 was a mixed methods feasibility study, assessing the acceptability and practi-
cality of conducting a definitive RCT on KHA for PPGP. A two armed study consisting of
six sessions in either a standard physiotherapy plus pKHA or a standard physiotherapy
plus npKHA group. The study recruited 59 women, 40 of whom completed all six ses-
sions. Acceptability and practicality was confirmed through content analysis of the quali-
tative data produced by the participants, in particular those in the pKHA group who
stated they would seek out the treatment again. Further acceptability was noted as all
adverse events experienced were minor and transient, and that the retention of women
to the study was greater than normally expected from the study population. In addition,
trends noted in NRS at present (p=0.002) and PGQ (p=0.041) at the final data point indi-
cated that pKHA may have additional benefits over npKHA for PPGP. The original contri-
butions from Phase 3 are that it is the first study to be conducted using KHA for a preg-
nancy related condition in the English language and the first study to adopt a mixed
methods approach within the UK for an acupuncture study within pregnancy. Finally, it is
the first study written in English that has compared pKHA to npKHA for any condition.
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Contents
Abstract iii
Contents iv
List of Appendices xi
Table’s xii
Figures xiv
List of Abbreviations xv
Acknowledgements xvii
Declaration xviii
Chapter 1 – Introduction 1
1.1 Introduction 1
Chapter 2 – Pregnancy related Pelvic Girdle Pain: Background 10
2.1 Defining PPGP 10
2.2 The diagnosis of PPGP 12
2.3 The symptoms and impact of PPGP 14
2.4 Potential causes of PPGP 24
2.5 Epidemiology of PPGP: Incidence and prevalence 27
2.6 Post-partum pain 32
2.7 Chapter summary 37
Chapter 3 – Management and Interventional Approaches for Pregnancy related
Pelvic Girdle Pain 38
3.1 Background 38
3.2 Medication use 39
3.3 Physiotherapy in PPGP 40
3.4 The use of acupuncture in PPGP 43
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3.5 Safety of acupuncture in pregnancy 47
3.6 Acupuncture for PPGP 49
3.7 Outcome measures 63
3.8 Acupuncture mechanisms 65
3.9 Background to placebo 68
3.10 Physiology of placebo acupuncture 72
3.11 The placebo effect 74
3.12 Distinguishability 78
3.13 Chapter summary 83
Chapter 4 – Overview of Methodology 86
4.1 The MRC guideline as a framework 86
4.2 Pragmatism 90
4.3 Research paradigms 92
4.4 Use of MMR in acupuncture 98
4.5 Implementation of MMR for this thesis 102
4.6 Chapter summary 103
Chapter 5 – Development of an Intervention Protocol for Korean
Hand Acupuncture 105
5.1 Introduction to Chapter 105
5.2 Measurement of Believability 106
5.3 Outcome measures for Distinguishability and Credibility 108
5.4 Sampling in previous acupuncture distinguishability studies 110
5.5 Aims 110
5.6 Hypothesis 110
5.7 Null Hypothesis 110
5.8 Methods 111
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5.8.1 Ethical approval 111
5.8.2 Study design 111
5.8.3 Sample 111
5.8.4 Inclusion criteria 112
5.8.5 Blinding 112
5.8.6 Recruitment 112
5.8.7 Randomisation 113
5.8.8 Outcome measure 113
5.8.9 Procedure 113
5.8.10Data analysis 114
5.8.11Recording of adverse events 115
5.9 Results 116
5.9.1 Adverse events 116
5.9.2 Study attrition 116
5.9.3 General demographics 116
5.9.4 Initial opinion of intervention received 117
5.9.5 Opinion of intervention after one week 118
5.9.6 Within group comparisons 119
5.9.7 Between group comparisons 120
5.9.8 Emerging Themes from believability qualitative comments 120
5.10 Discussion 121
5.10.1 Implications for future research 122
5.10.2 Strengths of the study 125
5.10.3 Limitations of the study 125
5.11 Chapter summary 127
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Chapter 6 - Qualitative Interviews with Pregnancy related Pelvic Girdle
Pain Sufferers 130
6.1 Background literature 130
6.2 Study Aim 134
6.3 Methods 134
6.4 Ethics 134
6.5 Sampling and recruitment 135
6.6 Data collection 135
6.7 Data analysis 138
6.8 Reflexivity 142
6.9 Results 144
6.9.1 The Reality of PPGP 148
6.9.2 Support mechanisms most important in PPGP 151
6.9.3 Vulnerability 155
6.9.4 Knowledge is power 156
6.10 Discussion 159
6.10.1 Symptoms of PPGP 160
6.10.2 Information provision 161
6.10.3 Support network 162
6.10.4 Expectations and treatment 164
6.10.5 Sick leave 165
6.10.6 Recommendations for future practice 166
6.10.7 Potential future research 168
6.10.8 Study strengths 169
6.10.9 Study limitations 170
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6.10.10 Benefits to the researcher 171
6.10.11 Chapter summary 172
Chapter 7 - Korean Hand Acupuncture for Pregnancy related Pelvic
Girdle Pain: A Feasibility Study 174
7.1 Background literature 174
7.2 Outcome measures for feasibility testing with PPGP 176
7.3 Informing the delivery method 179
7.4 Aim 182
7.5 Method 182
7.5.1 Study design 182
7.5.2 Ethics 183
7.5.3 Recruitment (Women's health Physiotherapy Department) 183
7.5.4 Sample size 184
7.5.5 Inclusion criteria 184
7.5.6 Outcome measures 185
7.5.7 Location 185
7.5.8 Procedure 185
7.5.9 Adverse event reporting 187
7.5.10 Randomisation 188
7.5.11 Blinding 188
7.5.12 Data analysis 189
7.5.13 Costs 190
7.5.14 Timescale 190
7.6 Results 191
7.6.1 Number of eligible patients/
willingness of participants to be randomised 192
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7.6.2 Study attrition/the practicality of delivering the
intervention(s) in the proposed setting 192
7.6.3 Willingness of clinicians to identify potential participants 193
7.6.4 Time needed to collect data 194
7.6.5 Suitability of the outcome measures used 194
7.6.6 Acceptability of pKHA and npKHA 195
7.6.7 Recording of adverse events 198
7.6.8 Physiotherapy staff views on study 198
7.6.9 Making between and within group comparisons
on any emerging trends within the data 199
7.6.10 General demographics 199
7.6.11 Credibility and Believability of KHA 202
7.6.12 Outcome measure completion 205
7.6.13 Participants views and experiences 213
7.6.14 Results summary 215
7.7 Discussion 216
7.7.1 Feasibility and Practicality 216
7.7.2 Acceptability and Credibility 218
7.7.3 Recruitment and attrition 219
7.7.4 Trends in intervention outcome 221
7.7.5 Suitability of the outcome measures: Pain 222
7.7.6 Suitability of the outcome measures: Function and ADL 224
7.7.7 Potential pain mechanisms involved 225
7.7.8 Study strengths 229
7.7.9 Study limitations 230
7.7.10 Future research 232
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Description:(RCT) into the use of Korean Hand Acupuncture (KHA) for pregnancy related pelvic gir- dle pain (PPGP). Despite PPGP developing in approximately
