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 girdle pain (PPGP). Despite PPGP developing in approximately 20% of all pregnant women, there are currently very few studies that have investigated interventional strategies, with a dearth of UK based studies. Of extant interventions investigated to date, acupuncture has shown some promising findings, although the effects of KHA on PPGP remain 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 insight 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 semistructured 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 validity 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 practicality 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 sessions. Acceptability and practicality was confirmed through content analysis of the qualitative 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 indicated that pKHA may have additional benefits over npKHA for PPGP. The original contributions from Phase 3 are that it is the first study to be conducted using KHA for a pregnancy 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.
|Publication status||Accepted/In press - May 2016|