‘Forging a conviction’ – participants’ experiences of a western acupuncture randomised controlled trial

Abstract

Research into acupuncture has shown that individuals continue to report
favourable clinical effects despite the lack of systematic evidence supporting a
point specific therapeutic effect for real acupuncture treatment. This thesis
presents a qualitative study, nested within a large randomised controlled trial of
acupuncture specifically designed to investigate both specific and non-specific
effects of western acupuncture for osteoarthritis pain. The aim was to explore the
non specific effects of acupuncture in a trial context from the participants’
perspective, in particular the therapeutic relationship and any additional
influences on the patient experience that might lead to non-specific effects on
outcomes.

Participants were recruited from hip or knee joint replacement waiting lists and
randomised to one of three treatments (real acupuncture or 2 placebo controls)
and one of two consultation conditions (empathic or non- empathic). The
qualitative methodology was grounded theory. Data collection combined 27 post
trial audio taped, semi structured interviews with post treatment debriefing,
participant and non participant observation and personal reflections.

The findings of this study identified a core category of ‘forging a conviction’
and a substantive theory of ‘active trial participation’ was developed. Participants
gave reasons for entering the trial and for maintaining their commitment to it,
despite numerous barriers. These experiences helped to forge convictions about
the trial interventions and their effects. As a result a combination of specific and
non specific influences appeared to impact on the participants’ reporting of
outcomes, leading to discrepancies between the quantitative and qualitative data.

This theory of ‘active participation’ in clinical trials challenges some of the
basic assumptions of randomized controlled trials, most notably that participants
are passive recipients of an intervention and report its effects factually.

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