WestminsterResearch http://www.westminster.ac.uk/research/westminsterresearch Acupuncture during stroke rehabilitation: development of a manual for researching a complex intervention Claudia Citkovitz Faculty of Science and Technology This is an electronic version of a PhD thesis awarded by the University of Westminster. © The Author, 2015. This is an exact reproduction of the paper copy held by the University of Westminster library. The WestminsterResearch online digital archive at the University of Westminster aims to make the research output of the University available to a wider audience. Copyright and Moral Rights remain with the authors and/or copyright owners. Users are permitted to download and/or print one copy for non-commercial private study or research. Further distribution and any use of material from within this archive for profit-making enterprises or for commercial gain is strictly forbidden. Whilst further distribution of specific materials from within this archive is forbidden, you may freely distribute the URL of WestminsterResearch: (http://westminsterresearch.wmin.ac.uk/). In case of abuse or copyright appearing without permission e-mail [email protected] Acupuncture during Stroke Rehabilitation: Development of a Manual for Researching a Complex Intervention Claudia Citkovitz A thesis submitted in partial fulfilment of the requirements of the University of Westminster for the degree of Doctor of Philosophy This research programme was carried out in collaboration with Lutheran Medical Center January 2015 Abstract BACKGROUND AND AIMS Evidence on acupuncture during stroke rehabilitation is inconsistent, with methodological problems including inappropriately standardized treatment protocols. This project developed and assessed feasibility of methods to study an individualized acupuncture intervention during acute stroke rehabilitation. DESIGN AND METHODS This three-part project aimed to 1) develop a manual for post-stroke acupuncture therapy; 2) determine feasibility of methods for future study and 3) explore stakeholder perceptions of acupuncture’s impact. First, a treatment manual was developed. Second, a cohort study used the manual to treat 48 inpatients, who had elected acupuncture treatment (n=25) or usual care only (n=23). Acupuncture was given 3-4 times weekly for 2-4 weeks. Outcomes assessed for feasibility included the Functional Independence Measure (FIM), Modified Rankin Scale of global disability (mRS) and assessments of sleep, swallowing and bowel function (at baseline and discharge, with mRS also at 6-month follow-up). Confidence intervals were compared across mild, moderate and severe subgroups. The third study assessed stakeholder perceptions of acupuncture impact. Acupuncture patients were briefly interviewed, with surveys given to family, rehabilitation therapists, nurses and physicians. Impacts of acupuncture were identified using thematic analysis, and compared quantitatively across severity groups. RESULTS Improvement in FIM scores was similar in self-selected cohorts choosing acupuncture (Mdn=37.5) and usual care (Mdn=35), 95% CI [-6, 6]. FIM ii motor domain scores trended higher in the moderate subgroup only. Feasibility criteria were met for the outcomes of 6-month mRS, bowel function, and sleep. Findings of Project 3 included a wide range of perceived benefits, with no negative impact. Benefits included improved upper and lower extremity motor function, walking, relaxation, and pain reduction. Staff reported better mood and participation in physical and occupational therapy. Reported benefits differed across severity subgroups, but proportion of stakeholders perceiving benefit was similar. CONCLUSIONS Further research on acupuncture during stroke rehabilitation is feasible, given mutually appropriate intervention, patient population and outcome measures. The widely used FIM appears inappropriate for future study, except possibly for patients in the moderate range of severity. No outcome reached statistical significance in this small non-randomized study. Trends favored the acupuncture group on most secondary outcomes including 6-month mRS, sleep and bowel function. Additional directions for further study include the relationship between cortical damage and acupuncture responsiveness, and possible benefit to the rehabilitation process itself. iii Table of Contents ABSTRACT ............................................................................................................... II TABLE OF CONTENTS ............................................................................................. IV LIST OF FIGURES ................................................................................................... XII LIST OF TABLES .................................................................................................... XIII ACKNOWLEDGMENTS ......................................................................................... XIV DEDICATION ........................................................................................................ XVI AUTHOR’S DECLARATION ................................................................................... XVII 1 CHAPTER 1: INTRODUCTION .......................................................................... 18 1.1 Project Overview .................................................................................................... 18 1.2 Chapter Summary .................................................................................................. 20 1.3 Conventions Regarding Chinese Medical Terminology .................................... 22 2 CHAPTER 2: CLINICAL AND HISTORICAL BACKGROUND ................................ 24 2.1 Physiology, Clinical Management and Societal Burden of Stroke in Contemporary Society .................................................................................................... 25 2.1.1 Stroke Recovery: Disease Course and Clinical Management ......................... 26 2.1.2 Stroke Rehabilitation: Assessment and Clinical Management of Stroke Sequelae ....................................................................................................................... 29 2.1.3 Chronic and Long-Term Stroke Care and Societal Burden .............................. 39 2.2 Stroke in Chinese Medical History ....................................................................... 41 2.2.1 200 B.C.E. – Huang Di Nei Jing ....................................................................... 41 2.2.2 200 C.E. – Zhang Zhong Jing .......................................................................... 43 iv 2.2.3 Liu Wansu (1120-1200), Zhu Dan Xi (1281-1358), Li Dong Yuan (1180-1251) 44 2.2.4 Wang Qing-Ren (1768-1831) ........................................................................... 44 2.2.5 Zhang Xi-Chun (1860-1933) ............................................................................. 46 2.2.6 Contemporary Clinical Practice ........................................................................ 47 2.3 Acupuncture in Post-Stroke Care: Contemporary Research ........................... 50 2.3.1 Mechanisms Research in Acupuncture for Stroke ........................................... 51 2.3.2 Clinical Research ............................................................................................. 53 2.3.3 Methodological Considerations ........................................................................ 59 2.4 Synthesis and Research Questions for this Project .......................................... 62 3 CHAPTER 3: RESEARCH METHODOLOGY AND DESIGN DECISIONS ................. 64 3.1 Research Methodologies previously used to engage clinical complexity ....... 65 3.1.1 Qualitative Research ........................................................................................ 66 3.1.2 Mixed Methods Research ................................................................................. 69 3.1.3 Participatory Action Research .......................................................................... 71 3.1.4 Comparative Effectiveness Research .............................................................. 72 3.1.5 Whole Systems Research ................................................................................ 73 3.1.6 Complex Interventions Research ..................................................................... 75 3.1.7 Manualization ................................................................................................... 77 3.1.8 Synthesis and Implications for this Project ....................................................... 77 3.2 Design Decisions ................................................................................................... 80 3.2.1 Methodology and Overall Design for this Project ............................................. 80 3.2.2 Investigation 1: Development of a Treatment Manual for Acupuncture during Acute Stroke Rehabilitation .......................................................................................... 81 3.2.3 Investigation 2: Concurrent Cohort Study of Manualized Acupuncture ........... 84 3.2.4 Investigation 3: Qualitative and Quantitative Exploration of Stakeholder Perceptions of Acupuncture’s Impact ........................................................................... 86 3.2.5 Feasibility Assessment ..................................................................................... 86 3.3 Synthesis ...............................................................................................................