The Effect of Electro-Acupuncture on Reducing Opioid Consumption in Patients with Chronic Pain

223 Pages·2007·1.3 MB·English

The Effect of Electro-Acupuncture on Reducing
Opioid Consumption in Patients with Chronic Pain:
A Randomised Controlled Clinical Trial

Run Xiang Guo
Master of Applied Science

2006
RMIT
The Effect of Electro-Acupuncture on Reducing
Opioid Consumption in Patients with Chronic Pain:
A Randomised Controlled Clinical Trial

A thesis submitted in fulfilment of the requirements for
the degree of Master of Applied Science

Run Xiang Guo
B.Med

School of Health Sciences
RMIT University
August 2006
DECLARATION
I declare that except where due acknowledgement has been made, the work is that of the
author alone; the work has not been submitted previously, in whole or in part, to qualify for
any other academic award; the content of the thesis is the result of work which has been
carried out since the official commencement date of the approved research program; and, any
editorial work, paid or unpaid, carried out by a third party is acknowledged.

Run Xiang Guo
26 August 2006

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ACKNOWLEDGEMENTS
I would like to extend my sincere gratitude to my supervisors, Dr Zhen Zheng, Professor
Charlie Changli Xue and Professor Robert Helme for their constant inspiration, guidance,
encouragement and friendship throughout my study for this degree. Without all their supports,
this thesis would not have been possible.
I would like to thank Dr Andrew Muir, Ms Jean Bradbury and Dr Jean Trinca, who took the
time to help and advise on the process of clinical trial; and to thank all staffs in Barbara
Walker Centre for Pain Clinic of St. Vincent’s Hospital in Melbourne, for their administrative
assistance. I wish to thank the Division General Practices in Melbourne for their promotion
for the recruitment patients. I also would like to thank Associate Clifford Da Costa for his
statistical advice and data analyses, Ms Yanyi Wang for her kind data entry and summary, and
all staffs and colleagues in the Division of Chinese Medicine of RMIT University for their
assist and help during my study. This thesis would not have been completed without their
help. I am grateful to Mr. Peter Coxeter and Ms Melody Parker for the thesis proofreading.
My sincere appreciation is extended to Australian Postgraduate Awards funded by the
Commonwealth Government for annual stipend in 2003 and 2004, and the Australian
Acupuncture and Chinese Medicine Association LTD for partial financial support for this
study.
I would like to dedicate this thesis to my parents, Mr. Shiming Guo and Mrs. Huaqin Guo,
and my sisters and brothers, for their continual love and support throughout my schooling
years and always; and to my husband, Dr Henry Liming Liang for his full understanding of
my study and encouragement.

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ABBREVIATIONS
AA Acupuncture analgesia
AE Adverse events
ANOVA Repeated measures analysis of variance
BDI-II Beck Depression Inventory-II
BMA British Medical Association
BMAS British Medical Acupuncture Association
BP SF-36 bodily pain
BWCPM Barbara Walker Centre for Pain Management
CAT Complementary and alternative therapy
CBT Cognitive behavioural therapy
CCT Controlled clinical trials
CF Consent form
CMRB Chinese medicine registration board
CNMP Chronic non-malignant pain
CNS Central nerve system
COX Cyclo-oxygenase
CSF Cerebral spinal fluid
CT Conventional therapy
CTN Clinical Trial Notification
DNIC Diffuse noxious inhibitory controls
DOC Dosage of Opioid Consumed
DSM-IV Mental Disorders-Fourth Edition
Dyn A Dynorphin A
EA Electro-acupuncture
EAA EA analgesia
EI Expression of Interest
EOPs Endogenous opioid peptides
ES Electrical stimulation
fMRI Functional magnetic resonance imaging
GBS Gracely Box Scales
GH SF-36 general health
GLM General Linear Model
GP General practitioner
HREC Human Research Ethics Committees
HRQL Health Related Quality of Life
IASP International Association for the Study of Pain
ITT Intention-to-treat
LOE level of evidence
LR literature review
MD Medical doctors

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MDA Multidisciplinary assessment
MEAP Met-enkephalin-Arg-Phe
MH SF-36 Mental health
MPM Multidisciplinary pain management
MPQ McGill Pain Questionnaire
MQS Medication Quantification Scale
NHMRC The National Health and Medical Research Council
NIH National Institute of Health
NRS Numerical rating scales
NSAIDs Non-steroidal anti-inflammatory drugs
NSW New South Wales
NWC Number of words chosen
OA Osteoarthritis
OLM Opioid-like pain medications
PAG Periaqueductal grey matter
PF SF-36 physical functioning
PI Participant information
PNS Peripheral nervous system
PP Potential participants
PPE Preproenkephalin
PPI Present pain intensity
PRI Pain rating indexes
PRI-a PRI-affective
PRI-e PRI-evaluative
PRI-m PRI-miscellaneous
PRI-s PRI-sensory
PS Potential subjects
PTs Physical therapies
pw post-treatment
PWL paw withdrawal latency
QoL Quality of life
RA Research assistant
RCT Randomised controlled trial
RE SF-36 role emotional
REA Real electro-acupuncture
RP Sf-36 role physical
SD Standard deviations
SEA Sham electro-acupuncture
SF SF-36 social functioning
SF-36 Short Form 36 Health Survey
SPSS Statistical Package for the Social Sciences
SSRI Serotonin-selective reuptake inhibitors
START Selected Targets of Activity ReTraining

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SVH St. Vincent’s Hospital
TAES Transcutaneous acupuncture electrical stimulation
TCAs Tricyclic antidepressants
TENS Transcutaneous electrical nerve stimulation
TGA Therapeutic Goods Administration
tw Treatment week
UK United Kingdom
US United States
VAS Visual Analogue Scale
VT SF-36 vitality
WHO World Health Organization

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RELEVANT CONFERENCE PRESENTATIONS
Guo, R. X. J., Zheng, Z., Xue, C. C., & Helme, R. (2005, June ). Consumption of morphine
like medication in chronic pain patients following electroacupuncture with 2/100 Hz.
Poster presented at Inaugural Research Conference, School of Health Sciences,
RMIT University, Melbourne, Australia.
Guo, R. X. J., Zheng, Z., Xue, C. C., & Helme, R. (2005, May). The efficacy of
electroacupuncture in reducing opioid intake in patients with chronic pain - a pilot
study. Oral presentation at AACMA Annual Conference (47), Melbourne, Australia.
Guo, R. X. J., Zheng, Z., Xue, C. C., & Helme, R. (2005, December). The efficacy of electro-
acupuncture on the consumption of opioid-like medications in chronic pain patients:
a randomised, single blind, sham controlled trial. Poster session presented at the
International Symposium on Harmonisation of Traditional and Modern Medicine,
Melbourne, Australia.
Guo, R. X. J., Zheng, Z., Xue, C. C., & Helme, R. (2003, November). Evaluation of ideal
parameters of electroacupuncture for reducing opioids intake in patients with
postoperative pain – a literature review. Poster session presented at the First
Congress of World Congress on Chinese Medicine, Melbourne, Australia.

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TABLE OF CONTENTS

DECLARATION..............................................................................I

ACKNOWLEDGEMENTS .......................................................... II

ABBREVIATIONS.......................................................................III

RELEVANT CONFERENCE PRESENTATIONS..................VI

SUMMARY.......................................................................................1

CHAPTER ONE: INTRODUCTION............................................4

CHAPTER TWO: LITERATURE REVIEW ..............................8

2.1 Part One - Chronic pain and opioid use............................................................................8
2.1.1 Impact of chronic pain...............................................................................................8
2.1.2 Management of chronic pain....................................................................................10
2.1.3 Measurements of chronic pain and related variables...............................................11
2.1.4 Pharmacotherapy......................................................................................................18
2.1.5 Non-pharmacological treatment approaches............................................................27
2.2 Part Two - Neural mechanisms of electro-acupuncture analgesia..................................33
2.2.1 Neural mechanisms of electro-acupuncture analgesia.............................................33
2.2.2 Endogenous opioid peptides and electro-acupuncture analgesia.............................36
2.2.3 Optimal parameters of electro-acupuncture for analgesia........................................41
2.3 Part Three - A critical review of randomised controlled trials of electro-acupuncture on
consumption of opioid like medication in pain patients.................................................44
2.3.1 Aims.........................................................................................................................44
2.3.2 Methodology............................................................................................................44
2.3.3 Results......................................................................................................................47
2.3.4 Discussion................................................................................................................59
2.3.5 Conclusion...............................................................................................................64
2.4 Part Four - Research aims...............................................................................................64

CHAPTER THREE: METHOD ..................................................65

3.1 Trial design.....................................................................................................................65
3.2 Participants.....................................................................................................................65
3.3 Selection Criteria............................................................................................................65
3.3.1 Inclusion Criteria......................................................................................................65
3.3.2 Exclusion Criteria....................................................................................................66
3.4 Procedure for recruitment...............................................................................................67
3.4.1 Randomisation.........................................................................................................71
3.4.2 Blinding....................................................................................................................71
3.4.3 Drop outs..................................................................................................................72
3.5 Materials and Methods...................................................................................................72
3.5.1 Materials...................................................................................................................72
3.5.2 Real electro-acupuncture treatment..........................................................................73
3.5.3 Sham electro-acupuncture treatment........................................................................75
3.6 Outcome Measures.........................................................................................................78
3.6.1 Primary Outcome Measures.....................................................................................78
3.6.2 Secondary Outcome Measures.................................................................................81
3.7 Procedure of the study....................................................................................................82
3.7.1 Initial examination and assessment..........................................................................82
3.7.2 Baseline stage...........................................................................................................83
3.7.3 Treatment stage........................................................................................................84

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3.7.4 Follow up stage........................................................................................................84
3.7.5 Telephone consultation............................................................................................84
3.7.6 Sample size calculation............................................................................................86
3.8 Data collection and analysis...........................................................................................87
3.8.1 Data collection.........................................................................................................87
3.8.2 Data analysis............................................................................................................87

CHAPTER FOUR: SHORT TERM EFFECTS OF ELECTRO-
ACUPUNCTURE ON OPIOID MEDICATION
CONSUMPTION, PAIN AND RELATED VARIABLES.........90

4.1 Allocation of participants...............................................................................................90
4.2 Socio-demographic data.................................................................................................93
4.3 Classifications of diagnosis in Western Medicine..........................................................95
4.4 Baseline clinical characteristics......................................................................................99
4.4.1 Clinical characteristics at baseline...........................................................................99
4.4.2 Side effects of opioid like medication at baseline..................................................101
4.5 The effects of EA on the primary outcomes during the treatment period....................104
4.5.1 Dosages of opioid like medication consumption...................................................104
4.5.2 Side effects of opioid like medication....................................................................105
4.5.3 The effects of EA on the intensity and unpleasantness of pain..............................108
4.6 The effects of EA on secondary outcomes during the treatment period.......................113
4.6.1 Severity of depression............................................................................................113
4.6.2 Quality of life (SF-36 Health survey)....................................................................113
4.6.3 Non-opioid analgesics assessed with MQS............................................................114
4.7 Summary.......................................................................................................................116
4.8 Adverse events of EA...................................................................................................117
4.9 Credibility of blinding process.....................................................................................117

CHAPTER FIVE: LONG TERM EFFECTS OF ELECTRO-
ACUPUNCTURE ON OPIOID LIKE MEDICATION
CONSUMPTION, PAIN AND RELATED VARIABLES...... 119

5.1 The effects of EA on the primary outcomes during the follow-up period....................119
5.1.1 Dosages of opioid like medication consumption...................................................119
5.1.2 Side effects of opioid like medication....................................................................120
5.1.3 The effects of EA on the intensity and unpleasantness of pain..............................122
5.2 The effects of EA on secondary outcomes during the follow-up period......................123
5.2.1 Severity of depression............................................................................................123
5.2.2 Quality of life (SF-36 Health survey)....................................................................123
5.3 Summary.......................................................................................................................124

CHAPTER SIX: DISCUSSION................................................. 125

6.1 Population sample.........................................................................................................125
6.2 Credible sham EA design.............................................................................................126
6.3 Short and long term effects of electro-acupuncture on OLM reduction.......................127
6.3.1 The short term effect of EA on OLM consumption...............................................128
6.3.2 The long term effects of REA on OLM consumption............................................131
6.4 The effects of EA on OLM related-side effects............................................................133
6.5 The effects of EA on pain intensity..............................................................................134
6.6 The effects of EA on depression and QoL....................................................................136

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