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Electroanalgesia: Historical and Contelllporary Developlllents Electroanalgesia: Historical and Contelllporary Developlllents PhD Thesis (VoluDle II) 1998 Joseph Gordon Gadsby BA(Hons) RGN RMN DipN(Lond) MISBM DHP DHS Department of Biological Sciences School of Applied Sciences De Montfort University Leicester Electroanalgesia: Historical and Conte:mporary Developntents A Thesis in Partial Fulfilntent of the Degree of Doctor of Philosophy Volume II Sections 7-8 Summary of Thesis Contents Title: Electroanalgesia: Historical and Contemporary Development Abstract: Acknowledgements: Contents list: Glossary: 1. Summary 2. Introduction 3. Historical and Experimental Studies 3.1 Introduction to the first stage of the study programme: historical developments in electro analgesia, mechanisms of electroanalgesia and clinical research 3.2 Early developments in electro analgesia 3.3 The Rev. John Wesley MA (1703-1791) Pioneer Electrotherapist: A History of Medicine Study 3.4 Mechanisms of pain 3.5 Mechanisms of electrical pain relief 3.6 Clinical Research - A randomised controlled trial of electroanalgesia in palliative medicine using acupuncture-like transcutaneous electrical nerve stimulation: A pilot study 3.7 Conclusions and recommendations 4.Tertiary Research: Systematic reviews and meta-analysis: 4.1 Introduction to the second stage of the study programme: systematic reviews and meta-analysis 4.2 Systematic reviews, meta-analysis and the Cochrane Collaboration 4.3 Developing a protocol for a Cochrane systematic review 4.4 Developing a Cochrane systematic review and meta-analysis 4.5 The effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for chronic low back pain - A Cochrane Library Review 4.6 Improving and updating systematic reviews using the Cochrane Collaboration comments and criticisms mechanism 4.7 Conclusions and recommendations 5. Conclusions and the Contribution to Knowledge An evaluation of the contribution this study makes to our knowledge base 6. Bibliography: References and Background Reading 7. Appendix A: Clinical Research: (i)Research Manual; (ii) Ethics Application Form; (iii) Poster Presentation and Abstract; (iv) Transfer of Registration Document. 8. Appendix B: Tertiary Research: (i) Cochrane Collaboration Documents; (ii)Data Collection; (iii) Quality Documents; (iv) Sensitivity Documents; (v) Amended Cochrane Glossary. Electroana lgesia : Tertia ry Research : System a tic Reviews a nd Meta-a n alysis APPENDIX A (Clinical Research) Electroa n a lgesia : Te rtia ry Researc h : Sys tem a tic Review s a nd Meta-an a lys is APPENDIX Ai (i) Research Manual for 3.5 The Leicestershire Hospice & The De ·Montfort University Leicester Research Manual November 1994 378 INDEX 1. Title.••••••••••.••••••••••••••••••.••••••••••••••••••.•••••••••••••••••••••••••••••••••••••••••.•••••.•••.••••••••••••••• 3 2. Personnel identification ••.••...••...••...•..•••••.•....••...••....•..••••••••..•••.••••.•••.•••••.•...•••.•• 3 3. Objectives: ••..••••.•••.•..••.••.••••.••...•••..••......•.•...•••...••...••.••••...••..•...••••.••...••••..••...•.•• 3 4. Rationale: .....•............•...........•...•....•..........•.............•...•.•....•...•.....•.••..•..........••... 4 5. Design: ••.•••••••••••.•••••••••.•••.•••.••••••••••.••••••••••••.•••••••••.•••.••••••••••.•••.••••••••••••••••••••••.••• 5 6. Patient selection: ••..•..•...•...•...••...•........••.....•..•.......•....•....•........•...•...........••......... 6 7. Methodology: .•.••••.•.•...•...•.•.••••••.••••••••••••••••••••••.•••.•••.•....••..•..••.•.•........•••••.•..••.•••. 6 8. Responsibilities: •••••••••••••••••••••••••••••••••••••••••••••••.•••••••.•••••••.••••••••••••••••••••.••••••••...•• 8 9. Statistical considerations: •••••••••..•..••••.....••.•••..••••••••••••••.•••.••••••••••.•••.•••••••.•••••••.•• 8 11. References & Bibliography: ....••...•.....•..••.•..••.•.•.••..•.•..••••..•...••...•••..•..•...•...•.••••. 9 12. Appendices: .•••••••••••••••••..•••••••.••••.•••.••••..•••..•••...•.•••••••.••••••.•••••••••••••...•••.••.•••••••• 11 13. Patient information leaflet: .•..••..•••..••.............••....•..•••.•••...•.•.••••..••..••••.•••••..•••.. 15 14. Consent form: .••••••••..••.••••.••..•••••••.•••••••.•••••••••••••••••••••••••.•.•••••••••••••...•••.•••••••••.•• 16 15. Data sheets: •••.•••••••••.•••.•••.••••.•••••.••••••••••••••••••.•••••••••••••••••..•••••••••••••..•••.•..•••..••••• 17 379 1. Title: Acupuncture -like Transcutaneous Electrical Nerve Stimulation (AL TENS) as an adjuvant therapy within Palliative Medicine. 2. Personnel identification: Dr Ian Johnson: Consultant in Palliative MedicinelIndependent Assessor; The Leicestershire Hospice: Tel: (0533) 31377l. Mr Gordon Gadsby: Nurse PractitionerlPost Graduate Researcher. 47 Milton Crescent, Leicester: Tel: (0533) 352204. Dr Frank Dewhurst: Principal LecturerlDirector of Studies; Dept of Applied Biology and Biotechnology. De Montfort University. Leicester: Tel: (0533) 577730: Dr Alison Franks: Senior Registrar in Palliative Medicine The Leicestershire Hospice: Tel (0533) 313771 Mr Philip Jarvis: Senior Lecturer in Statistics: Dept of Mathematical Sciences. De Montfort University. Tel: (0533) 551551 x8481 3. Aims and Objectives: Aim • To determine if there is a role for acupuncture-like transcutaneous electrical nerve stimulation (AL TENS) in improving the quality of care within palliative medicine. Objectives • To assess the effectiveness of this non-invasive therapy as an antiemetic and analgesic as an adjunct to conventional care, • To record biophysical measurements of electrical resistance in cancer patients and to compare with measurements in non-cancer controls. • To assess the usefulness of these measurements of electrical resistance as a diagnostic and therapeutic indicator in palliative medicine. 380 4. Rationale: a. acupuncture and electrostimulation in palliative medicine: The study originated following informal discussions between IJ and GG and their mutual interest in acupuncture and related therapies in relation to antiemesis and analgesia. A considerable amount of work on anti-emesis using acupuncture and electrical stimulation has recently been conducted by, amongst others, the late Prof John Dundee and his team (1984-1992), which demonstrated a significant anti emesis benefit within post-operative sickness, morning sickness of pregnancy and cancer chemotherapy sickness. There are also numerous studies on pain relief within musculo­ skeletal and neurological systems (see Richardson & Vincent's 1986 review), using acupuncture and electro stimulation techniques but there is little documentation available to support its application within palliative medicine. There would appear to be few ethical objections to this treatment since it is known to be very safe with few contraindications and because of its intended use as an adjuvant therapy to conventional antiemetic and analgesic medications. It is anticipated that the application of this treatment will enhance the effectiveness of both conventional anti emetics and analgesics, with an expected reduction in their usage. b. biophysical measurements: On the basis of a large sample of biophysical electrical measurements recorded by members of The Society of Biophysical Medicine, it has been found that patients in good health show hand to hand and foot to foot resistance measurements of20-30 kilohm and 40-50 kilohm respectively (ISBM 1984). These measurements are the cornerstone investigations of medical and paramedical practitioners of Biophysical Medicine (ISBM) and members of the Society of Electrotherapists (SET). Lower than average values are typically found in inflammatory conditions and higher values in degenerative conditions. It is characteristic of this measurement scale that people who are ill show readings which are a long way from the normal range. It is proposed that these non-invasive biophysical measurements of electrical resistance are taken during this trial, pre and post treatment, using a standard multimeter to record hand to hand and foot to foot electrical resistance in kilohms, in order to make a comparison between advanced stage cancer patients and the average normal readings described above. It is predicted that the electrical resistance measurements of terminal patients will be significantly higher than normal and their usefulness as a diagnostic and therapeutic indicator may then be assessed. This has not previously been carried out by other researchers. 381 5. Design: The double-blind condition cannot easily be maintained in trials of physical treatments, and trials of acupuncture are often single blind design. (Vincent 1989, Dundee et al 1992). However, the present study is designed to fulfil double-blind criteria as far as possible and employs a control condition which should be seen as a credible, bona fide treatment by patients. The treatment under study will be acupuncture-like transcutaneous nerve stimulation (ALTENS) given as an adjuvant to the recognised standard techniques for pain and anti emesis. Patients will be randomly allocated to receive standard treatment only, standard + ALTENS or standard + placebo. The placebo therapy will be a fully functional transcutaneous nerve stimulation (TENS) unit with flashing frequency LED's using the same apparatus type as the real therapy under investigation, but with non-functioning output leads. The full range of biophysical measurements of electrical resistance will also be recorded pre and post treatment to enhance the credibility of the placebo. Randomisation is by the sealed envelope technique in conjunction with random
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