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Neuromodulatie bij chronische pijn / Cécile Camberlin / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2012)
Neuromodulatie bij chronische pijn : ingeplante ruggenmerg stimulatoren en pompen voor de intrathecale toediening van analgetica [printed text] / Cécile Camberlin , Author ; Lorena San Miguel , Author ; Yolba Smit, Author ; Piet Post, Author ; Sophie Gerkens , Author ; Chris De Laet , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2012 . - VII, 253 p. : Ill. ; A4. - (KCE Reports A. Health Technology Assessment (HTA); 189A) .
ISSN : D/2012/10.273/74 : € 0,00
Studie 2010-13 HTA Spinal Cord Stimulation
Languages : English (eng) Dutch (nla)
Descriptors: Indexation
2010-13 ; Chronic Pain ; Electric Stimulation Therapy ; Infusion Pumps, Implantable ; Pain ; Pain, Intractable ; prevention and control ; R189
Classification
WL 704.6 Pain managementAbstract: Het Federaal Kenniscentrum voor de Gezondheidszorg (KCE) bestudeerde ruggenmergstimulatie en pijnpompen (IADP), twee types van neuromodulatie voor het bestrijden van ernstige chronische pijn. Het wetenschappelijke bewijs van hun werkzaamheid is beperkt, en zoals bij elke invasieve ingreep zijn er risico’s. Daarom worden deze ingrepen best uitgevoerd als geen enkele andere therapie nog helpt. Opvallend is ook het hoge aantal neuromodulatie ingrepen in België, vergeleken met de buurlanden. Een mogelijke verklaring hiervoor zijn de vele rugoperaties in ons land. Contents note: SYNTHESE 18 -- 1. DOEL EN SCOPE 18 -- 2. CHRONISCHE PIJN EN PIJNBESTRIJDING 19 -- 2.1. HOE PIJN DEFINIËREN EN METEN? 19 -- 2.2. NOCICEPTIEVE VERSUS NEUROPATHISCHE PIJN 19 -- 2.3. CHRONISCHE PIJN 19 -- 2.4. BESTRIJDING VAN CHRONISCHE PIJN 19 -- 3. NEUROMODULATIETECHNIEKEN 20 -- 4. DE MEEST GANGBARE INDICATIES 21 -- 5. DOELTREFFENDHEID EN VEILIGHEID 22 -- 5.1. BEPERKTE EVIDENCE VOOR DOELTREFFENDHEID 22 -- 5.2. VEILIGHEID 23 -- 5.3. CONCLUSIE 23 -- 6. ECONOMISCHE EVALUATIE 23 -- 7. REGLEMENTERING EN TERUGBETALING 24 -- 7.1. INDICATIES 24 -- 7.2. DUUR VAN DE TESTPERIODE 24 -- 7.3. KEUZE VAN HET IMPLANTAAT 24 -- 8. GEBRUIK EN KOSTEN 25 -- 8.1. DATA 25 -- 8.2. INGEPLANTE SYSTEMEN 25 -- 8.3. PATIËNTEN EN INDICATIES 25 -- 8.4. LEVENSDUUR VAN DE BATTERIJEN 26 -- 9. CONCLUSIE 26 -- SCIENTIFIC REPORT 28 -- SCOPE OF THIS REPORT 28 -- 1. CHRONIC PAIN AND ITS MANAGEMENT 29 -- 1.1. INTRODUCTION 29 -- 1.2. GENERAL DEFINITION OF PAIN 29 -- 1.3. SPECIFIC DEFINITIONS OF PAIN 30 -- 1.3.1. Nociceptive pain 30 -- 1.3.2. Neuropathic pain 30 -- 1.3.3. Paraesthesia 30 -- 1.3.4. Pain threshold and pain tolerance 30 -- 1.4. DURATION OF PAIN 31 -- 1.5. EPIDEMIOLOGY OF PAIN 31 -- 1.6. DIAGNOSIS AND MEASUREMENT OF PAIN 31 -- 1.7. MANAGEMENT OF CHRONIC PAIN 32 -- 1.8. PAIN MANAGEMENT FACILITIES 32 -- 1.8.1. Multidisciplinary pain centres 32 -- 1.8.2. Other forms of pain centres 33 -- 1.9. THE MOST COMMON INDICATIONS FOR NEUROMODULATION 33 -- 1.9.1. Failed back surgery syndrome (FBSS) 33 -- 1.9.2. Complex regional pain syndrome (CRPS) 33 -- 1.9.3. Critical limb ischemia (CLI) 33 -- 1.9.4. Refractory angina pectoris (AP) 33 -- 1.9.5. Refractory cancer pain 34 -- 2. NEUROMODULATION TECHNIQUES 34 -- 2.1. DEFINITION OF NEUROMODULATION AND SCOPE OF THIS REPORT 34 -- 2.1. SCS TECHNOLOGY 35 -- 2.1.1. Definition of SCS 35 -- 2.1.2. History of SCS 35 -- 2.1.3. Mechanism of SCS action 36 -- 2.1.4. Claimed advantages of SCS 37 -- 2.1.5. Disadvantages of SCS 37 -- 2.1.6. The SCS system 37 -- 2.1.7. SCS procedures 38 -- 2.2. IADP TECHNOLOGY 39 -- 2.2.1. Definition of IADP 39 -- 2.2.2. History of IADP 39 -- 2.2.3. Mechanism of IADP action 39 -- 2.2.4. Claimed advantages of IADP 40 -- 2.2.5. Disadvantages of IADP 40 -- 2.2.6. The IADP system 40 -- 2.2.7. IADP procedures 41 -- 3. EFFECTIVENESS AND SAFETY 41 -- 3.1. INTRODUCTION 41 -- 3.2. METHODS 41 -- 3.2.1. Types of studies 41 -- 3.2.2. Patients included 41 -- 3.2.3. Types of interventions 41 -- 3.2.4. Types of outcome measures 42 -- 3.2.5. Search strategy for the systematic literature review 42 -- 3.2.6. Reference tracking 42 -- 3.2.7. Data collection and analysis 42 -- 3.3. RESULTS 43 -- 3.3.1. Overview of the search and selection process 43 -- 3.3.2. Spinal cord stimulation in patients with failed back surgery syndrome (FBSS) 44 -- 3.3.3. Spinal cord stimulation in patients with complex regional pain syndrome (CRPS) 45 -- 3.3.4. Spinal cord stimulation in patients with diabetic neuropathy 46 -- 3.3.5. Spinal cord stimulation in patients with critical limb ischemia (CLI) 46 -- 3.3.6. Spinal cord stimulation in patients with refractory angina pectoris (RAP) 48 -- 3.3.7. Intrathecal Analgesic Delivery Pumps 50 -- 3.4. ONGOING CLINICAL TRIALS 51 -- 3.5. DISCUSSION 52 -- 3.5.1. Evidence from interventional research 52 -- 3.5.2. Safety issues 53 -- 3.5.3. Evidence from observational research 53 -- 3.5.4. Conclusion. 53 -- 3.6. KEY POINTS 54 -- 4. ECONOMIC EVALUATION 55 -- 4.1. INTRODUCTION 55 -- 4.2. METHODS 55 -- 4.2.1. Search strategy 55 -- 4.2.2. Selection procedure 55 -- 4.2.3. Selection criteria 55 -- 4.3. RESULTS 55 -- 4.3.1. Overview of the search and selection process 55 -- 4.3.2. Study design 58 -- 4.3.3. Type of economic evaluation 58 -- 4.3.4. Time frame of analysis 58 -- 4.3.5. Discounting 58 -- 4.3.6. Perspective 59 -- 4.3.7. Population size 59 -- 4.3.8. Indications and comparators 59 -- 4.3.9. Overview of costs and outcomes 65 -- 4.3.10. Sensitivity analysis 67 -- 4.3.11. Battery life 67 -- 4.4. DISCUSSION 68 -- 4.4.1. Spinal cord stimulation 68 -- 4.4.2. Intrathecal analgesic delivery pumps 70 -- 4.5. KEY POINTS 70 -- 5. BELGIAN REGULATION FOR REIMBURSEMENT 71 -- 5.1. OVERALL LEGAL FRAMEWORK FOR REIMBURSEMENT OF MEDICAL ACTS 71 -- 5.2. LEGAL FRAMEWORK FOR IMPLANTABLE DEVICES 71 -- 5.3. REIMBURSEMENT MODALITIES FOR IMPLANTABLE DEVICES 71 -- 5.4. IMPLANTS CONCERNED BY THIS HTA 71 -- 5.4.1. Lists of implants accepted for reimbursement (‘limitative lists’) 71 -- 5.4.2. Warranty periods 72 -- 5.5. APPROVED INDICATIONS, DEVICES AND REGULATIONS 72 -- 5.6. PRESCRIBERS AND IMPLANTERS 72 -- 5.7. IMPLANT SUPPLIERS AND THE DELIVERY MARGIN 72 -- 5.8. APPROVED IMPLANTING CENTRES 73 -- 5.9. TRIAL PERIOD 73 -- 5.10. DRUGS APPROVED FOR INTRATHECAL ADMINISTRATION 73 -- 5.11. REQUEST FOR REIMBURSEMENT 73 -- 5.12. MEDICAL ACTS RELEVANT TO THIS HTA 74 -- 5.13. MULTIDISCIPLINARY TEAMS FOR PAIN MANAGEMENT 74 -- 5.14. ORGANISATION OF PAIN CENTRES 75 -- 5.15. SCIENTIFIC PAIN SOCIETIES 75 -- 5.16. KEY POINTS 76 -- 6. REGULATIONS FOR REIMBURSEMENT IN NEIGHBOURING COUNTRIES 76 -- 6.1. INTRODUCTION 76 -- 6.2. FRANCE 76 -- 6.2.1. Overall legal framework for reimbursement 76 -- 6.2.2. Legal framework and reimbursement modalities for implantable devices 77 -- 6.2.3. SCS reimbursement criteria 77 -- 6.2.4. IADP reimbursement criteria 78 -- 6.2.5. Number of procedures performed 79 -- 6.3. THE NETHERLANDS 79 -- 6.3.1. Overall legal framework for reimbursement 79 -- 6.3.2. Legal framework and reimbursement modalities for implantable devices 80 -- 6.3.3. SCS reimbursement criteria 80 -- 6.3.4. IADP reimbursement criteria 81 -- 6.3.5. Number of procedures performed 81 -- 6.4. GERMANY 81 -- 6.4.1. Overall legal framework for reimbursement 81 -- 6.4.2. Legal framework and reimbursement modalities for implantable devices 82 -- 6.4.3. SCS reimbursement criteria 83 -- 6.4.4. IADP reimbursement criteria 84 -- 6.4.5. Number of procedures performed 84 -- 6.5. UK 84 -- 6.5.1. Overall legal framework for reimbursement 84 -- 6.5.2. Legal framework and reimbursement modalities for implantable devices 84 -- 6.5.3. SCS reimbursement criteria 85 -- 6.5.4. IADP reimbursement criteria 86 -- 6.5.5. Number of procedures performed 86 -- 6.6. DISCUSSION 87 -- 6.6.1. Overview of the situation in different countries 87 -- 6.6.2. Approved indications 91 -- 6.6.3. Prescription and use modalities 91 -- 6.6.4. Number of procedures 92 -- 6.6.5. Conclusion. 92 -- 6.7. KEY POINTS 92 -- 7. NEUROMODULATION USE IN BELGIUM 93 -- 7.1. METHODOLOGY 93 -- 7.1.1. Description of the Belgian administrative databases used 93 -- 7.1.2. Data extraction 93 -- 7.1.3. Analysis 94 -- 7.2. IMPLANTED SYSTEMS: NUMBER, COST AND GEOGRAPHY 95 -- 7.2.1. Under- and over-reporting in the data 95 -- 7.2.2. Volumes and device expenses 95 -- 7.2.3. Geography of implants 96 -- 7.2.4. Geography of patients 97 -- 7.2.5. Total hospitalization cost per implant 98 -- 7.2.6. Yearly cost of neuromodulation implants in Belgium 99 -- 7.3. PATIENT CHARACTERISTICS 99 -- 7.3.1. Age and gender 99 -- 7.3.2. Chronology of implants 101 -- 7.3.3. Hospital diagnoses 101 -- 7.4. INDICATIONS IN PRACTICE 102 -- 7.4.1. Expert opinion 102 -- 7.4.2. Data analysis 102 -- 7.4.3. Back surgery in Belgium 103 -- 7.5. DEVICE SURVIVAL 104 -- 7.5.1. Data and methods 104 -- 7.5.2. Analysis 1: Base case scenario 2002-2008 105 -- 7.5.3. Analysis 2: Scenario with censoring only at date of last discharge 2002-2008 105 -- 7.5.4. Analysis 3: Scenario with censoring only at end of follow-up period if no dead was recorded previously 2002-2008 106 -- 7.5.5. Analysis 4: Scenario as in analysis 3 but without censoring at date of implantation of another type of device 2002-2008 107 -- 7.5.6. Analyses 5 to 8 (2006-2008) 108 -- 7.6. DISCUSSION 109 -- 7.7. KEY POINTS 110 -- APPENDICES 111 -- 1. APPENDIX TO CHAPTER ON CHRONIC PAIN 111 -- 1.1. OVERVIEW OF IASP PAIN DEFINITIONS 111 -- 2. APPENDIX TO CHAPTER ON NEUROMODULATION TECHNOLOGY 113 -- 2.1. OVERVIEW OF CONDITIONS AND THERAPIES COMMONLY ASSOCIATED WITH NEUROMODULATION 113 -- 3. APPENDIX TO CHAPTER ON EFFECTIVENESS AND SAFETY 114 -- 3.1. INTRODUCTION 114 -- 3.2. SEARCH STRATEGIES SYSTEMATIC LITERATURE REVIEW 114 -- 3.2.1. Pubmed through Medline 114 -- 3.2.2. EMBASE through OVID® 115 -- 3.2.3. Other searches 118 -- 3.2.4. Cochrane Central Register of Controlled Trials (CENTRAL) 118 -- 3.3. EVIDENCE FROM INTERVENTIONAL STUDIES 120 -- 3.3.1. Overview of systematic reviews and selected RCTs 120 -- 3.3.2. Assessment of methodological quality 127 -- 3.3.3. Evidence and GRADE tables 128 -- 3.4. ADDITIONAL SEARCHES FOR NON-INTERVENTIONAL EVIDENCE 156 -- 3.4.1. Additional searches in Pubmed using Medline 156 -- 3.4.2. Hand searching of four selected journals 156 -- 3.4.3. Update search through Cochrane Library 156 -- 3.4.4. Removal of duplicates 156 -- 4. APPENDIX TO CHAPTER ON ECONOMIC EVALUATION 157 -- 4.1. SEARCH STRATEGIES 157 -- 4.2. 160 -- 4.3. LITERATURE SELECTION PROCESS 161 -- 4.3.1. Spinal cord stimulation for FBSS 162 -- 4.3.2. Spinal cord stimulation for CRPS 164 -- 4.3.3. Spinal cord stimulation for critical limb ischemia 165 -- 4.3.4. Spinal cord stimulation for angina pectoris 166 -- 4.3.5. Intrathecal analgesic delivery pumps for FBSS 167 -- 4.4. DATA EXTRACTION TABLES – SCS 168 -- 4.5. DATA EXTRACTION TABLES – IADP 198 -- 5. APPENDIX TO CHAPTER ON BELGIAN REGULATION FOR REIMBURSEMENT. 203 -- 5.1. OVERALL LEGAL FRAMEWORK FOR REIMBURSEMENT OF MEDICAL ACTS 203 -- 5.2. LEGAL FRAMEWORK FOR IMPLANTABLE DEVICES 203 -- 5.2.1. Definition of an implant 203 -- 5.2.2. Belgian categories of implantable devices 203 -- 5.2.3. European classification of medical devices 204 -- 5.3. IMPLANTS CONCERNED BY THIS HTA 204 -- 5.3.1. Implants by category 204 -- 5.3.2. Description and structure of the limitative lists 206 -- 5.3.3. Warranty periods 208 -- 5.4. APPROVED INDICATIONS, DEVICES AND REGULATIONS 208 -- 5.4.1. Neurogenic pain syndromes 208 -- 5.4.2. Thromboangiitis obliterans 208 -- 5.4.3. Chronic pancreatitis 209 -- 5.4.4. Critical lower limb ischemia 209 -- 5.4.5. Rechargeable neurostimulator 209 -- 5.5. IMPLANT SUPPLIERS AND THE DELIVERY MARGIN 209 -- 5.5.1. National agreement 209 -- 5.5.2. The delivery margin 210 -- 5.6. APPROVED IMPLANTING CENTRES 210 -- 5.7. TRIAL PERIOD 210 -- 5.8. REQUEST FOR REIMBURSEMENT 210 -- 5.8.1. Requirement of a multidisciplinary team 210 -- 5.8.2. Contents of medical report 211 -- 5.9. MEDICAL ACTS RELEVANT TO THIS HTA 212 -- 5.10. MULTIDISCIPLINARY TEAMS FOR PAIN MANAGEMENT 214 -- 5.11. BELGIAN REFERRAL CENTRES FOR CHRONIC PAIN 214 -- 6. APPENDIX TO CHAPTER ON REGULATIONS FOR REIMBURSEMENT IN NEIGHBOURING COUNTRIES 215 -- 6.1. FRANCE 215 -- 6.2. THE NETHERLANDS 216 -- 6.3. GERMANY 217 -- 6.4. UK 218 -- 7. APPENDIX TO CHAPTER ON NEUROMODULATION USE IN BELGIUM 219 -- 7.1. METHODOLOGY 219 -- 7.2. DESCRIPTIVE ANALYSES 219 -- 7.2.1. Baseline data 219 -- 7.2.2. Under- and over-reporting in the data 222 -- 7.2.3. Patient characteristics 223 -- 7.2.4. Hospitalization Diagnoses 224 -- 7.2.5. Implants Geography 232 -- 7.2.6. Number of implants per hospital 234 -- 7.2.7. Patient chronology 234 -- 7.3. DEVICE SURVIVAL 235 -- 7.4. HOSPITALIZATION COSTS PER IMPLANT 238 -- 7.4.1. Data cleaning 238 -- 7.4.2. Reconstruction of the part of the hospital financing related to an hospitalization stay in particular 238 -- 7.4.3. Scenarios 238 -- 7.4.4. Results 238 -- REFERENCES 243 Link for e-copy: https://doi.org/10.57598/R189A Format of e-copy: PDF (2 MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=3096 Copies(0)
Status No copy Neuromodulatie bij chronische pijn / Cécile Camberlin / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2012)
Neuromodulatie bij chronische pijn : ingeplante ruggenmerg stimulatoren en pompen voor de intrathecale toediening van analgetica - Synthese [printed text] / Cécile Camberlin , Author ; Lorena San Miguel , Author ; Yolba Smit, Author ; Piet Post, Author ; Sophie Gerkens , Author ; Chris De Laet , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2012 . - 14 p. : Ill. ; A4. - (KCE Reports A. Health Technology Assessment (HTA); 189As) .
ISSN : D/2012/10273/77 : € 0,00
Studie 2010-13 HTA Spinal Cord Stimulation
Languages : Dutch (nla)
Descriptors: Indexation
2010-13 ; Chronic Pain ; Electric Stimulation Therapy ; Infusion Pumps, Implantable ; Pain ; Pain, Intractable ; prevention and control ; R189
Classification
WL 704.6 Pain managementAbstract: Het Federaal Kenniscentrum voor de Gezondheidszorg (KCE) bestudeerde ruggenmergstimulatie en pijnpompen (IADP), twee types van neuromodulatie voor het bestrijden van ernstige chronische pijn. Het wetenschappelijke bewijs van hun werkzaamheid is beperkt, en zoals bij elke invasieve ingreep zijn er risico’s. Daarom worden deze ingrepen best uitgevoerd als geen enkele andere therapie nog helpt. Opvallend is ook het hoge aantal neuromodulatie ingrepen in België, vergeleken met de buurlanden. Een mogelijke verklaring hiervoor zijn de vele rugoperaties in ons land. Link for e-copy: https://doi.org/10.57598/R189AS Format of e-copy: PDF (244 KB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=3097 Copies(0)
Status No copy Neuromodulation for the management of chronic pain / Cécile Camberlin / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2012)
Neuromodulation for the management of chronic pain : implanted spinal cord stimulators and intrathecal analgesic delivery pumps [printed text] / Cécile Camberlin , Author ; Lorena San Miguel , Author ; Yolba Smit, Author ; Piet Post, Author ; Sophie Gerkens , Author ; Chris De Laet , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2012 . - VI, 258 p. : Ill. ; A4. - (KCE Reports. Health Technology Assessment (HTA); 189C) .
ISSN : D/2012/10.273/76 : € 0,00
Study 2010-13 HTA Spinal Cord Stimulation
Languages : English (eng)
Descriptors: Indexation
2010-13 ; Chronic Pain ; Electric Stimulation Therapy ; Infusion Pumps, Implantable ; Pain ; Pain, Intractable ; prevention and control ; R189
Classification
WL 704.6 Pain managementContents note: SYNTHESIS 18 -- 1. OBJECTIVE AND SCOPE 18 -- 2. CHRONIC PAIN AND ITS MANAGEMENT 19 -- 2.1. HOW TO DEFINE AND MEASURE PAIN? 19 -- 2.2. NOCICEPTIVE VERSUS NEUROPATHIC PAIN 19 -- 2.3. CHRONIC PAIN 19 -- 2.4. CHRONIC PAIN MANAGEMENT 20 -- 3. NEUROMODULATION TECHNIQUES 20 -- 4. THE MOST COMMON INDICATIONS 21 -- 5. EFFECTIVENESS AND SAFETY 22 -- 5.1. LIMITED EVIDENCE OF EFFECTIVENESS 22 -- 5.2. SAFETY ISSUES 22 -- 5.3. CONCLUSION, 22 -- 6. ECONOMIC EVALUATION 23 -- 7. REGULATIONS AND REIMBURSEMENT 23 -- 7.1. INDICATIONS 23 -- 7.2. LENGTH OF TRIAL PERIOD 24 -- 7.3. CHOICE OF IMPLANT 24 -- 8. CURRENT USE AND COSTS 24 -- 8.1. DATA 24 -- 8.2. IMPLANTED SYSTEMS 24 -- 8.3. PATIENTS AND INDICATIONS 25 -- 8.4. BATTERY LIFETIME 25 -- 9. CONCLUSION 26 -- SCIENTIFIC REPORT 27 -- SCOPE OF THIS REPORT 27 -- 1. CHRONIC PAIN AND ITS MANAGEMENT 28 -- 1.1. INTRODUCTION 28 -- 1.2. GENERAL DEFINITION OF PAIN 28 -- 1.3. SPECIFIC DEFINITIONS OF PAIN 29 -- 1.3.1. Nociceptive pain 29 -- 1.3.2. Neuropathic pain 29 -- 1.3.3. Paraesthesia 29 -- 1.3.4. Pain threshold and pain tolerance 29 -- 1.4. DURATION OF PAIN 30 -- 1.5. EPIDEMIOLOGY OF PAIN 30 -- 1.6. DIAGNOSIS AND MEASUREMENT OF PAIN 30 -- 1.7. MANAGEMENT OF CHRONIC PAIN 31 -- 1.8. PAIN MANAGEMENT FACILITIES 31 -- 1.8.1. Multidisciplinary pain centres 31 -- 1.8.2. Other forms of pain centres 32 -- 1.9. THE MOST COMMON INDICATIONS FOR NEUROMODULATION 32 -- 1.9.1. Failed back surgery syndrome (FBSS) 32 -- 1.9.2. Complex regional pain syndrome (CRPS) 32 -- 1.9.3. Critical limb ischemia (CLI) 32 -- 1.9.4. Refractory angina pectoris (AP) 32 -- 1.9.5. Refractory cancer pain 33 -- 2. NEUROMODULATION TECHNIQUES 33 -- 2.1. DEFINITION OF NEUROMODULATION AND SCOPE OF THIS REPORT 33 -- 2.1. SCS TECHNOLOGY 34 -- 2.1.1. Definition of SCS 34 -- 2.1.2. History of SCS 34 -- 2.1.3. Mechanism of SCS action 35 -- 2.1.4. Claimed advantages of SCS 36 -- 2.1.5. Disadvantages of SCS 36 -- 2.1.6. The SCS system 36 -- 2.1.7. SCS procedures 37 -- 2.2. IADP TECHNOLOGY 38 -- 2.2.1. Definition of IADP 38 -- 2.2.2. History of IADP 38 -- 2.2.3. Mechanism of IADP action 38 -- 2.2.4. Claimed advantages of IADP 39 -- 2.2.5. Disadvantages of IADP 39 -- 2.2.6. The IADP system 39 -- 2.2.7. IADP procedures 40 -- 3. EFFECTIVENESS AND SAFETY 40 -- 3.1. INTRODUCTION 40 -- 3.2. METHODS 40 -- 3.2.1. Types of studies 40 -- 3.2.2. Patients included 40 -- 3.2.3. Types of interventions 40 -- 3.2.4. Types of outcome measures 41 -- 3.2.5. Search strategy for the systematic literature review 41 -- 3.2.6. Reference tracking 41 -- 3.2.7. Data collection and analysis 41 -- 3.3. RESULTS 42 -- 3.3.1. Overview of the search and selection process 42 -- 3.3.2. Spinal cord stimulation in patients with failed back surgery syndrome (FBSS) 43 -- 3.3.3. Spinal cord stimulation in patients with complex regional pain syndrome (CRPS) 44 -- 3.3.4. Spinal cord stimulation in patients with diabetic neuropathy 45 -- 3.3.5. Spinal cord stimulation in patients with critical limb ischemia (CLI) 45 -- 3.3.6. Spinal cord stimulation in patients with refractory angina pectoris (RAP) 47 -- 3.3.7. Intrathecal Analgesic Delivery Pumps 49 -- 3.4. ONGOING CLINICAL TRIALS 50 -- 3.5. DISCUSSION 51 -- 3.5.1. Evidence from interventional research 51 -- 3.5.2. Safety issues 52 -- 3.5.3. Evidence from observational research 52 -- 3.5.4. Conclusion. 52 -- 3.6. KEY POINTS 53 -- 4. ECONOMIC EVALUATION 54 -- 4.1. INTRODUCTION 54 -- 4.2. METHODS 54 -- 4.2.1. Search strategy 54 -- 4.2.2. Selection procedure 54 -- 4.2.3. Selection criteria 54 -- 4.3. RESULTS 54 -- 4.3.1. Overview of the search and selection process 54 -- 4.3.2. Study design 57 -- 4.3.3. Type of economic evaluation 57 -- 4.3.4. Time frame of analysis 57 -- 4.3.5. Discounting 57 -- 4.3.6. Perspective 58 -- 4.3.7. Population size 58 -- 4.3.8. Indications and comparators 58 -- 4.3.9. Overview of costs and outcomes 64 -- 4.3.10. Sensitivity analysis 66 -- 4.3.11. Battery life 66 -- 4.4. DISCUSSION 67 -- 4.4.1. Spinal cord stimulation 67 -- 4.4.2. Intrathecal analgesic delivery pumps 69 -- 4.5. KEY POINTS 69 -- 5. BELGIAN REGULATION FOR REIMBURSEMENT 70 -- 5.1. OVERALL LEGAL FRAMEWORK FOR REIMBURSEMENT OF MEDICAL ACTS 70 -- 5.2. LEGAL FRAMEWORK FOR IMPLANTABLE DEVICES 70 -- 5.3. REIMBURSEMENT MODALITIES FOR IMPLANTABLE DEVICES 70 -- 5.4. IMPLANTS CONCERNED BY THIS HTA 70 -- 5.4.1. Lists of implants accepted for reimbursement (‘limitative lists’) 70 -- 5.4.2. Warranty periods 71 -- 5.5. APPROVED INDICATIONS, DEVICES AND REGULATIONS 71 -- 5.6. PRESCRIBERS AND IMPLANTERS 71 -- 5.7. IMPLANT SUPPLIERS AND THE DELIVERY MARGIN 71 -- 5.8. APPROVED IMPLANTING CENTRES 72 -- 5.9. TRIAL PERIOD 72 -- 5.10. DRUGS APPROVED FOR INTRATHECAL ADMINISTRATION 72 -- 5.11. REQUEST FOR REIMBURSEMENT 72 -- 5.12. MEDICAL ACTS RELEVANT TO THIS HTA 73 -- 5.13. MULTIDISCIPLINARY TEAMS FOR PAIN MANAGEMENT 73 -- 5.14. ORGANISATION OF PAIN CENTRES 74 -- 5.15. SCIENTIFIC PAIN SOCIETIES 74 -- 5.16. KEY POINTS 75 -- 6. REGULATIONS FOR REIMBURSEMENT IN NEIGHBOURING COUNTRIES 75 -- 6.1. INTRODUCTION 75 -- 6.2. FRANCE 75 -- 6.2.1. Overall legal framework for reimbursement 75 -- 6.2.2. Legal framework and reimbursement modalities for implantable devices 76 -- 6.2.3. SCS reimbursement criteria 76 -- 6.2.4. IADP reimbursement criteria 77 -- 6.2.5. Number of procedures performed 78 -- 6.3. THE NETHERLANDS 78 -- 6.3.1. Overall legal framework for reimbursement 78 -- 6.3.2. Legal framework and reimbursement modalities for implantable devices 79 -- 6.3.3. SCS reimbursement criteria 79 -- 6.3.4. IADP reimbursement criteria 80 -- 6.3.5. Number of procedures performed 80 -- 6.4. GERMANY 80 -- 6.4.1. Overall legal framework for reimbursement 80 -- 6.4.2. Legal framework and reimbursement modalities for implantable devices 81 -- 6.4.3. SCS reimbursement criteria 82 -- 6.4.4. IADP reimbursement criteria 83 -- 6.4.5. Number of procedures performed 83 -- 6.5. UK 83 -- 6.5.1. Overall legal framework for reimbursement 83 -- 6.5.2. Legal framework and reimbursement modalities for implantable devices 83 -- 6.5.3. SCS reimbursement criteria 84 -- 6.5.4. IADP reimbursement criteria 85 -- 6.5.5. Number of procedures performed 85 -- 6.6. DISCUSSION 86 -- 6.6.1. Overview of the situation in different countries 86 -- 6.6.2. Approved indications 90 -- 6.6.3. Prescription and use modalities 90 -- 6.6.4. Number of procedures 91 -- 6.6.5. Conclusion. 91 -- 6.7. KEY POINTS 91 -- 7. NEUROMODULATION USE IN BELGIUM 92 -- 7.1. METHODOLOGY 92 -- 7.1.1. Description of the Belgian administrative databases used 92 -- 7.1.2. Data extraction 92 -- 7.1.3. Analysis 93 -- 7.2. IMPLANTED SYSTEMS: NUMBER, COST AND GEOGRAPHY 94 -- 7.2.1. Under- and over-reporting in the data 94 -- 7.2.2. Volumes and device expenses 94 -- 7.2.3. Geography of implants 95 -- 7.2.4. Geography of patients 96 -- 7.2.5. Total hospitalization cost per implant 97 -- 7.2.6. Yearly cost of neuromodulation implants in Belgium 98 -- 7.3. PATIENT CHARACTERISTICS 98 -- 7.3.1. Age and gender 98 -- 7.3.2. Chronology of implants 100 -- 7.3.3. Hospital diagnoses 100 -- 7.4. INDICATIONS IN PRACTICE 101 -- 7.4.1. Expert opinion 101 -- 7.4.2. Data analysis 101 -- 7.4.3. Back surgery in Belgium 102 -- 7.5. DEVICE SURVIVAL 103 -- 7.5.1. Data and methods 103 -- 7.5.2. Analysis 1: Base case scenario 2002-2008 104 -- 7.5.3. Analysis 2: Scenario with censoring only at date of last discharge 2002-2008 104 -- 7.5.4. Analysis 3: Scenario with censoring only at end of follow-up period if no dead was -- recorded previously 2002-2008 105 -- 7.5.5. Analysis 4: Scenario as in analysis 3 but without censoring at date of implantation of another type of device 2002-2008 106 -- 7.5.6. Analyses 5 to 8 (2006-2008) 107 -- 7.6. DISCUSSION 108 -- 7.7. KEY POINTS 109 -- APPENDICES 110 -- 1. APPENDIX TO CHAPTER ON CHRONIC PAIN 110 -- 1.1. OVERVIEW OF IASP PAIN DEFINITIONS 110 -- 2. APPENDIX TO CHAPTER ON NEUROMODULATION TECHNOLOGY 112 -- 2.1. OVERVIEW OF CONDITIONS AND THERAPIES COMMONLY ASSOCIATED WITH NEUROMODULATION 112 -- 3. APPENDIX TO CHAPTER ON EFFECTIVENESS AND SAFETY 113 -- 3.1. INTRODUCTION 113 -- 3.2. SEARCH STRATEGIES SYSTEMATIC LITERATURE REVIEW 113 -- 3.2.1. Pubmed through Medline 113 -- 3.2.2. EMBASE through OVID® 114 -- 3.2.3. Other searches 117 -- 3.2.4. Cochrane Central Register of Controlled Trials (CENTRAL) 117 -- 3.3. EVIDENCE FROM INTERVENTIONAL STUDIES 119 -- 3.3.1. Overview of systematic reviews and selected RCTs 119 -- 3.3.2. Assessment of methodological quality 126 -- 3.3.3. Evidence and GRADE tables 127 -- 3.4. ADDITIONAL SEARCHES FOR NON-INTERVENTIONAL EVIDENCE 155 -- 3.4.1. Additional searches in Pubmed using Medline 155 -- 3.4.2. Hand searching of four selected journals 155 -- 3.4.3. Update search through Cochrane Library 155 -- 3.4.4. Removal of duplicates 155 -- 4. APPENDIX TO CHAPTER ON ECONOMIC EVALUATION 156 -- 4.1. SEARCH STRATEGIES 156 -- 4.2. 159 -- 4.3. LITERATURE SELECTION PROCESS 160 -- 4.3.1. Spinal cord stimulation for FBSS 161 -- 4.3.2. Spinal cord stimulation for CRPS 163 -- 4.3.3. Spinal cord stimulation for critical limb ischemia 164 -- 4.3.4. Spinal cord stimulation for angina pectoris 165 -- 4.3.5. Intrathecal analgesic delivery pumps for FBSS 166 -- 4.4. DATA EXTRACTION TABLES – SCS 167 -- 4.5. DATA EXTRACTION TABLES – IADP 197 -- 5. APPENDIX TO CHAPTER ON BELGIAN REGULATION FOR REIMBURSEMENT. 202 -- 5.1. OVERALL LEGAL FRAMEWORK FOR REIMBURSEMENT OF MEDICAL ACTS 202 -- 5.2. LEGAL FRAMEWORK FOR IMPLANTABLE DEVICES 202 -- 5.2.1. Definition of an implant 202 -- 5.2.2. Belgian categories of implantable devices 202 -- 5.2.3. European classification of medical devices 203 -- 5.3. IMPLANTS CONCERNED BY THIS HTA 203 -- 5.3.1. Implants by category 203 -- 5.3.2. Description and structure of the limitative lists 205 -- 5.3.3. Warranty periods 207 -- 5.4. APPROVED INDICATIONS, DEVICES AND REGULATIONS 207 -- 5.4.1. Neurogenic pain syndromes 207 -- 5.4.2. Thromboangiitis obliterans 207 -- 5.4.3. Chronic pancreatitis 208 -- 5.4.4. Critical lower limb ischemia 208 -- 5.4.5. Rechargeable neurostimulator 208 -- 5.5. IMPLANT SUPPLIERS AND THE DELIVERY MARGIN 208 -- 5.5.1. National agreement 208 -- 5.5.2. The delivery margin 209 -- 5.6. APPROVED IMPLANTING CENTRES 209 -- 5.7. TRIAL PERIOD 209 -- 5.8. REQUEST FOR REIMBURSEMENT 209 -- 5.8.1. Requirement of a multidisciplinary team 209 -- 5.8.2. Contents of medical report 210 -- 5.9. MEDICAL ACTS RELEVANT TO THIS HTA 211 -- 5.10. MULTIDISCIPLINARY TEAMS FOR PAIN MANAGEMENT 213 -- 5.11. BELGIAN REFERRAL CENTRES FOR CHRONIC PAIN 213 -- 6. APPENDIX TO CHAPTER ON REGULATIONS FOR REIMBURSEMENT IN NEIGHBOURING COUNTRIES 214 -- 6.1. FRANCE 214 -- 6.2. THE NETHERLANDS 215 -- 6.3. GERMANY 216 -- 6.4. UK 217 -- 7. APPENDIX TO CHAPTER ON NEUROMODULATION USE IN BELGIUM 218 -- 7.1. METHODOLOGY 218 -- 7.2. DESCRIPTIVE ANALYSES 218 -- 7.2.1. Baseline data 218 -- 7.2.2. Under- and over-reporting in the data 221 -- 7.2.3. Patient characteristics 222 -- 7.2.4. Hospitalization Diagnoses 223 -- 7.2.5. Implants Geography 231 -- 7.2.6. Number of implants per hospital 233 -- 7.2.7. Patient chronology 233 -- 7.3. DEVICE SURVIVAL 234 -- 7.4. HOSPITALIZATION COSTS PER IMPLANT 237 -- 7.4.1. Data cleaning 237 -- 7.4.2. Reconstruction of the part of the hospital financing related to an hospitalization stay in particular 237 -- 7.4.3. Scenarios 237 -- 7.4.4. Results 237 -- REFERENCES 242 Link for e-copy: http://doi.org/10.57598/R189C Format of e-copy: PDF (2 MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=3093 Copies(0)
Status No copy Neuromodulation pour la prise en charge de la douleur chronique / Cécile Camberlin / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2012)
Neuromodulation pour la prise en charge de la douleur chronique : systèmes implantés de neurostimulation médullaire et pompes intrathécales analgésiques [printed text] / Cécile Camberlin , Author ; Lorena San Miguel , Author ; Yolba Smit, Author ; Piet Post, Author ; Sophie Gerkens , Author ; Chris De Laet , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2012 . - VII, 253 p. : Ill. ; A4. - (KCE Reports B. Health Technology Assessment (HTA); 189B) .
ISSN : D/2012/10.273/75 : € 0,00
Etude 2010-13 HTA Spinal Cord Stimulation
Languages : English (eng) French (fre)
Descriptors: Indexation
2010-13 ; Chronic Pain ; Electric Stimulation Therapy ; Infusion Pumps, Implantable ; Pain ; Pain, Intractable ; prevention and control ; R189
Classification
WL 704.6 Pain managementAbstract: Le Centre Fédéral d’Expertise des Soins de santé (KCE) s’est penché sur la stimulation de la moelle épinière et les pompes à douleur (IADP), deux techniques de neuromodulation visant à lutter contre les douleurs chroniques sévères. Les preuves scientifiques de leur efficacité sont limitées et ces techniques, comme d’ailleurs toutes les interventions invasives, ne sont pas sans risques. C’est pourquoi il ne faut les utiliser que dans les cas où les autres thérapies ont toutes échoué. Comparé aux pays voisins, le nombre d’interventions de neuromodulation est particulièrement élevé en Belgique. Ce qui pourrait s’expliquer par le nombre important d’opérations du dos dans notre pays. Contents note: SYNTHÈSE 18 -- 1. OBJECTIF ET PORTÉE 18 -- 2. LES DOULEURS CHRONIQUES ET LEUR PRISE EN CHARGE 19 -- 2.1. COMMENT DÉFINIR ET MESURER LA DOULEUR? 19 -- 2.2. DOULEUR NOCICEPTIVE VERSUS DOULEUR NEUROPATHIQUE 19 -- 2.3. DOULEUR CHRONIQUE 19 -- 2.4. PRISE EN CHARGE DES DOULEURS CHRONIQUES 20 -- 3. TECHNIQUES DE NEUROMODULATION 20 -- 4. LES INDICATIONS LES PLUS FRÉQUENTES 21 -- 5. EFFICACITÉ ET SECURITÉ 22 -- 5.1. PREUVE D’EFFICACITÉ LIMITÉE 22 -- 5.2. SÉCURITÉ 23 -- 5.3. CONCLUSION 23 -- 6. EVALUATION ECONOMIQUE 23 -- 7. REGLEMENTATIONS ET REMBOURSEMENT 24 -- 7.1. INDICATIONS 24 -- 7.2. DURÉE DE LA PÉRIODE D’ESSAI 25 -- 7.3. CHOIX DE L’IMPLANT 25 -- 8. UTILISATION ACTUELLE ET COÛTS 25 -- 8.1. DONNÉES 25 -- 8.2. SYSTÈMES IMPLANTÉS 25 -- 8.3. PATIENTS ET INDICATIONS 26 -- 8.4. DURÉE DE VIE DES PILES 26 -- 9. CONCLUSION 27 -- SCIENTIFIC REPORT 28 -- SCOPE OF THIS REPORT 28 -- 1. CHRONIC PAIN AND ITS MANAGEMENT 29 -- 1.1. INTRODUCTION 29 -- 1.2. GENERAL DEFINITION OF PAIN 29 -- 1.3. SPECIFIC DEFINITIONS OF PAIN 30 -- 1.3.1. Nociceptive pain 30 -- 1.3.2. Neuropathic pain 30 -- 1.3.3. Paraesthesia 30 -- 1.3.4. Pain threshold and pain tolerance 30 -- 1.4. DURATION OF PAIN 31 -- 1.5. EPIDEMIOLOGY OF PAIN 31 -- 1.6. DIAGNOSIS AND MEASUREMENT OF PAIN 31 -- 1.7. MANAGEMENT OF CHRONIC PAIN 32 -- 1.8. PAIN MANAGEMENT FACILITIES 32 -- 1.8.1. Multidisciplinary pain centres 32 -- 1.8.2. Other forms of pain centres 33 -- 1.9. THE MOST COMMON INDICATIONS FOR NEUROMODULATION 33 -- 1.9.1. Failed back surgery syndrome (FBSS) 33 -- 1.9.2. Complex regional pain syndrome (CRPS) 33 -- 1.9.3. Critical limb ischemia (CLI) 33 -- 1.9.4. Refractory angina pectoris (AP) 33 -- 1.9.5. Refractory cancer pain 34 -- 2. NEUROMODULATION TECHNIQUES 34 -- 2.1. DEFINITION OF NEUROMODULATION AND SCOPE OF THIS REPORT 34 -- 2.1. SCS TECHNOLOGY 35 -- 2.1.1. Definition of SCS 35 -- 2.1.2. History of SCS 35 -- 2.1.3. Mechanism of SCS action 36 -- 2.1.4. Claimed advantages of SCS 37 -- 2.1.5. Disadvantages of SCS 37 -- 2.1.6. The SCS system 37 -- 2.1.7. SCS procedures 38 -- 2.2. IADP TECHNOLOGY 39 -- 2.2.1. Definition of IADP 39 -- 2.2.2. History of IADP 39 -- 2.2.3. Mechanism of IADP action 39 -- 2.2.4. Claimed advantages of IADP 40 -- 2.2.5. Disadvantages of IADP 40 -- 2.2.6. The IADP system 40 -- 2.2.7. IADP procedures 41 -- 3. EFFECTIVENESS AND SAFETY 41 -- 3.1. INTRODUCTION 41 -- 3.2. METHODS 41 -- 3.2.1. Types of studies 41 -- 3.2.2. Patients included 41 -- 3.2.3. Types of interventions 41 -- 3.2.4. Types of outcome measures 42 -- 3.2.5. Search strategy for the systematic literature review 42 -- 3.2.6. Reference tracking 42 -- 3.2.7. Data collection and analysis 42 -- 3.3. RESULTS 43 -- 3.3.1. Overview of the search and selection process 43 -- 3.3.2. Spinal cord stimulation in patients with failed back surgery syndrome (FBSS) 44 -- 3.3.3. Spinal cord stimulation in patients with complex regional pain syndrome (CRPS) 45 -- 3.3.4. Spinal cord stimulation in patients with diabetic neuropathy 46 -- 3.3.5. Spinal cord stimulation in patients with critical limb ischemia (CLI) 46 -- 3.3.6. Spinal cord stimulation in patients with refractory angina pectoris (RAP) 48 -- 3.3.7. Intrathecal Analgesic Delivery Pumps 50 -- 3.4. ONGOING CLINICAL TRIALS 51 -- 3.5. DISCUSSION 52 -- 3.5.1. Evidence from interventional research 52 -- 3.5.2. Safety issues 53 -- 3.5.3. Evidence from observational research 53 -- 3.5.4. Conclusion. 53 -- 3.6. KEY POINTS 54 -- 4. ECONOMIC EVALUATION 55 -- 4.1. INTRODUCTION 55 -- 4.2. METHODS 55 -- 4.2.1. Search strategy 55 -- 4.2.2. Selection procedure 55 -- 4.2.3. Selection criteria 55 -- 4.3. RESULTS 55 -- 4.3.1. Overview of the search and selection process 55 -- 4.3.2. Study design 58 -- 4.3.3. Type of economic evaluation 58 -- 4.3.4. Time frame of analysis 58 -- 4.3.5. Discounting 58 -- 4.3.6. Perspective 59 -- 4.3.7. Population size 59 -- 4.3.8. Indications and comparators 59 -- 4.3.9. Overview of costs and outcomes 65 -- 4.3.10. Sensitivity analysis 67 -- 4.3.11. Battery life 67 -- 4.4. DISCUSSION 68 -- 4.4.1. Spinal cord stimulation 68 -- 4.4.2. Intrathecal analgesic delivery pumps 70 -- 4.5. KEY POINTS 70 -- 5. BELGIAN REGULATION FOR REIMBURSEMENT 71 -- 5.1. OVERALL LEGAL FRAMEWORK FOR REIMBURSEMENT OF MEDICAL ACTS 71 -- 5.2. LEGAL FRAMEWORK FOR IMPLANTABLE DEVICES 71 -- 5.3. REIMBURSEMENT MODALITIES FOR IMPLANTABLE DEVICES 71 -- 5.4. IMPLANTS CONCERNED BY THIS HTA 71 -- 5.4.1. Lists of implants accepted for reimbursement (‘limitative lists’) 71 -- 5.4.2. Warranty periods 72 -- 5.5. APPROVED INDICATIONS, DEVICES AND REGULATIONS 72 -- 5.6. PRESCRIBERS AND IMPLANTERS 72 -- 5.7. IMPLANT SUPPLIERS AND THE DELIVERY MARGIN 72 -- 5.8. APPROVED IMPLANTING CENTRES 73 -- 5.9. TRIAL PERIOD 73 -- 5.10. DRUGS APPROVED FOR INTRATHECAL ADMINISTRATION 73 -- 5.11. REQUEST FOR REIMBURSEMENT 73 -- 5.12. MEDICAL ACTS RELEVANT TO THIS HTA 74 -- 5.13. MULTIDISCIPLINARY TEAMS FOR PAIN MANAGEMENT 74 -- 5.14. ORGANISATION OF PAIN CENTRES 75 -- 5.15. SCIENTIFIC PAIN SOCIETIES 75 -- 5.16. KEY POINTS 76 -- 6. REGULATIONS FOR REIMBURSEMENT IN NEIGHBOURING COUNTRIES 76 -- 6.1. INTRODUCTION 76 -- 6.2. FRANCE 76 -- 6.2.1. Overall legal framework for reimbursement 76 -- 6.2.2. Legal framework and reimbursement modalities for implantable devices 77 -- 6.2.3. SCS reimbursement criteria 77 -- 6.2.4. IADP reimbursement criteria 78 -- 6.2.5. Number of procedures performed 79 -- 6.3. THE NETHERLANDS 79 -- 6.3.1. Overall legal framework for reimbursement 79 -- 6.3.2. Legal framework and reimbursement modalities for implantable devices 80 -- 6.3.3. SCS reimbursement criteria 80 -- 6.3.4. IADP reimbursement criteria 81 -- 6.3.5. Number of procedures performed 81 -- 6.4. GERMANY 81 -- 6.4.1. Overall legal framework for reimbursement 81 -- 6.4.2. Legal framework and reimbursement modalities for implantable devices 82 -- 6.4.3. SCS reimbursement criteria 83 -- 6.4.4. IADP reimbursement criteria 84 -- 6.4.5. Number of procedures performed 84 -- 6.5. UK 84 -- 6.5.1. Overall legal framework for reimbursement 84 -- 6.5.2. Legal framework and reimbursement modalities for implantable devices 84 -- 6.5.3. SCS reimbursement criteria 85 -- 6.5.4. IADP reimbursement criteria 86 -- 6.5.5. Number of procedures performed 86 -- 6.6. DISCUSSION 87 -- 6.6.1. Overview of the situation in different countries 87 -- 6.6.2. Approved indications 91 -- 6.6.3. Prescription and use modalities 91 -- 6.6.4. Number of procedures 92 -- 6.6.5. Conclusion. 92 -- 6.7. KEY POINTS 92 -- 7. NEUROMODULATION USE IN BELGIUM 93 -- 7.1. METHODOLOGY 93 -- 7.1.1. Description of the Belgian administrative databases used 93 -- 7.1.2. Data extraction 93 -- 7.1.3. Analysis 94 -- 7.2. IMPLANTED SYSTEMS: NUMBER, COST AND GEOGRAPHY 95 -- 7.2.1. Under- and over-reporting in the data 95 -- 7.2.2. Volumes and device expenses 95 -- 7.2.3. Geography of implants 96 -- 7.2.4. Geography of patients 97 -- 7.2.5. Total hospitalization cost per implant 98 -- 7.2.6. Yearly cost of neuromodulation implants in Belgium 99 -- 7.3. PATIENT CHARACTERISTICS 99 -- 7.3.1. Age and gender 99 -- 7.3.2. Chronology of implants 101 -- 7.3.3. Hospital diagnoses 101 -- 7.4. INDICATIONS IN PRACTICE 102 -- 7.4.1. Expert opinion 102 -- 7.4.2. Data analysis 102 -- 7.4.3. Back surgery in Belgium 103 -- 7.5. DEVICE SURVIVAL 104 -- 7.5.1. Data and methods 104 -- 7.5.2. Analysis 1: Base case scenario 2002-2008 105 -- 7.5.3. Analysis 2: Scenario with censoring only at date of last discharge 2002-2008 105 -- 7.5.4. Analysis 3: Scenario with censoring only at end of follow-up period if no dead was recorded previously 2002-2008 106 -- 7.5.5. Analysis 4: Scenario as in analysis 3 but without censoring at date of implantation of another type of device 2002-2008 107 -- 7.5.6. Analyses 5 to 8 (2006-2008) 108 -- 7.6. DISCUSSION 109 -- 7.7. KEY POINTS 110 -- APPENDICES 111 -- 1. APPENDIX TO CHAPTER ON CHRONIC PAIN 111 -- 1.1. OVERVIEW OF IASP PAIN DEFINITIONS 111 -- 2. APPENDIX TO CHAPTER ON NEUROMODULATION TECHNOLOGY 113 -- 2.1. OVERVIEW OF CONDITIONS AND THERAPIES COMMONLY ASSOCIATED WITH NEUROMODULATION 113 -- 3. APPENDIX TO CHAPTER ON EFFECTIVENESS AND SAFETY 114 -- 3.1. INTRODUCTION 114 -- 3.2. SEARCH STRATEGIES SYSTEMATIC LITERATURE REVIEW 114 -- 3.2.1. Pubmed through Medline 114 -- 3.2.2. EMBASE through OVID® 115 -- 3.2.3. Other searches 118 -- 3.2.4. Cochrane Central Register of Controlled Trials (CENTRAL) 118 -- 3.3. EVIDENCE FROM INTERVENTIONAL STUDIES 120 -- 3.3.1. Overview of systematic reviews and selected RCTs 120 -- 3.3.2. Assessment of methodological quality 127 -- 3.3.3. Evidence and GRADE tables 128 -- 3.4. ADDITIONAL SEARCHES FOR NON-INTERVENTIONAL EVIDENCE 156 -- 3.4.1. Additional searches in Pubmed using Medline 156 -- 3.4.2. Hand searching of four selected journals 156 -- 3.4.3. Update search through Cochrane Library 156 -- 3.4.4. Removal of duplicates 156 -- 4. APPENDIX TO CHAPTER ON ECONOMIC EVALUATION 157 -- 4.1. SEARCH STRATEGIES 157 -- 4.2. 160 -- 4.3. LITERATURE SELECTION PROCESS 161 -- 4.3.1. Spinal cord stimulation for FBSS 162 -- 4.3.2. Spinal cord stimulation for CRPS 164 -- 4.3.3. Spinal cord stimulation for critical limb ischemia 165 -- 4.3.4. Spinal cord stimulation for angina pectoris 166 -- 4.3.5. Intrathecal analgesic delivery pumps for FBSS 167 -- 4.4. DATA EXTRACTION TABLES – SCS 168 -- 4.5. DATA EXTRACTION TABLES – IADP 198 -- 5. APPENDIX TO CHAPTER ON BELGIAN REGULATION FOR REIMBURSEMENT. 203 -- 5.1. OVERALL LEGAL FRAMEWORK FOR REIMBURSEMENT OF MEDICAL ACTS 203 -- 5.2. LEGAL FRAMEWORK FOR IMPLANTABLE DEVICES 203 -- 5.2.1. Definition of an implant 203 -- 5.2.2. Belgian categories of implantable devices 203 -- 5.2.3. European classification of medical devices 204 -- 5.3. IMPLANTS CONCERNED BY THIS HTA 204 -- 5.3.1. Implants by category 204 -- 5.3.2. Description and structure of the limitative lists 206 -- 5.3.3. Warranty periods 208 -- 5.4. APPROVED INDICATIONS, DEVICES AND REGULATIONS 208 -- 5.4.1. Neurogenic pain syndromes 208 -- 5.4.2. Thromboangiitis obliterans 208 -- 5.4.3. Chronic pancreatitis 209 -- 5.4.4. Critical lower limb ischemia 209 -- 5.4.5. Rechargeable neurostimulator 209 -- 5.5. IMPLANT SUPPLIERS AND THE DELIVERY MARGIN 209 -- 5.5.1. National agreement 209 -- 5.5.2. The delivery margin 210 -- 5.6. APPROVED IMPLANTING CENTRES 210 -- 5.7. TRIAL PERIOD 210 -- 5.8. REQUEST FOR REIMBURSEMENT 210 -- 5.8.1. Requirement of a multidisciplinary team 210 -- 5.8.2. Contents of medical report 211 -- 5.9. MEDICAL ACTS RELEVANT TO THIS HTA 212 -- 5.10. MULTIDISCIPLINARY TEAMS FOR PAIN MANAGEMENT 214 -- 5.11. BELGIAN REFERRAL CENTRES FOR CHRONIC PAIN 214 -- 6. APPENDIX TO CHAPTER ON REGULATIONS FOR REIMBURSEMENT IN NEIGHBOURING COUNTRIES 215 -- 6.1. FRANCE 215 -- 6.2. THE NETHERLANDS 216 -- 6.3. GERMANY 217 -- 6.4. UK 218 -- 7. APPENDIX TO CHAPTER ON NEUROMODULATION USE IN BELGIUM 219 -- 7.1. METHODOLOGY 219 -- 7.2. DESCRIPTIVE ANALYSES 219 -- 7.2.1. Baseline data 219 -- 7.2.2. Under- and over-reporting in the data 222 -- 7.2.3. Patient characteristics 223 -- 7.2.4. Hospitalization Diagnoses 224 -- 7.2.5. Implants Geography 232 -- 7.2.6. Number of implants per hospital 234 -- 7.2.7. Patient chronology 234 -- 7.3. DEVICE SURVIVAL 235 -- 7.4. HOSPITALIZATION COSTS PER IMPLANT 238 -- 7.4.1. Data cleaning 238 -- 7.4.2. Reconstruction of the part of the hospital financing related to an hospitalization stay in particular 238 -- 7.4.3. Scenarios 238 -- 7.4.4. Results 238 -- REFERENCES 243 Link for e-copy: http://doi.org/10.57598/R189B Format of e-copy: PDF (2,02MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=3094 Copies(0)
Status No copy Neuromodulation pour la prise en charge de la douleur chronique / Cécile Camberlin / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2012)
Neuromodulation pour la prise en charge de la douleur chronique : systèmes implantés de neurostimulation médullaire et pompes intrathécales analgésiques - Synthèse [printed text] / Cécile Camberlin , Author ; Lorena San Miguel , Author ; Yolba Smit, Author ; Piet Post, Author ; Sophie Gerkens , Author ; Chris De Laet , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2012 . - 14 p. : Ill. ; A4. - (KCE Reports B. Health Technology Assessment (HTA); 189Bs) .
ISSN : D/2012/10.273/78 : € 0,00
Etude 2010-13 HTA Spinal Cord Stimulation
Languages : French (fre)
Descriptors: Indexation
2010-13 ; Chronic Pain ; Electric Stimulation Therapy ; Infusion Pumps, Implantable ; Pain ; Pain, Intractable ; prevention and control ; R189
Classification
WL 704.6 Pain managementAbstract: Le Centre Fédéral d’Expertise des Soins de santé (KCE) s’est penché sur la stimulation de la moelle épinière et les pompes à douleur (IADP), deux techniques de neuromodulation visant à lutter contre les douleurs chroniques sévères. Les preuves scientifiques de leur efficacité sont limitées et ces techniques, comme d’ailleurs toutes les interventions invasives, ne sont pas sans risques. C’est pourquoi il ne faut les utiliser que dans les cas où les autres thérapies ont toutes échoué. Comparé aux pays voisins, le nombre d’interventions de neuromodulation est particulièrement élevé en Belgique. Ce qui pourrait s’expliquer par le nombre important d’opérations du dos dans notre pays. Link for e-copy: http://doi.org/10.57598/R189BS Format of e-copy: PDF (244 Kb) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=3095 Copies(0)
Status No copy