The study investigates the impact of SCS treatment on experimentally induced central sensitization phenomena by investigating the SCS effects on the development of capsaicin- induced secondary skin hyperalgesia in humans. To do so, we: 1. Test an acute human model of skin hyperalgesia induced by the application of a high-concentration capsaicin patch in a control cohort of healthy subjects, recording baseline measurements to be used as local reference values. 2. Apply the same model of skin hyperalgesia on a subset of chronic low back pain (CLBP) patients. We record measurements a) before and after undergoing an SCS implant, b) in patients scheduled to have different types of SCS systems. The presence and/or extension of capsaicin-induced secondary hyperalgesia is assessed as primary endpoint, and the study will try to refuse the following null hypothesis: 1. there is equivalence in the area of capsaicin-induced secondary hyperalgesia in both the healthy volunteers and chronic pain patients (in the absence of SCS) 2. there is equivalence in the area of capsaicin-induced secondary hyperalgesia before and after SCS treatment 3. there is equivalence in the area of capsaicin-induced secondary hyperalgesia in patients treated with 2 different SCS systems (50Hz and 10kHz).
Lo studio ha lo scopo di indagare l’impatto del trattamento con SCS sui fenomeni di sensibilizzazione centrale valutando l’influenza della SCS sullo sviluppo dell’area di iperalgesia secondaria indotta sperimentalmente attraverso l’applicazione cutanea di capsaicina in soggetti umani. A tale scopo si intende : 1.testare un modello umano di iperalgesia secondaria indotta attraverso l’ applicazione cutanea di un cerotto ad alta concentrazione di capsaicina in una coorte di volontari sani e registrarene le misurazioni come valori di riferimento. 2.applicare il medesimo modello sperimentale di iperalgesia in una coorte di pazienti affetti da dolore cronico lombare, registrane le misurazioni a) prima e dopo l’impianto dello stimolatore midollare e b) in pazienti in programma per differenti tipi di SCS. La valutazione della presenza e/o estensione dell’area di iperlagesia secondaria indotta dalla capsaicina rappresenta l’endpoint primario e lo studio cercherà di negare le seguenti ipotesi nulle: 1.C’è equivalenza nell’area di iperalgesia secondaria indotta dalla capsaicina tra volontari sani e pazienti affetti da dolore cronico (in assenza di SCS) 2.C’è equivalenza nell’area di iperalgesia secondaria indotta dalla capsaicina prima e dopo il trattamento con SCS 3.C’è equivalenza nell’area di iperalgesia secondaria indotta dalla capsaicina in pazienti trattatati con due differenti sistemi di SCS (50Hz e 10kHz)
Influenza della neurostimolazione midollare sui meccanismi intraspinali di modulazione del dolore
MAZZOLENI, SILVIA
2015/2016
Abstract
The study investigates the impact of SCS treatment on experimentally induced central sensitization phenomena by investigating the SCS effects on the development of capsaicin- induced secondary skin hyperalgesia in humans. To do so, we: 1. Test an acute human model of skin hyperalgesia induced by the application of a high-concentration capsaicin patch in a control cohort of healthy subjects, recording baseline measurements to be used as local reference values. 2. Apply the same model of skin hyperalgesia on a subset of chronic low back pain (CLBP) patients. We record measurements a) before and after undergoing an SCS implant, b) in patients scheduled to have different types of SCS systems. The presence and/or extension of capsaicin-induced secondary hyperalgesia is assessed as primary endpoint, and the study will try to refuse the following null hypothesis: 1. there is equivalence in the area of capsaicin-induced secondary hyperalgesia in both the healthy volunteers and chronic pain patients (in the absence of SCS) 2. there is equivalence in the area of capsaicin-induced secondary hyperalgesia before and after SCS treatment 3. there is equivalence in the area of capsaicin-induced secondary hyperalgesia in patients treated with 2 different SCS systems (50Hz and 10kHz).È consentito all'utente scaricare e condividere i documenti disponibili a testo pieno in UNITESI UNIPV nel rispetto della licenza Creative Commons del tipo CC BY NC ND.
Per maggiori informazioni e per verifiche sull'eventuale disponibilità del file scrivere a: unitesi@unipv.it.
https://hdl.handle.net/20.500.14239/19022