Extrait

Background and study aims Neuropathic pain (also known as nerve pain) can arise from direct damage to the nervous system. Neuropathic pain is unbearable and existing treatments are often ineffective or cause significant side effects, which limits their use. In healthy people we can study the symptoms of neuropathic pain by applying capsaicin cream to the surface of the skin. Capsaicin is the ingredient that makes chilli peppers hot. Application of the cream to the skin usually causes a mild to moderate burning sensation in most people. There is also an increase in sensitivity to temperature and touch that can be measured using sensory tests. Researchers can therefore test the effects of new pain treatments. The effects of capsaicin are temporary and disappear when the cream is wiped off. However, conducting research in healthy people using capsaicin cream is extremely useful. It helps us predict the effectiveness of new pain treatments on the symptoms of neuropathic pain in patients. Researchers at the University of Cambridge have discovered that Ivabradine may reduce pain by suppressing the abnormal firing of ‘pain nerves’. Ivabradine is not a completely new drug in humans. It is already licensed as a treatment for patients with chest pain (from heart disease) and the safety of Ivabradine has been shown in healthy volunteers. In this study, we will be looking at whether Ivabradine might be useful as a new treatment for nerve pain. Who can participate? Healthy adults aged 18-64 who are not taking any pain medication. What does the study involve? Participants will attend hospital for a maximum of three visits (each visit will last 3-4 hours). Visit 1 will be a ‘screening’ visit to find out if the volunteer is suitable to participate in the study. The study procedures will first be explained, and if the volunteer agrees to take part, they will be asked to sign an Informed Consent form. The volunteer’s response to a variety of stimuli applied to their forearm will then be assessed – these stimuli include a light touch with a soft brush, pokes with a brush filament and temperature tests – this is called ‘Quantitative Sensory Testing’ (QST). The volunteer’s response to capsaicin cream will then be tested by applying the cream to the skin of the forearm and repeating the QST. Not everyone will be suitable for the study, as some may not be sufficiently sensitive to the capsaicin cream, whereas others may find the cream too uncomfortable. Hence this screening visit – only those volunteers showing a suitable response to capsaicin will progress to the second and third visits. For those eligible to participate in the study, Visit 2 will take place about three weeks after Visit 1. Many of the tests performed in Visit 1 will be repeated in Visit 2, including the initial QST. However, before the application of the capsaicin cream, the volunteer will be asked to swallow tablets with water – these tablets will either be Ivabradine or a placebo (a dummy tablet), but neither the volunteer nor the study team will know which the tablets are. Following the application of the capsaicin cream, the QST will be repeated. Visit 3 will take place about one week after Visit 2, and will follow the same procedure used for Visit 2. However, the capsaicin cream will be applied to the arm opposite that used for Visit 2. What are the possible benefits and risks of participating? This is a healthy volunteer study, and volunteers will not benefit from participating; however, information collected as part of your participation may benefit patients with neuropathic pain in the future. You will also receive an honorarium payment in compensation for your time and inconvenience. Risks associated with the capsaicin cream include: (a) it may cause a burning sensation upon application, (b) the skin where the capsaicin is applied may be sensitive for up to four hours (and may remain red for up to two hours) after the capsaicin is removed. However, these effects should completely disappear overnight or within 24 hours. As with other medications, some possible side effects may result from taking Ivabradine (please contact the study team for details); however, it is unlikely that these would be experienced by the volunteers on this study, who only take a single dose of this medication. Throughout the study visits, the volunteers will be closely monitored by the medical team to ensure there are no safety issues. Where is the study run from? Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK. When is the study starting and how long is it expected to run for? The study starts in July 2014 and is expected to run until December 2015. Who is funding the study? Medical Research Council (MRC), UK. Who is the main contact? Dr Michael Lee [email protected]

Critère d'inclusion

• Topic: Anaesthesia, perioperative medicine and pain management; Subtopic: Anaesthesia,
• perioperative medicine and pain management; Disease: All Anaesthesia, perioperative medicine and
• pain management

Liens

• ictrp
• isrctn