With this study, which is estimated to be completed within 1 year, we aim to determine whether medicinal cannabis oil will influence the pain experience of EB-patients. The study focuses solely on the symptomatic experience of patients, with specific regard to pain. The disease pathogenesis will not be investigated.
This research is a cross-over study. The participants are given both the cannabis oil and the placebo. There are a limited number of patients with EB who are able to participate, and who meet the strict criteria for participation. Sixteen patients will be selected to participate. In the study, an additional parameter for pain outcomes include the use of functional magnetic resonance imaging (fMRI). fMRI creates a 3D image of the brain. The neuroanatomical areas and the brain activity, that are responsible for processing pain, become visible. This gives a picture of what the pain circuit looks like in EB patients before and after treatment with cannabis oil. Furthermore the patients’ self-reported pain scores on a scale of 0-10 for a complete picture of the pain experience of the patient.
In the Netherlands there are approximately 500 patients with EB, 90 percent of whom are being treated in the UMCG at the Center for Blister Diseases. What doctors have at their disposal to relieve pain for EB patients is not enough. The pain starts at birth and lasts a lifetime as the blisters and wounds keep coming. There is no cure. Many pain interventions are not intended to be used for years, but unfortunately this is necessary for EB patients. It is not only about wound and care pain, but also pain that can occur in different places in the body without being anatomically explained. Pain management is crucial for EB patients. Pain often has a negative influence on the mental state, behavior and interaction of people with those around them. People are often anxious, depressed or incapacitated for work and become socially isolated.
In the Netherlands there are approximately 500 patients with EB, 90 percent of whom are being treated in the UMCG at the Center for Blister Diseases. What doctors have at their disposal to relieve pain for EB patients is not enough. The pain starts at birth and lasts a lifetime as the blisters and wounds keep coming. There is no cure. Many pain interventions are not intended to be used for years, but unfortunately this is necessary for EB patients. It is not only about wound and care pain, but also pain that can occur in different places in the body without being anatomically explained. Pain management is crucial for EB patients. Pain often has a negative influence on the mental state, behavior and interaction of people with those around them. People are often anxious, depressed or incapacitated for work and become socially isolated.
