Overview
Although ziconotide's marketing authorization does not restrict its use to a given type of pain, the drug has been used mainly in cancer patients. Most data on ziconotide-based intrathecal (IT) treatment has therefore been obtained in this population, for whom the drug's place is clearly documented (national and international recommendations).
In contrast the management of non-cancer pain is less straightforward, partly because of the very large range of possible clinical conditions, and the utilization of ziconotide is poorly documented, mainly described in single-centre small series.
Due to the lack of data, physicians are often reluctant to undertake this type of treatment, which may represent a loss of opportunity for patients.
This registry aims at providing information on patients suffering from non-cancer pain refractory to standard therapy, treated by ziconotide-based intrathecal analgesia.
Patients suffering from all types of non-malignant pain will be eligible for the study, including but not limited to spinal cord injury, radiculopathy, failed back surgery, diabetic neuropathy, central pain syndrome, complex regional pain syndrome, chemotherapy-induced neuropathy, fibromyalgia.
The collected data will cover the first 2 years of treatment.
Eligibility
Inclusion Criteria:
- Age ≥18 years,
- Chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy,
- Having received information on and not opposed to data collection,
Inclusion criteria specific for the retrospective cohort:
Currently treated by ziconotide-based ITA according to SmPC whatever the duration of treatment
Inclusion criteria specific for the prospective cohort:
Naïve of ITA and candidate to ziconotide-based ITA or already treated by IT route without ziconotide, scheduled for addition of ziconotide in the pump
Exclusion Criteria:
- Contraindication to intrathecal therapy or to ziconotide
- Any condition that may jeopardize appropriate follow-up of the treatment
- Patient under guardianship or deprived of liberty by a judicial or administrative decision or unable to express opposition to data collection.