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.
Study Type
OBSERVATIONAL
Enrollment
85
Intrathecal injection of ziconotide, using an internal pump, surgically inserted by a trained neurosurgeon or anesthesiologist, under general anesthesia.
Clinique de la Casamance
Aubagne, France
RECRUITINGHospices Civils de Lyon
Bron, France
RECRUITINGPolyclinique du Parc
Caen, France
NOT_YET_RECRUITINGCHD Vendée
La Roche-sur-Yon, France
RECRUITINGCH Laon
Laon, France
RECRUITINGCHU Lille
Lille, France
RECRUITINGClinique Mutualiste de la Porte de l'Orient
Lorient, France
RECRUITINGCentre Léon Bérard
Lyon, France
RECRUITINGHopital Saint Joseph
Paris, France
NOT_YET_RECRUITINGCHU Poitiers
Poitiers, France
NOT_YET_RECRUITING...and 4 more locations
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: demographic characteristics
Patient's demographic characteristics
Time frame: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: medical history
Relevant medical history, including history of psychiatric disorders
Time frame: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: indication for intrathecal ziconotide
Indication for ziconotide initiation (mechanism of pain and etiology)
Time frame: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: starting date of pain
Starting date of severe/disabling pain
Time frame: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: history of pain management
History of pain management including prior interventional techniques and current analgesic treatment (administered when decision of ziconotide treatment is made)
Time frame: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: pain intensity
Numerical Rating Scale score for pain (graduated from 0: absence of pain to 10: worst possible pain) analgesic treatment (administered when decision of ziconotide treatment is made)
Time frame: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: neuro-psychiatric condition
NPI-ES score (NeuroPsychiatric Inventory of An inventory of 12 of the most frequent symptoms of Alzheimer's disease and related disorders, assessing their frequency and severity, as well as the impact on the caregiver or professional), or score of another type or neuropsychological evaluation questionnaire)
Time frame: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: disability condition
Owestry disability index score: patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in 10 activities of daily living
Time frame: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: anxiety and depression disorders
Hospital Anxiety and Depression Scale (HADS) score: patient-completed questionnaire with 14 items assessing anxiety and depressive disorders
Time frame: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: reasons for initiating ziconotide
Reasons for initiating ziconotide (process of medical decision)
Time frame: Baseline (treatment initiation)
Describe the characteristics of patients treated by intrathecal ziconotide for chronic non-cancer pain: planned modification of the current intrathecal treatment
Planned modification of the current intrathecal treatment
Time frame: Baseline (treatment initiation)
Describe the modalities of ziconotide therapy at ziconotide initiation
Ziconotide initial dose, concentration in the pump, administration in monotherapy or in combination, planned titration schedule, and concomitant non-IT analgesics.
Time frame: Baseline (treatment initiation)
Describe the modalities of ziconotide therapy during follow-up
Drugs added in or removed from the mixture ; Ziconotide posology and concentration in the pump, or ziconotide discontinuation; Evaluation of dose efficacy; Concomitant non-IT analgesics
Time frame: 2 years follow-up
Describe the patient's care pathway and treatment management
Characteristics of the physician who includes the patient; Decision to administer ziconotide in multidisciplinary meeting (MDM) and MDM members if applicable or specialty of the physician who made the decision if no MDM was organized; Type of investigations performed at inclusion and/or during follow-up (NPI-ES score or other type of neuropsychiatric evaluation), Owestry disability index, Hospital Anxiety and Depression Scale; Data on pump implantation
Time frame: 2 years follow-up
Describe the effect of treatment on pain evolution
Numerical Rating Scale (NRS) score graduated from 0 (absence of pain) to 10 (worst possible pain) collected at each visit, from inclusion to last visit
Time frame: 2 years follow-up
Describe the effect of treatment on disability
Owestry disability index
Time frame: 3 months, 1 year and 2 years.
Describe the effect of treatment on anxiety and depression
Hospital Anxiety and Depression Scale score
Time frame: 3 months, 1 year and 2 years.
Describe the safety and tolerability of treatment
Adverse events, related to the intrathecal administration procedure or to the ziconotide
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From treatment initiation to 2 years of follow-up