Status:
TERMINATED
Comparative Study in Patients With Refractory Chronic Lower Limb Neuropathic Pain and/or Back Neuropathic Pain.
Lead Sponsor:
Poitiers University Hospital
Conditions:
Pain, Neuropathic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Neuropathic pain is described as a "pain initiated or caused by a primary lesion or dysfunction in the nervous system". It is thus often a chronic affection, as a difficult-to-treat condition. As such...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subject has ≥ 18 years and ≤ 80 years
- Subject has a VAS ≥ 5
- Subject has refractory chronic lower limbs neuropathic pain (e.g. diabetic foot peripheral neuropathy, foot peripheral neuropathy, ankle peripheral neuropathy) or/and neuropathic back pain for at least 6 months
- Subject has stable pain for at least 30 days
- Pain medication(s) dosage(s) is/are stable for at least 30 days
- Subject is refractory to other treatment modalities (e.g. Medication, psychological therapies, pain interventions, surgery)
- Subject is eligible for SCS after a pre-implantation assessment by a multidisciplinary team, as described by the French National Authority for Health
- Subject understands and accepts constraints of the study.
- Patient covered by French national health insurance.
- Subject has given written consent to the study after having received clear and complete information
- Non inclusion criteria:
- Subject has a coagulation disorder
- Subject is or has been treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system
- Subject has had corticosteroid therapy within the past 30 days
- Subject has had radiofrequency therapy within the past 3 months
- Subject has been diagnosed with cancer in the past 2 years
- Subject has had a spinal surgery within the past 6 months
- Subjects requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patients in an emergency setting
- Simultaneous participation to any interventional study on health product or any study able to interfere with the current study endpoints.
- Pregnant or breastfeeding women, women at age to procreate and not using effective contraception
- Brain MRI contraindication
Exclusion
Key Trial Info
Start Date :
August 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04852107
Start Date
August 20 2021
End Date
December 15 2022
Last Update
January 13 2023
Active Locations (1)
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1
Poitiers University Hospital
Poitiers, France, 86021