NL-OMON43640
Completed
Not Applicable
Spinal Cord Stimulation in Small Fibre Neuropathy: A pilot study - SFN-SCS Study
Medisch Universitair Ziekenhuis Maastricht0 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- painfull neuropathy
- Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •SFN\-diagnosis
- •age between 18 and 75 years
- •mean pain intensity 5 or higher on the 11 points numeric rating scale (NRS
- •pain present for more than 12 months
- •previous treatment unsuccessful with drugs from the following drugs: tricyclic antidrepressant agent, alpha 2 adrenergic calcium channel agonist/anti\-epileptic drug, serotonin\-norepinephrine reuptake inhibitor, tramadol or strong opioids
- •Steady state medication use for at least 2 months
Exclusion Criteria
- •neuromodulation in history
- •neuropathic pain prevalent in upper limbs exceeding NRS 3
- •neuropathy or chronic pain of other origin than SFN (NRS \>3\)
- •insufficient cooperation from the patient
- •bloth clothing disorder
- •immune deficiency
- •known peripheral vascular disease
- •life expextancy \< 1 year
- •local infection or other skin disorders at site of incision
- •other clinical or unstable, or severe acute or chronic medical or psychiatric/psychological condition or laboratory abnormality that may increase the risk associated with study participation or procedure or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study
Outcomes
Primary Outcomes
Not specified
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