painfull neuropathy
Conditions
Interventions
Patients will receive SCS, with first 2 weeks of trial stimulation and best
(drug) treatment as usual.
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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) addiction insufficient cooperation from the patient bloth clothing disorder immune deficiency known peripheral vascular disease life expextancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically significant pain relief in patients suffering from pain in the lower limbs due to SFN, defined as *50% pain reduction on a mean NRS during daytime, and/or *50% pain reduction on a mean NRS during night-time and/or 2 points difference (much improved or very much improved) on the Patient Global Impression of Change (PGIC) for pain and sleep. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are to investigate: 1) The effect of SCS on pain in SFN (pain reduction of *30% on a mean daytime, night-time, and maximum daily pain (tested separately) using the NRS ); 2) The effect of SCS on activity/participation in SFN; 3) The effect on health related quality of life (QoL) in SFN; 4) The effect of SCS on mood in SFN; 5) The effect of SCS on the reduction of pain medication in SFN. | — |
Countries
Netherlands
Outcome results
None listed