AI-Powered Research

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)
addiction
insufficient cooperation from the patient
bloth clothing disorder
immune deficiency
known peripheral vascular disease
life expextancy < 1 year
pacemaker
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
pregnancy
severe cardiac or pulmonary failure
use of opioids

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Clinically significant pain relief in patients suffering from pain in the lower<br /><br>limbs due to SFN, defined as 50% pain reduction on a mean NRS during daytime,<br /><br>and/or 50% pain reduction on a mean NRS during night-time and/or 2 points<br /><br>difference (much improved or very much improved) on the Patient Global<br /><br>Impression of Change (PGIC) for pain and sleep. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are to investigate:<br /><br>1) The effect of SCS on pain in SFN (pain reduction of *30% on a mean daytime,<br /><br>night-time, and maximum daily pain (tested separately) using the NRS );<br /><br>2) The effect of SCS on activity/participation in SFN;<br /><br>3) The effect on health related quality of life (QoL) in SFN;<br /><br>4) The effect of SCS on mood in SFN;<br /><br>5) The effect of SCS on the reduction of pain medication in SFN.</p><br>