This study is a pilot study to investigate whether Spinal Cord Stimulation (SCS) combined with best (drug) treatment as usual (TAU) leads to clinically significant pain relief in patients suffering from pain in the lower limbs due to SFN, defined as…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Small fibre neuropathy (SFN) is a disorder in which selectively thinly
myelinated and unmyelinated nerve fibres are involved. SFN can cause severe
neuropathic pain in combination with autonomic symptoms. So far, the results
of symptomatic SFN treatment have been rather disappointing, despite the fact
that new agents have been developed.
Study objective
This study is a pilot study to investigate whether Spinal Cord Stimulation
(SCS) combined with best (drug) treatment as usual (TAU) leads to 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.
Study design
The study is a prospective pilot study to investigate the effect of SCS on pain
in SFN.
Intervention
Patients will receive SCS, with first 2 weeks of trial stimulation and best
(drug) treatment as usual.
Study burden and risks
SCS related risks include: lead migration (14%), lead breakage (7%), implanted
pulse generator (IPG) migration (1%), loss of therapeutic effect, unpleasant
paresthesias (12%), infection or wound breakdown (10%), pain at implanted pulse
generator (IPG) incision site (12%), IPG pocket fluid collection (5%).
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P. Debyelaan 25 P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25 P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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)
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53831.068.15 |