Assessing the effects of SCS in patients with mononeuropathy measured according to the IMMPACT guidelines (pain reduction, improvement of quality of life, physical and emotional functioning, medication use, adverse events), and assessing the…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect of 6 months of spinal cord stimulation in the test subjects on the
'IMMPACT guidelines' (perceived pain intensity, quality of life, physical and
emotional functioning, and medication use)
Secondary outcome
- Effect of individually optimized spinal cord stimulation settings
- Effect of 3 or 6 months of spinal cord stimulation on thermographic images,
immunology, QST, and EMG.
- Personal preference for spinal cord stimulation settings of the test subjects
Background summary
Peripheral neuropathic pain has a high incidence and prevalence. Damage to a
peripheral nerve has all kinds of causes, for example post-traumatic,
postsurgical, pressure neuropathy, etc. If the pain is in a single nerve, this
is called a mononeuropathy; If it is located in a broader area and involves
several nerves, we call it a polyneuropathy. The pain can be moderate to severe
and significantly impact functionality and quality of life. The regular
treatment of neuropathy is not harmful and highly variable, and the effect of
the treatment is often disappointing. The condition is associated with high
direct and indirect costs.
Several randomized controlled trials have shown that spinal cord stimulation is
an effective treatment for patients with (diabetic) polyneuropathy. For
mononeuropathy, there have been no randomized controlled trials to assess
effectiveness, but there have been a number of case series that positively
assessed spinal cord stimulation for mononeuropathy.
Study objective
Assessing the effects of SCS in patients with mononeuropathy measured according
to the IMMPACT guidelines (pain reduction, improvement of quality of life,
physical and emotional functioning, medication use, adverse events), and
assessing the stimulation paradigm preferences in these patients.
Study design
It is a mono-center exploratory pilot study with at least 12 patients with
peripheral mononeuropathic pain who receive a spinal cord stimulator at Erasmus
MC.
Intervention
Spinal cord stimulator implantation and 3 times blood collection
Study burden and risks
Burden: at least 8 appointments and examinations per subject. Subject must keep
a pain diary for 6 months. Recovery after spinal cord stimulation implantation
can also be painful.
Risk: risk that spinal cord stimulation does not (sufficiently) reduce pain.
Negligible risk of the measurements. Risk of infection or complication after
spinal cord stimulation implantation.
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Suffering from painful peripheral mononeuropathy in the distal extremities,
preferably post-traumatic or post-surgical, confirmed by EMG
- Symptoms refractory to conventional medical management for at least 6 months
according to treating physician
- 18 years or older
- At least 5 out of 10 on the numerical rating scale for pain (average pain
intensity in week prior to assessment)
Exclusion criteria
- Mononeuropathy located in the head or torso
- Mononeuropathy by avulsion at the plexus brachialis
- Life expectancy <1 year
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85325.078.23 |