The aim of this explorative study is to lay the foundation for investigating the carryover effects in spinal cord stimulation.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the time interval before reactivation of the SCS
treatment (*carryover* / *echo* time) and this parameter will be correlated
with the parameters like: indication, treatment duration, symptom duration,
preoperative pain score, stimulation paradigm, gender, age.
Secondary outcome
na
Background summary
It is a well-known clinical observation that when activating or deactivating
spinal cord stimulation (SCS), there is a variable interval before the patient
perceives a clinical effect of the change. This variation in carryover effects
might be dependent on the clinical condition and/or treatment duration. Very
little research has been published on the topic.
Study objective
The aim of this explorative study is to lay the foundation for investigating
the carryover effects in spinal cord stimulation.
Study design
An open, prospective, explorative, multicenter study
Intervention
Patients will be asked to deactivate their SCS device via their remote control,
switch it back on again when their perceived pain intensity has been increased
with 3 points on a numeric rating scale (0-10) and record the time between
deactivation and reactivation.
Study burden and risks
To our best estimation there are no ethical issues in the study. Turning off
the SCS stimulation is entirely harmless and is being done on a regular basis
by patients themselves and in connection with SCS reprogramming, surgery or
other medical procedures, etc. To our knowledge, no negative side effect
(except an anticipated temporary increase in perceived pain) has ever been
demonstrated with temporary deactivation of SCS treatment. Patients will be
informed that no permanent loss of therapeutic effect has been demonstrated
after temporary deactivation of the device. The patient has full control over
the deactivation/ reactivation of the treatment.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
- patient age minimum 18 years,
- implanted with full SCS system for treatment of neuropathic pain.
- SCS treatment duration minimum 6 months before inclusion.
- maximum pain score 7 or less on a 0-10 NRS at the area of pain treated with SCS during the last 48 hours before study-related deactivation of the device.
- no changes in the programming patterns of the device for a minimum of 30 days before the study-related deactivation of the device.
Exclusion criteria
- surgical SCS lead revision for the last 6 months before inclusion,
- other ongoing neuromodulatory treatment (PNS, TENS, etc.),
- other neuromodulatory treatment with lasting effect (RFA, sympathectomy, infiltration anesthesia, nerve blockade) within the last 60 days,
- changes in medication within the last 30 days (pn. dosings are allowed).
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT03386058 |
| CCMO | NL63846.044.17 |