• To evaluate patient pain and comfort level under spinal or local anaesthesia during SCS trial lead implantation.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Chronic pain as a result of FBSS
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Subject experience will be evaluated using a numerical pain rating scale
(NPRS) to assess the degree of pain/discomfort during the lead implantation
procedure. A clinically meaningful difference in NPRS is set at two points on
the NPRS scale (0-10)
Secondary outcome
• To evaluate the difference in amount of medication for sedation required,
including additional pain medication. Dosages administered will be captured
during procedure.
• Physician and patient satisfaction will be evaluated using a 5-point Likert
scale.
• The effects of spinal and local anaesthesia on ECAP generation will be
assessed in the following ways. These evaluations will take place
intra-operatively, post-operatively in the recovery room (<1 hr post-procedure)
and on the morning following the lead or IPG implantation procedure:
o As to whether or not ECAPs can be generated a simple Yes/No question will be
answered.
o An activation profile will be created to describe the relationship between
device output and spinal cord activation - the values for this activation
profile and subject sensitivity will be captured.
o Conduction velocity (CV) evaluations will be performed using software on the
CL-SCS system.
• Effects of posture on ECAP recordings will be assessed by repeating the
activation profile exercise in the supine, sitting and standing positions. This
will only be conducted after anaesthesia has fully washed out (only performed
one day after implantation).
• Pain relief will be assessed by comparing baseline pain intensity to that
reported at the end of the SCS trial period using a numeric pain rating scale
(NPRS).
• The effect of general anaesthesia on ECAP will be evaluated by performing a
CV evaluation intra-operatively during permanent IPG implantation and
post-operatively when subjects are fully awake using software on the CL-SCS
system.
Background summary
Spinal Cord Stimulation (SCS) has been used successfully to treat FBSS patients
for fifty years now. Usually the SCS is implanted under local anaesthesia with
or without sedation (propofol), In the Elisabeth Tweesteden Hospital (ETZ)
Tilburg the procedure is usually performed successfully under spinal
anaesthesia for a few years now. Up until today there is no published data on
the utility of using spinal anaesthesia during SCS procedures.
Study objective
• To evaluate patient pain and comfort level under spinal or local anaesthesia
during SCS trial lead implantation.
Study design
Prospective randomised, double-arm, open label exploratory trial designed to
investigate patient experiences of spinal or local anaesthesia during SCS trial
lead implantation.
Intervention
one group will recieve spinal anesthesia during implantation of de electrodes,
the other group recieves local anaesthesia with sedation.
Study burden and risks
Burden and risks
There are only minor additional risks to participation in this study. The
implantation of the system is a standard procedure in the hospital and the data
that is collected consists of questionnaires regarding satisfaction, pain
intensity and pain relief, subject satisfaction, and stimulation induced
sensation.
Data collection activities will add approximately 10 to 30 min to the normal
length of time required depending on the number of tests conducted during the
visit.
Benefit and group relatedness
There will be no immediate benefit to study participants. However, the results
of this study may add to the knowledge on the use of spinal or local
anaesthesia and subjects experience with these alternative methods. This
information will hopefully inform future trial design and lead to improved
treatment for patients undergoing SCS lead implantation. While the sample size
for this pilot study is not powered we believe that a sufficient sample size
has been identified to enable the design of a future randomized controlled
trial (RCT) to confirm or contest preliminary findings from this study.
Hilvarenbeekseweg 60
Tilburg 5022 GC
NL
Hilvarenbeekseweg 60
Tilburg 5022 GC
NL
Listed location countries
Age
Inclusion criteria
• Subject has been diagnosed with chronic, intractable leg and/or back pain
(NPRS >= 6), FBSS, which has been refractory to conservative therapy for at
least 6 months.
• Subject has been approved by the Investigator to undergo a trial of SCS
implantation.
• Subject is an appropriate candidate for the surgical procedures required for
SCS based on the clinical judgment of the implanting physician.
• Subject is on a stable dose (no new, discontinued, or changes in dose) of all
prescribed pain medication for at least 30 days prior to baseline evaluation.
• Subject is willing and capable of giving written informed consent.
• Subject is willing and able to comply with study-related requirements,
procedures, and visits.
• Subject is at least 18 years of age
Exclusion criteria
• Subject has a medical condition or pain in area(s) that could interfere with
study procedures, accurate pain reporting, and/or confound evaluation of study
endpoints, as determined by the Investigator.
• Subject is not an SCS candidate due to anatomical or structural findings
and/or changes which would benefit from surgical intervention as determined by
the Investigator.
• Subject has evidence of an active disruptive psychological or psychiatric
disorder or other known condition significant enough to impact perception of
pain, compliance with intervention and/or ability to evaluate treatment
outcomes as determined by the Investigator.
• Subject who has had another neuromodulation system.
• Subject has a condition currently requiring or likely to require the use of
MRI or diathermy.
• Subject is not a good surgical candidate (e.g., has an uncontrolled
coagulation disorder, bleeding diathesis, progressive peripheral vascular
disease, uncontrolled diabetes mellitus, or cannot come off anticoagulant
therapy for procedure).
• Subject is concomitantly participating in another clinical study unless
pre-approved by the principal investigator.
• Subject is involved in a process (e.g., involved in an injury claim under
current litigation) in which pain relief may be considered detrimental (i.e.,
secondary gains).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL75858.028.20 |
| OMON | NL-OMON20564 |