Aim of the study is to evaluate if the optical tissue stylet technology can discriminate tissues that are relevant to recognize for interventional pain procedures.
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the trial is to explore differences in the optical
signals obtained in tissues encountered along the needle trajectory during
image-guided interventional pain procedures.
Therefore, successful acquisition of optical spectra at well-defined points
during the image-guided interventional pain procedures is the primary study
parameter.
The primary objective of the trial is to explore differences in the optical
signals obtained in tissues encountered along the needle trajectory during
image-guided interventional pain procedures.
Therefore, the primary study parameters are:
1. Successfully acquired diffuse reflectance spectra obtained in subcutaneous
fat, muscle, fascia, and the adipose tissue surrounding the target nerve.
2. Confirmation images by ultrasound, fluoroscopy, and the electrical
stimulation threshold levels obtained at the locations where the diffuse
reflectance spectra have been collected
3. the *certainty score* on a 3-point scale provided by the physician for
assignment of the type of tissue present at the needle tip, based on the
information available from imaging and/or electrical stimulation
Secondary outcome
not applicable
Background summary
For effective interventional pain treatments, correct needle placement is
crucial. Therefor, currently, needle placement is done under image-guidance,
and the actual treatment location is confirmed with electrical stimulation
before the treatment takes place. However, accuracy of needle placement could
still be improved if information would be available that would complement the
current imaging and electrical stimulation methods. We have developed a system
based on optical spectroscopy that has the potential to provide such
complementary information.
This study will be an observational study in a limited number of patients.
Special sterile optical tissue stylets have been made, that fit into the lumen
of the needles that are normally used for treatment. A set of image-guided
interventional pain procedures has been selected, during which diffuse
reflectance spectra will be acquired with the optical tissue stylets, at a
number of points along the needle trajectory that allow for confirmation by
imaging and/or electrical stimulation.
We will investigate whether the optical tissue stylet technology provides
information relevant for identifying specific tissue transitions. In case of
positive results of this feasibility study, additional studies will be set up,
for instance to explore whether providing the optical tissue stylet data to the
physician during a procedure results in improved procedure outcome.
The procedures during which data will be obtained are currently common clinical
practice. This study will not increase the number of interventional pain
procedures performed or the number of patients undergoing a certain procedure,
since subjects will be included who have been scheduled to undergo the selected
procedure irrespective of the study.
During the observational study, data collected by the system will not be
provided to the physician during the procedures, as we intend to influence the
course of the procedure as little as possible.
Study objective
Aim of the study is to evaluate if the optical tissue stylet technology can
discriminate tissues that are relevant to recognize for interventional pain
procedures.
Study design
This is a nonrandomized controlled observational study, conducted in a single
center to evaluate the potential of diffuse reflectance spectroscopy
measurements to identify tissues at the tip of a needle during image-guided
interventional pain treatments
Study burden and risks
The procedures during which data will be obtained are currently common clinical
practice. During the observational study, data collected by the system will not
be provided to the physician during the procedures, as we intend to influence
the course of the procedure as little as possible. We foresee that in order to
collect the diffuse reflectance spectra, it will be required to perform the
procedures at a slower pace than normal. The expected maximum procedure
lengthening is 20% of normal procedure duration, up to a maximum procedure
lengthening of 5 minutes, which is clinically acceptable. Subjects who
participate in the test will not be exposed to additional risks. They will
experience minimal discomfort.
High TEch Campus 34
5656 AE
Nederland
High TEch Campus 34
5656 AE
Nederland
Listed location countries
Age
Inclusion criteria
Patients that fall into one of the following classes:
A. Neuralgia paraesthetica patients for whom the indication of a blockade of the nervus cutaneus femoris lateralis has been made.
B. Patients experiencing pain in the groin area, for whom the indication of a blockade of the nervus ilioinguinalis, nervus iliohypogastricus, or nervus genitofemoralis, nervus femoralis, nervus ischiadicus, nervus peroneus, nervus tibialis anterior, nervus saphenus, nervus suralis, nervus pudendus and has been made.
C. Patients experiencing pain in the arm and neck area, for whom the indication of a blockade of the nervus auricularis magnus and plexus brachialis (nn radialis, ulnaris, medianus) has been made.
D. Patients experiencing discogenic lower back pain, which have been indicated for a blockade of the communicating ramus.
E. Patients who have been indicated for a sympathetic blockade either because of a complex regional pain syndrome, or because of a peripheral vascular disease.
Exclusion criteria
- patients that undergo photodynamic therapy
- pregnancy
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 | NL31578.068.10 |
| Other | nog niet bekend - registratie volgt na METC goedkeuring |
| OMON | NL-OMON20744 |