The primary objective of this study is to investigate attenuation of pain and sensory thresholds during dorsal root ganglion stimulation using QST. The secondary objectives of this study are to investigate 1) To assess changes in pain intensity (NRS…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quantitative Sensory Testing:
* pQST
o Pressure Pain Detection Threshold (PPDT) (N)
* eQST
o Electrical Pain Detection Threshold (EPDT) [mA]
o Electrical Pain Tolerance Threshold (EPTT) [mA]
* Nociceptive Perception thresholds (NPT)
o Stimulus amplitude [mA]
o Responses to stimuli (perceived / not perceived)
o Stimulation time [s]
Secondary outcome
Pain intensity
* Initial pain intensity (NRS; (total population as mean ± SD) *SCS-OFF*
* Pain intensity (NRS; total population as mean ± SD) *SCS-ON*
* Mean (% ± SD) pain reduction during SCS
* Questionnaires
o Brief Pain Inventory
Subjects characteristics
* Age, sex, BMI, ASA classification, smoking habits
o Pain history (duration, intensity etc)
o Medication (i.e. acetaminophen, NSAID*s, opioids)
o Area of paresthesia
* Neurological examination
Background summary
Severe leg pain after back surgery (Failed Back Surgery Syndrome) of after
nerveinjury due to trauma/surgery (CRPS) which is refractory to conservative
treatment can be treated with spinal cord stimulation. Several studies showed
SCS (in particular dorsal root ganglion stimulation) is effective to reduce
pain in FBSS and CRPS patients. Despite promising clinical results, underlying
mechanisms of action of SCS are still largely unknown. Quantitative sensory
testing (QST) contain psychophysical methods which are used for systematic
documentation of alterations and reorganizations of the nociceptive system.
Estimation of nociceptive thresholds (e.g., detection threshold or pain
threshold) using various modalities (e.g., electrical or mechanical) allow
observation of sensory processing under normal and pathophysiological
conditions. This pilot study uses quantitative sensory testing (QST) to
objectively quantify the impact of SCS on pain and sensory thresholds over the
painful area covered by the SCS-related paresthesia compared to findings of a
non-painful area with the same subject (no SCS-related paresthesia) and a
healthy control group.
Study objective
The primary objective of this study is to investigate attenuation of pain and
sensory thresholds during dorsal root ganglion stimulation using QST. The
secondary objectives of this study are to investigate 1) To assess changes in
pain intensity (NRS) when SCS is activated (SCS-on) as compared to a *SCS-off*
period. 2) To assess the correlation between pain ratings using numeric rating
scores (NRS) and pain/sensory thresholds with SCS-off and SCS-on.
Study design
single-center, single-arm, observational pilot study.
Study burden and risks
This is a observational study without experimental intervention. The risks are
believed to be minimal (minor skin irritation due to ECG and needle electrodes,
which resolves spontaneously). After signing the informed consent form,
subjects will have a single test session at the Pain Clinics. The medical
centre visit is planned on a day where subjects are already scheduled for a
regular visit. Several Quantitative Sensory Testing will be performed, and
questionnaires filled in by all subjects. All measurements are non-invasive.
The total duration of the study is 60 minutes (healthy control group: 25min).
The participating subjects will obtain no direct personal benefit.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
- Patients aged 18-55years
- Patients diagnosed with the Failed Back Surgery Syndrome or Complex Regional Pain Syndrome
- Unilateral leg pain
- A spinal cord stimulator was implanted recently ( at least 1 month ago)
Exclusion criteria
- Patient refusal
- Diabetes
- Pre-existing neurological- of psychiatric disease
- Alcohol- of drug abuse
- Difficulties in communication
- Recent therapies that influence QST measurements, i.e. neuroablative procedures within 2 months
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 |
|---|---|
| CCMO | NL54728.100.15 |