The aim of the research is to study the effectiveness of PRF treatment on radicular neuropathic pain. The effectiveness will be determined by eQST, VAS and RAND-36 values. To evaluate the effectiveness of the PRF treatment, there will be included a…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Electrical sensation thresholds before and after PRF treatment
Secondary outcome
VAS score, symptoms of pain (pain detect), medication use, HADS and RAND-36
questionnaire
Background summary
Chronic radicular neuropathic pain originating from lumbar or sacral nerve root
is a common neuropathic pain and in some cases difficult to treat. Currently
pulsed radiofrequency (PRF) is applied on the dorsal ganglion (DRG) to patients
with refractory radicular neuropathic pain. The effectiveness of a PRF
treatment is currently determined by a VAS score. A VAS score is subjective. A
more objective measurement of pain is desired, this can be by means of electric
quantitative sensory testing (eQST). eQST would serve as a measure for
different nociceptive sensory and neurophysiological processes.
Study objective
The aim of the research is to study the effectiveness of PRF treatment on
radicular neuropathic pain. The effectiveness will be determined by eQST, VAS
and RAND-36 values. To evaluate the effectiveness of the PRF treatment, there
will be included a control group.
There will also be investigated the correlation between VAS and eQST values
and whether the pre-measured eQST could predict the effect of the PRF.
Study design
Prospective intervention study in which patients with radicular neuropathic
pain will be followed over time from the PRF treatment till 8 weeks after the
PRF treatment. Measurments take place on 4 moments: before (baseline) the PRF
treatment, 30 minutes after (follow-up 1) the PRF treatment , 1 week (follow-up
2) and 8 weeks (follow-up 3) after PRF treatment.
Study burden and risks
A low impact, short-term method is chosen for the eQST. The eQST measurements
occur during treatment visits and during visits on the pain policlinic, so the
patients need to come only 4 time extra for the eQST measurement. In total the
patient gets 7 times a eQST measurement. The risks are negligible to mention.
In addition, the used eQST method is non-invasive and takes little time to
complete the measurement. The psychological and physical stress level of fill
in the questionnaires is judged to be low. These questionnaires are regularly
in daily clinical practice and can be performed quickly and efficiently. The
questionnaires are: VAS score, symptoms of pain (pain detect), medication use
and RAND-36 questionnaires and one time the HADS.
Haaksbergerstraat 55
Enschede 7513 ER
NL
Haaksbergerstraat 55
Enschede 7513 ER
NL
Listed location countries
Age
Inclusion criteria
-Subjects should have lumbar of sacral radicular neuropathic pain in dermatome L4, L5 or S1 where the pain is limited for 1 dermatome for at least 3 months. The subjects should have a pain reduction of minimum 50% with a VAS score from 0 to 10 after a diagnostic block.
- Subject is between 18 and 75 year
- Subject has a pain score of 4 or above (visual analog scale, VAS: 0-10 from no pain to worst pain).
- Subject has no new pain medication 2 weeks before the treatment.
- Informed consent.
Exclusion criteria
- Subject has sensory deficits at the QST site resulting from such medical conditions such as diabetes, alcoholic neuropathy, AIDS neuropathy, severe thyroid, liver or kidney diseases.
- Former PRF and RF treatment of the same nerve root.
- Subject has scar tissue, infection, or acute injury at the QST site.
- Language barriers and other problems impairing the reliable completion of questionnaires.
- Subject is pregnant.
- Subject has a pacemaker.
- Subject has a major psychiatric disease or dementia.
- History of back surgery.
- Other chronic pain (such as fibromyalgia).
- Anticoagulation in form of vitamin K antagonists which should not be stopped.
- Skin diseases (such as herpes zoster, burns etc.)
- Allergy for contrast or lidocaine
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| Other | 3763 |
| CCMO | NL42777.044.12 |