To evaluate the effect of PRF treatment adjacent to the lumbar dorsal root ganglion (DRG) of L5 or S1 in patients with a chronic LRS.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary research question is to evaluate the extent of additional pain
reduction induced by PRF, compared with the control group. Following evaluation
tools are used: Visual Analogue Scale 8, Global Perceived Effect on Likert
Scale, consumption of pain medication, neuropathic pain scales: LANSS and
DN-4.
Secondary outcome
Secondary parameters are quality of life measured by RAND 36, disability
measured with the Oswestry disability Index.
A sub-analysis will be conducted to evaluate a potential correlation between
diagnostic block and outcome of PRF treatment. Another sub-analysis will be
conducted to evaluate a potential correlation between the neurological tests
described in this study and the outcome of PRF treatment.
Background summary
Lumbosacral radicular syndrome (LRS) is probably the most frequent neuropathic
pain syndrome, however the available evidence for currently used treatments is
scares. The beneficial effect of pulsed radiofrequency (PRF) treatment has been
described for the management of LRS in case reports, retrospective and
prospective studies.
Study objective
To evaluate the effect of PRF treatment adjacent to the lumbar dorsal root
ganglion (DRG) of L5 or S1 in patients with a chronic LRS.
Study design
Prospective multicenter clinical trial. The study will be performed in third
line referral centers. Conventional medical management will be optimized in all
patients during at least 1 month. The patients who still have a pain score for
their leg pain >5 (VAS) are candidates for the PRF study. After informed
consent, the patients receive a diagnostic block and treatment with PRF.
Intervention
Initially conventional medical management (CMM) will be optimized in all
patients during at least one month. All applicable patients, with NRS score
above 5, will receive PRF treatment adjacent to the DRG of L5 or S1
additionally to CMM, after a diagnostic block. When no satisfaction in
painreduction is reached (after 6 weeks) a second PRF treatment is possible.
The second group (Control group) will continue CMM during the study period.
Study burden and risks
Patients will undergo a neurologic examination before and 4 weeks after the
intervention; this will be repeated at 3 and 6 months if abnormalities are
observed. At each of these time points the patients will receive questionnaires
to fill out. In total 4 times. The PRF group will first receive a diagnostic
block.
Possible Risks:
A puncture of a blood vessel is possible, diagnosed by injection of contrast,
for which repositioning of the needle is needed.
Should accidental intravascular injection of local anesthetic occur, the dose
used is low and reports show that intravascular injection of lidocaine 20mg
does not pose clinical problems.
The dura can be punctured; as a consequence contrast will flow in the
cerebrospinal fluid. The procedure will be stopped and repeated after a few
days.
In theory a lesion of the nerve root is possible, but the needles are designed
to avoid this, this complication has not been seen since more than 10 years.
Up till now, a transient pain is occasionally described after the PRF
treatment.
No hypoesthesia or motor complications were reported.
So the risks are negligible and the procedures are well tolerated.
P. Debyelaan 25
6229 HX Maastricht
NL
P. Debyelaan 25
6229 HX Maastricht
NL
Listed location countries
Age
Inclusion criteria
* Symptoms more than 3 months;
* Pain radiating into the leg, up to the hallux (big toe) (L5) or little toe (S1),
* The pain in the leg dominates over a possible lumbalgia, the average pain in the leg measured 3 times a day, at predefined time points, over 4 consecutive days prior to inclusion should be more than 5 (VAS 10-point scale) 9,
* Pattern of radiation suggestive for L5 or S1 pathology 49,50,
* One or more positive neurological tests of nerve root tension or neurological deficit 51 (straight leg raising test (SLRT), contralateral SLRT, motor block during SLRT and passive cervical flexion, motor reaction during passive cervical flexion while bending forward in standing position),
* Capable of understanding the information relative to the treatment and procedure and willing to provide informed consent,
* Capable of understanding and filling-out the questionnaires necessary for evaluation of the treatments,
* Patients having undergone low back surgery like discectomy with or without laminectomy are allowed to participate in the study.
Exclusion criteria
* Patients younger than 18 years,
* Malignant disorder or currently under treatment for a malignant disorder,
* Previous lumbar fractures,
* Proven myelum lesion or abnormalities in the central neurological structures,
* Systemic or connective tissue diseases,
* Diabetes mellitus type I,
* Multiple sclerosis,
* Coagulation disorders,
* Pregnancy,
* Pain Catastrophizing Scale > 45. When the patient has a higher score he/she will first be referred to a psychologist for consultation 52,
* Leg pain due to localized hip or knee pathology,
* Patients with a pacemaker or neurostimulator,
* Patients previously treated with RF or PRF of the lumbar DRG.
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 | NL28367.068.09 |