investigate the value of percutaneous pulsed radiofrequency, applied to the lumbar and sacral dorsal root ganglion; more specifically try to determine if a significant and long lasting pain reduction can be obtained as compared to a sham-operated…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Numerical Rating Scale (NRS).
Secondary outcome
Pain: Chronic Pain Acceptance Questionnaire (CPAQ), Four-Dimensional Symptom
Questionnaire (4DSQ), Multidimensional Pain Inventory (MPI-DLV); Global
Perceived Effect (GPE).
Disability: Oswestry Disability Index (ODI);
Generic health status: Rand-36;
Kinesiophobia: Tampa Scale for Kinesiophobia (TSK);
Coping: Pain Coping Inventory (PCI), Pain Cognition List (PCL-2003).
Costs of intervention.
Background summary
chronic lumbosacral radicular pain is an important medical and socioeconomic
problem, the major cause of it being stimulation of the nerve root and dorsal
root ganglion (DRG) by disc herniation. Continuous (CRF) and pulsed (PRF)
radiofrequency procedures have been used at the DRG to diminish the radiating
pain; differences between them (electrical and histological - as well as
chemical results) are explained. Several studies show a beneficial result of
PRF at the DRG with no complications; no randomised controlled trial (RCT) has
been conducted.
Study objective
investigate the value of percutaneous pulsed radiofrequency, applied to the
lumbar and sacral dorsal root ganglion; more specifically try to determine if a
significant and long lasting pain reduction can be obtained as compared to a
sham-operated group. In addition to the above a cost analysis will be performed
for each individual treatment as well as for the complete healthcare system.
The results will be used for further studies concerning intervention in spine
related pain disorders.
Study design
randomised, sham-controlled, double-blind, multicenter clinical trial.
Intervention
group 1 (treatment group): percutaneous pulsed radiofrequency treatment (45 V,
2 Hz, 20 ms, 4 minutes, maximum 42º C) at the lumbar and sacral dorsal root
ganglion; group 2 sham-operated group (same procedure as in group 1 except
pulsed radiofrequency). Both groups will receive graded activity physiotherapy.
Study burden and risks
Minimally invasive treatments provide alternatives for lumbosacral radicular
pain with the appeal of cost-effectiveness and, possibly, less long-term side
effects. Up until now no complications from fluoroscopically guided
percutaneous pulsed radiofrequency of the lumbar and sacral dorsal root
ganglion have been reported.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1) Age 18 years or older
2) Anamnesis and physical investigation suggestive of lumbosacral radicular pain for more than 3 months
3) Decrease in NRS of 2 or more / 10 on diagnostic block at the DRG
Exclusion criteria
1) Presence of red flags: possible fracture (major trauma, minor trauma in elderly or osteoporotic), possible tumor or infection (age >50 or <20, history of cancer, constitutional symptoms (fever, chills, weight loss), recent bacterial infection, IV drug abuse, immunosuppression, pain worsening at night or when supine), possible significant neurological deficit (severe or progressive sensory alteration or weakness, bladder or bowel dysfunction, evidence of neurological deficit (in legs or perineum in the case of low back pain)
2) Aspecific low back pain
3) Corpus vertebrae problem
4) Progressive neurological defecits
5) Major psychiatric disorder (according to psychiatrists opinion)
6) Anticoagulation cannot be stopped
7) Active infection
8) Pain in other parts of the body that is more severe (including facet joint -, SI joint - and discogenic pain)
9) Allergies to any medication used in the study
10) Pregnancy
11) Communication (language) difficulties (according to physicians opinion)
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 |
|---|---|
| CCMO | NL43783.078.13 |