Investigate the value of percutaneous radiofrequency heat lesion, applied to the medial branch of the primary dorsal ramus; more specifically try to determine if a significant and long lasting pain reduction can be obtained as compared to a sham-…
ID
Source
Brief title
Condition
- Joint disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain reduction (NRS).
Secondary outcome
Pain: Chronic Pain Acceptance Questionnaire (CPAQ), Four-Dimensional Symptom
Questionnaire (4DSQ), Multidimensional Pain Inventory (MPI-DLV);
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
Facet joint pain remains a misunderstood, misdiagnosed, and improperly treated
medical condition. Like other synovial joints in the body, the facet joints
represent a potential pain generator in patients with chronic pain. Several
authors proposed that the facet joints were responsible for a significant
amount of low back pain. Numerous reviews have outlined the difficulties in
diagnosing facet joint pain using anamnesis, physical investigation and
radiologic findings and concluded that an analgesic response to image-guided
intra-articular or medial branch block currently is the most reliable and valid
method to identify a facet joint as the primary pain generator. Van Kleef et al
(Van Kleef, 1999) concluded that radiofrequency lumbar facet joint denervation
results in a significant alleviation of pain and functional disability in a
select group of patients with chronic low back pain, both on a short-term and a
long-term basis.
Study objective
Investigate the value of percutaneous radiofrequency heat lesion, applied to
the medial branch of the primary dorsal ramus; 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, controlled, single-blinded, multicenter clinical trial.
Intervention
Group 1 (treatment group): percutaneous RF heat lesion (80º C during 60 sec.
per level) at the medial branches of the primary dorsal rami on three adjecent
levels; group 2 (sham-operated group) same procedure as in group 1 except RF
heat lesion. Both groups will receive graded activity.
Study burden and risks
Fluoroscopically guided percutaneous radiofrequency denervation of the lumbar
facets is associated with an overall 1.0% incidence of minor complications per
lesion site, consisting of localized pain lasting more than 2 weeks and
neuritic pain lasting less than 2 weeks. No major complications seem to be
found (Kornick, 2004), but nevertheless recently a case report was presented
(Kim, 2010) concerning death following lumbar facet joint injection due to
generalized infection.
's-Gravendijkwal 230
3015 CE Rotterdam
NL
's-Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
1) Age 18 years or older
2) Anamnesis and physical investigation suggestive of facet joint pain on lumbar level
3) Decrease in NRS of 2 or more / 10 on diagnostic facet joint medial branch block
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) Lumboradicular syndrome
3) Aspecific low back pain
4) Corpus vertebrae problem
5) Progressive neurological defecits
6) Major psychiatric disorder (according to psychiatrists opinion)
7) Anticoagulation cannot be stopped
8) Active infection
9) Pain in other parts of the body that is more severe
10) Allergies to any medication used in the study
11) Pregnancy
12) 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 | NL36850.078.11 |