Investigate the value of percutaneous radiofrequency heat lesion applied to the ramus communicans; 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…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc 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
Chronic low back pain is the biggest factor limiting activity in young adults
under the age of 45. Discogenic pathology is estimated to be responsible for
chronic low back pain between 7% and 39% in several studies. Degenerative
changes can give rise to the existence of pain. Discogenic low back pain
problems require the presence of free nerve endings and inflammation; a high
concentration of nerves and vessels is present in the outer third of the
annulus and the endplate adreas, likely the sites where pain is produced.
Several treatment options have been developped for providing a significant pain
reduction, evidence (weak) does exist for IDET, radiofrequency annuloplasty,
TDD and radiofrequency denervation of the ramus communicans.
Study objective
Investigate the value of percutaneous radiofrequency heat lesion applied to the
ramus communicans; 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 (80°C, 60 sec) at the
ramus communicans; 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
Minimally invasive treatments provide alternatives for discogenic pain with the
appeal of cost-effectiveness and, possibly, less long-term side effects. No
major complications are reported with treatment of the ramus communicans.
'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 discogenic pain on lumbar level
3) Decrease in NRS of 2 or more / 10 on diagnostic ramus communicans 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 | NL36869.078.11 |