Back Pain
Conditions
Brief summary
Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain
Detailed description
Facet joint pain encompasses a significant portion of the possible sources of pain in patients with vertebrogenic algic syndrome.A typical symptom caused by facet joint irritation of the medial branch nerve is a back pain with intermittent irregular patchy pain spreading to the legs. The cause of this pain is irritation of the medial branch of the dorsal nerve root which innervates a facet joint. Confirmation of the source of the pain involves local anaesthetic blocks of the medial nerve branches in several adjoining vertebral areas. If this test is positive, then the patient's condition is indicated for radiofrequency ablation or cryoablation of the nerve branches. Description of interventional procedures: Patients with chronic low back pain with confirmed zygapophysial joint pain after previous two medial branch nerve blocks with positive results are indicated for radiofrequency medial neurotomy or alternative cryoablation neurotomy. Navigation with probes in both cases is arranged and directed according to fluoroscopic imaging.
Interventions
The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy
The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy
PROCEDUREEndoscopic denervation of fazet joint
The procedure is based on positive lumbar Z- joint testing followed by decapsulation of the facet joint through an endoscopic approach
Sponsors
EPC Education s.r.o.
Slovak Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
sealed envelope, random software
Intervention model description
Prospectively randomized patients with positive facet joint syndrome
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients aged between 20 and 80 * positive two medial branch nerve blocks with pain relief over 80% during the first 12 hours after nerve block application * positive patient history of facet joint pain * patients with chronic low back pain for at least 6 months with back pain and leg pain (VAS \>=5) * those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form
Exclusion criteria
* patients with a history of other spinal diseases (compression fracture, spondylitis, tumor) * women with positive a pregnancy tests before the trial or who planned to become * pregnant within the following 3 years * other patients viewed as inappropriate by the staff * disagreement with participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 36m | 36 months follow-up | EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression |
| Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 12m | 12 months follow-up | EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression |
| Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 12m | 36 months follow-up | Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 12m measured by VAS 10 point measurement |
| Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 36m | 36 months follow-up | Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 36m measured by VAS 10 point measurement |
| Oswestry Disability Index (ODI) 12m | 12 months follow-up | The ODI self-administered questionnaire measuring 0-100 scale |
| Oswestry Disability Index (ODI) 36m | 36 months follow-up | The ODI self-administered questionnaire measuring 0-100 scale |
Countries
Slovakia
Contacts
STUDY_CHAIRMD, PhD, FIPP Rapcan, MD, FIPP
R-Clinic Bardejov, Slovakia, 085 01
Outcome results
None listed