Facet joint pain
Conditions
Interventions
This is a randomized controlled two-arm double-blind clinical trial composed of forty participants allocated into two groups of twenty participants each through a computer-generated random sequence wi
blinding will be applied so that both the participant and the evaluator responsible for outcome assessment remain unaware of group allocation, while only the physician performing the infiltration proc
Sponsors
HOME - Hospital Ortopédico e Medicina Especializada - LTDA
HOME - Hospital Ortopédico e Medicina Especializada - LTDA
Eligibility
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants aged eighteen years or older; chronic low back pain refractory to conservative treatment, including failure to respond to simple analgesics, nonsteroidal anti-inflammatory drugs, and adjunct therapies such as physical therapy and acupuncture; positive diagnostic test for facet syndrome, including worsening of low back pain during trunk extension after diagnostic facet block with lidocaine and pain relief equal to or greater than fifty percent on the visual analog scale within four hours after the block; confirmed diagnosis of facet syndrome by magnetic resonance imaging demonstrating facet arthritis or arthrosis
Exclusion criteria
Exclusion criteria: Presence of preexisting neurological deficit; rheumatologic disease; coagulopathy; pregnancy; allergy to local anesthetics; contraindication or adverse effects related to corticosteroid use; previous lumbar spine surgery; lumbar tumor; spondylolisthesis; low back pain without an identifiable cause
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in the intensity of low back pain assessed by the Visual Analog Scale is expected, as well as an improvement in functionality assessed by the Oswestry Disability Index questionnaire, with a clinically significant difference between baseline and the follow-up assessments at one, seven, thirty, ninety, and one hundred eighty days after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| A low frequency of adverse events and complications is expected, assessed through identification, classification, and clinical monitoring of events during the baseline period and at one, seven, thirty, ninety, and one hundred eighty days after the procedure in both groups. Greater clinical satisfaction is expected in the experimental group compared with the control group according to the MacNab criteria, assessed by the clinical response classification at the same follow-up time points | — |
Countries
Brazil
Contacts
Public ContactDiovanni Pereira
HOME - Hospital Ortopédico e Medicina Especializada - LTDA
Outcome results
None listed