Prognostic Factors in Zygapophyseal Osteoarthritis Infiltration: a Prospective Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Israelita Albert Einstein
About this trial
Magnet Resonance Image findings of facet osteoarthritis and patient characteristics are prognostic factors for improving or worsening the clinical outcome after treatment with facet infiltration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Older than 18 years;
Fluent or native Portuguese language speaker;
Continuous or intermittent low back pain for at least three months;
Low back pain with or without irradiation to the gluteal region indicating facet syndrome (pain is aggravated by spine extension or bending toward the affected side; pain is exacerbated by prolonged sitting or walking up steps, as well as retaining one position for a prolonged time);
Disqualifiers
Younger than 18 years old,
Symptomatic lumbar spinal stenosis with claudication or radiculopathy;
Evidence of radiculopathy;
Active rheumatologic diseases;
Trial population
All patients seen at the spine outpatient clinic of a tertiary hospital with clinical diagnosis of low back pain of facet origin will be eligible to participate in the study
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
147 Participants
are grouped into 2 trial groupsGroup A: facet inflammatory signs
Group B: no facet inflammatory signs
Trial outcomes
Primary outcomes
1
Change in Roland Moris Questionnaire
functional disability
Time frame
Change from baseline to 1 month, to 3 months, to 6 months, and to 12 monthsSecondary outcomes
1
Change in Visual Analogue Pain Scale (VAS)
pain
Time frame
Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months2
Change in Oswestry Back Pain Disability
functional disability
Time frame
Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months3
Change in EuroQol questionnaire (EQ-5D)
quality of life
Time frame
Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months4
Reduction in pain medication usage
indirect sign of improvement or worsening of pain
Time frame
Change from baseline to 1 month, to 3 months, to 6 months, and to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov