Degenerative Arthropathy of Lumbar Spinal Facet Joint Clinical Trial
Official title:
Prognostic Factors of Efficacy in Corticoid and Anesthetic Joint Infiltration for the Treatment of Patients With Low Back Pain Secondary to Zygapophyseal Osteoarthritis: a Prospective Cohort Study
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.
Status | Recruiting |
Enrollment | 147 |
Est. completion date | December 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria The following are inclusion criteria for participants: - 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); - Failure of traditional treatment includes, but is not limited to, physical or drug therapy; - Understand the purpose of the study; - Voluntarily provide a free and informed consent form, by themselves or through their partners, and complete the questionnaires, before undergoing infiltration, over the telephone or online during the follow-up. Exclusion criteria The following are exclusion criteria for participants: - Younger than 18 years old, - Symptomatic lumbar spinal stenosis with claudication or radiculopathy; - Evidence of radiculopathy; - Active rheumatologic diseases; - Congenital or acquired deformities of the lumbar spine; - Fracture or sequel of lumbar spine fracture of traumatic, pathological or osteoporotic origin; - Surgical manipulation of the lumbar spine; - MRI scans of limited quality and incomplete sequences; - Treated with systemic steroids less than one month before the IFI; - Treated with IFI with steroids within the last six months; - Diagnosed with uncontrolled diabetes mellitus; - History of allergy to anesthetics or adverse reaction to steroids; - Pregnant women or women who breastfed; - Who could not be contacted over the phone during follow-up. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Israelista Albert Einstein | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Hospital Israelita Albert Einstein |
Brazil,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Roland Moris Questionnaire | functional disability | Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months | |
Secondary | Change in Visual Analogue Pain Scale (VAS) | pain | Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months | |
Secondary | Change in Oswestry Back Pain Disability | functional disability | Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months | |
Secondary | Change in EuroQol questionnaire (EQ-5D) | quality of life | Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months | |
Secondary | Reduction in pain medication usage | indirect sign of improvement or worsening of pain | Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months |