Clinical trial: Prognostic Factors in Zygapophyseal Osteoarthritis Infiltration: a Prospective Cohort Study (NCT03304730)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Contradiction