Understanding factors affecting treatment outcomes in lumbar spine osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the prognostic factors associated with treatment outcomes for patients suffering from degenerative arthropathy of the lumbar spinal facet joint. It focuses on the relationship between magnetic resonance imaging findings of facet osteoarthritis and patient characteristics to predict clinical outcomes following facet infiltration treatment. The study aims to enhance diagnostic accuracy and treatment effectiveness for low back pain, a prevalent health issue affecting a significant portion of the population. Participants will be assessed based on their pain characteristics and treatment history to identify factors that may influence their recovery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Israelista Albert Einstein
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Joao C Rodrigues, MD — Hospital Israelita Albert Einstein
• Study coordinator: Joao C Rodrigues, MD
• Email: joao.rodrigues@einstein.br
• Phone: 551121512452

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.