Understanding factors affecting treatment outcomes in lumbar spine osteoarthritis

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

This study is trying to see how different factors, like MRI results and patient history, can affect how well treatment works for people with low back pain caused by arthritis in the spine.

Quick facts

• Study type: Observational
• Enrollment: 147 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Israelita Albert Einstein (other)
• Drugs / interventions: radiation
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT03304730 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with persistent low back pain for at least three months, particularly those who have not responded to traditional treatments.

Not a fit: Patients with symptomatic lumbar spinal stenosis or those under 18 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with low back pain due to facet osteoarthritis.

How similar studies have performed: While similar studies have explored treatment outcomes for low back pain, this specific approach focusing on prognostic factors in facet osteoarthritis is relatively novel.

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.

Where this trial is running

São Paulo, São Paulo

• 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

Conditions: Degenerative Arthropathy of Lumbar Spinal Facet Joint, Zygapophyseal Joint, Low Back Pain, Spine Osteoarthritis