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NCT04381208 Clinical Trial

Medical Record, Physical and Neurological Data That Orient to the Diagnosis of Sacroiliac Joint Dysfunction

Low Back Pain Clinical Trial

Official title:
Datos de la Historia clínica y Del Examen físico y neurológico Que Orientan al diagnóstico de Dolor Originario en la articulación sacroilíaca

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04381208
Other study ID # 19-04-2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 19, 2019
Est. completion date May 1, 2024

Study information
Verified date April 2023
Source University of Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There are many patients coming daily to our office with the complaint of chronic lumbosacral pain radiating or not to the legs that need a proper diagnosis before any treatment is decided. The diagnosis, based mostly on radiological exams, carries a risk of failure to diagnose the sacroiliac joint as the cause of the pain. The study proposes that a quick interrogatory followed by a physical exam with the adequate provocative testing can raise the suspicion of the diagnosis that the pain is originating from the sacroiliac joint. Thereafter, a diagnostic sacroiliac joint block can be performed. The study aims to correlate findings from patient history and physical examination with eventual diagnosis.

Description:

This is a prospective cohort study of patients seeking care for chronic low back pain. All patients will undergo a detailed history and physical examination, followed by other indicated diagnostic testing. The analysis will correlate findings from patient history and physical examination testing with the eventual diagnosis. The goal of the study is to identify key historical and physical examination criteria that raise the suspicion for sacroiliac joint pain, which is commonly underdiagnosed. Failure to diagnose a health condition could lead to inappropriate surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date May 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient being evaluated in clinic for chronic low back or buttocks pain with or without radiation to the legs Exclusion Criteria: - Patient has already undergone surgery for the condition of interest - Inflammatory condition - Active cancer

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Complete clinical examination
Medical history-taking, physical examination with provocative maneuvers, radiographic imaging (if relevant), and sacroiliac joint block (if indicated), facet joint block (if indicated)

Locations
Country Name City State
Spain Hospital General Universitario de Valencia Valencia

Sponsors (2)
Lead Sponsor Collaborator
University of Valencia Hospital General Universitario de Valencia

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Final diagnosis Number of participants diagnosed with each condition of interest 1-2 months
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