Lumbar Disc Herniation Clinical Trial
Official title:
A Cross-sectional Study of Patients, Who Diagnosed Lumbar Disc Hernia With or Without Sacroiliac Joint Dysfunction
In this study evaluated the prevalence of sacroiliac joint dysfunction in patients with lumbar disc hernia and examined the variations in clinical parameters cause by this combination.
Two hundred thirty-four patients already diagnosed with lumbar disc hernia were included in
the study. During the evaluation, sacroiliac joint dysfunction was investigated using
specific tests, pain levels with a Visual Analog Scale, and the presence of neuropathic pain
using the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale. Other clinical
assessments were performed using the Beck Depression Inventory, Health Assessment
Questionnaire, and Tampa Kinesiophobia Scale. Positivity in three out of six provocation
tests was adopted as a criterion for sacroiliac joint dysfunction.
Sample Size A power analysis using the formula n= t2pq / d2 was performed to determine the
sample size. Based on those data the investigators concluded that a minimum of 174 and a
maximum of 322 patients would be required to achieve significant results, and 234 patients
were enrolled.
Statistical Analysis The study data were expressed as mean plus standard deviation (SD) for
constant variables values and as number and percentage for categoric variables. The
chi-square test was used to analyze categoric variables. Results were evaluated at a 95%
confidence interval at a significance level of p˂0.05. The analysis was performed on
Statistical Package for the Social Sciences (SPSS) for Windows 16.0 software.
The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline
has been implemented in this manuscript.
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