Pain Clinical Trial
Official title:
Shoulder Symptom Irritability: A Single-Blinded Observational Study of Reliability and Construct Validity
The purpose of this study is to examine the reliability and use of the shoulder symptom irritability classification system for the purposes of determining an appropriate treatment intensity to better help people with shoulder pain.
Background Physical therapists regularly make decisions regarding intervention intensity
based upon pathoanatomy, symptom irritability, and impairment identification, but the
reliability and validity of classifying patients by symptom irritability is unknown.
Purpose Examine the reliability and use of the shoulder symptom irritability classification
system for the purposes of determining an appropriate treatment intensity.
Design Prospective repeated-measures single-blinded design to determine reliability and a
cross-sectional design will be utilized to aid in determining construct validity.
Methods Twenty-five (25) raters will be trained to make paired ratings in 90 subjects with
primary complaints of shoulder pain. Raters will record the shoulder symptom irritability
level and also select the appropriate intervention intensities for the subjects. Raters will
also be asked to choose anticipated interventions for subjects.
Data Analysis Prevalence-adjusted, bias-adjusted Kappa for ordinal scales (PABAK-OS) will be
the primary measure of reliability. Dependent upon the distribution of the data, other forms
of Kappa may be utilized to analyze the data most appropriately. To determine differences in
reliability between groups with and without clinical specialization, an independent t test
will be utilized with α = 0.05. Lastly, analysis of variance with post-hoc analysis will be
used to compare functional disability across different levels of irritability.
Significance This study addresses key gaps in the understanding of symptom irritability and
how it relates to clinical decision making. It is expected that symptom irritability should
logically drive intervention selection and intensity of rehabilitation interventions.
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