Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy
NCT02971072
Acute Pain, Arthralgia
Eugene, Oregon, United States
View Trial DetailsNCT Number: NCT02995941
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.
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Notify Me18 year and older
All sexes
Observational
Physical Therapy at St. Luke's - Washington, Washington, New Jersey, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Rater Group
Inclusion criteria
Exclusion criteria
Patient Group
Inclusion criteria
Exclusion criteria
Time frame: Day 1 of data collection for each subject
Two different raters will individually rate the shoulder symptom irritability of each patient. Raters will be blinded to the other's rating.
Time frame: Day 1 of data collection for each subject
The FOTO functional scale for shoulder disorders27 has a standard error of the mean (SEM) of 1. with a minimal detectable change with 95% confidence (MDC95) of 3.60-10.88 functional score units.
Time frame: Day 1 of data collection for each subject
The Penn Shoulder Score (PSS)has demonstrated good test-retest reliability (ICC2,1 = 0.94) with a SEM90 of 8.5. The MDC90 is 12.1, and the minimal clinically important difference (MCID) was found to be 11.4.
Time frame: Day 1 of data collection for each subject
The ASES Shoulder Score has demonstrated good to excellent test-retest reliability (ICC = 0.61-0.96) with an SEM of 6.7. The MDC95 is 11.2,32 and the MCID was found to be 12.0.
Time frame: Day 1 of data collection for each subject
The Numeric Pain Rating Scale (NPRS) has demonstrated good reliability (ICC2,1=0.74)and responsiveness (MDC = 2.5, MCID = 1.1) in subjects with shoulder pain34 and excellent reliability in an upper extremity orthopaedic population.
Time frame: Day 1 of data collection for each subject
This project will analyze intervention choices from the primary raters for each of the 90 subjects utilizing PABAK-OS for correlation and independent t-test for group differences. It is expected that those subjects with high irritability will be prescribed interventions aimed at minimizing the physical stress to the affected tissue(s), while those subjects with low irritability will be prescribed interventions at a higher intensity to address the physical impairments.
St. Luke's Hospital and Health Network, Pennsylvania
Other
Shoulder Symptom Irritability: A Single-Blinded Observational Study of Reliability and Construct Validity
Acronym: SSIS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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