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Shoulder Symptom Irritability Scale: A Single-Blinded Observational Study

Shoulder Symptom Irritability: A Single-Blinded Observational Study of Reliability and Construct Validity

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02995941
Acronym
SSIS
Enrollment
138
Registered
2016-12-19
Start date
2016-12-31
Completion date
2017-07-31
Last updated
2019-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Shoulder Pain

Keywords

reliability, validity, classification, irritability, symptom, intensity, intervention

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Arcadia University
CollaboratorOTHER
Nova Southeastern University
CollaboratorOTHER
St. Luke's Hospital and Health Network, Pennsylvania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Rater Group Inclusion Criteria: * State licensure as a physical therapist and regular clinical practice with patients with shoulder disorders, defined as a minimum of 500 clinical hours per year in an orthopaedic setting with \>10% of patients with shoulder disorders

Exclusion criteria

* not meeting inclusion criteria Patient Group Inclusion Criteria: * Presenting with a chief complaint of shoulder pain, not extending to the neck, for outpatient physical therapy consultation

Design outcomes

Primary

MeasureTime frameDescription
Reliability of Shoulder Symptom Irritability ScaleDay 1 of data collection for each subjectTwo different raters will individually rate the shoulder symptom irritability of each patient. Raters will be blinded to the other's rating.

Secondary

MeasureTime frameDescription
Focus On Therapeutic Outcomes (FOTO) Functional ScoreDay 1 of data collection for each subjectThe 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.
Penn Shoulder Score (PSS)Day 1 of data collection for each subjectThe 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.
American Shoulder and Elbow Surgeons (ASES) Shoulder ScoreDay 1 of data collection for each subjectThe 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.
Numeric Pain Rating scaleDay 1 of data collection for each subjectThe 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.
Intervention intensityDay 1 of data collection for each subjectThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026