Shoulder Symptom Irritability Scale: A Single-Blinded Observational Study
NCT ID: NCT02995941
Last Updated: 2019-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
138 participants
OBSERVATIONAL
2016-12-31
2017-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Raters
No interventions will be administered. Raters will be state licensed as physical therapists working as outpatient physical therapists in the St. Luke's University Health Network.
No interventions assigned to this group
Patients
No interventions will be administered as a component of this study. Patients will be recruited from a convenience sample of consecutive patients presenting for physical therapy consultation for shoulder pain.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Patient Group
* Presenting with a chief complaint of shoulder pain, not extending to the neck, for outpatient physical therapy consultation
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Arcadia University
OTHER
Nova Southeastern University
OTHER
St. Luke's Hospital and Health Network, Pennsylvania
OTHER
Responsible Party
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Stephen Kareha, DPT
Director, Orthopaedic Physical Therapy Residency
Principal Investigators
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Alicia Fernandez-Fernandez, DPT, PhD
Role: STUDY_CHAIR
Nova Southeastern University
Stephen M Kareha, DPT
Role: PRINCIPAL_INVESTIGATOR
St. Luke's Hospital and Health Network, Pennsylvania
Locations
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Physical Therapy at St. Luke's - Washington
Washington, New Jersey, United States
Physical Therapy at St. Luke's - Hamilton
Allentown, Pennsylvania, United States
Physical Therapy at St. Luke's - West End Medical Center
Allentown, Pennsylvania, United States
Physical Therapy at St. Luke's - Bath
Bath, Pennsylvania, United States
Physical Therapy at St. Luke's - St. Luke's North
Bethlehem, Pennsylvania, United States
Physical Therapy at St. Luke's - Sports Medicine and Rehab Center
Bethlehem, Pennsylvania, United States
Physical Therapy at St. Luke's - Center Valley
Center Valley, Pennsylvania, United States
Physical Therapy at St. Luke's - Forks
Easton, Pennsylvania, United States
Physical Therapy at St. Luke's - Anderson
Easton, Pennsylvania, United States
Physical Therapy at St. Luke's - Emmaus
Emmaus, Pennsylvania, United States
Physical Therapy at St. Luke's - Hellertown
Hellertown, Pennsylvania, United States
Physical Therapy at St. Luke's - Macungie
Macungie, Pennsylvania, United States
Physical Therapy at St. Luke's - Northampton
Northampton, Pennsylvania, United States
Physical Therapy at St. Luke's - Orefield
Orefield, Pennsylvania, United States
Physical Therapy at St. Luke's - Quakertown
Quakertown, Pennsylvania, United States
Physical Therapy at St. Luke's - Stroudsburg
Stroudsburg, Pennsylvania, United States
Physical Therapy at St. Luke's - Wind Gap
Wind Gap, Pennsylvania, United States
Countries
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References
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Kareha SM, McClure PW, Fernandez-Fernandez A. Reliability and Concurrent Validity of Shoulder Tissue Irritability Classification. Phys Ther. 2021 Mar 3;101(3):pzab022. doi: 10.1093/ptj/pzab022.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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Shoulder Symptom Irritability Scale Rater Training
Other Identifiers
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2016-61
Identifier Type: -
Identifier Source: org_study_id
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